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- 2026-04-15 22:52:05
- Policy
- Benlysta is about to be listed as RSA (Refund·Expenditure)
- by Kim, Jung-Ju Dec 31, 2020 06:19am
- Benlysta (Belimumab), a new treatment for systemic lupus erythematosus by GSK, can be listed on the ‘Pharmaceutical Benefit List and Upper Limit Price List’ in February next year as soon as the administrative procedures are carried out sequentially. According to the pharmaceutical industry on the 28th, the government will promote insurance benefits for Benlysta 120mg and Benlysta 400mg. Benlysta is an injection approved by the MFDS for “the treatment of adult patients with autoantibody-positive active systemic lupus erythematosus being treated with standard therapy.” The number of domestic patients subject is about 835. In June 2013, after obtaining the approval of the MFDS, discussions took place in earnest at the Pharmaceutical Benefit Evaluation Committee following the application for insurance registration in May this year. As a result of negotiating drug prices with the NHIS in September, the pharmaceutical company agreed to refund a certain percentage of the initial amount of treatment and drug charges and the excess of the estimated cap to the NHIS during the RSA. According to the industry, Benlysta 120mg will be set at ₩182,696 and Benlysta 400mg will be set at ₩608,988. If applied, it is expected that the listing will be possible as early as February.
- Company
- Pradaxa and Xarelto to face generic market opening up soon
- by Kim, Jin-Gu Dec 30, 2020 06:03am
- Six South Korean pharmaceutical companies that successfully evaded Pradaxa (dabigatran) and Xarelto’s (rivaroxaban) patents would release generics in advance in July next year. The industry predicts the non-Vitamin K antagonist oral anticoagulants (NOAC) market currently led by the originals would take a sharp turn soon. Moreover, a generic version of dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus (vildagliptin) would be launched soon with the preferential sales rights. Also, Brilinta (ticagrelor) generic market would be opened late next year with 25 South Korean companies backed by the preferential sales right. ◆ Generic market for Pradaxa and Xarelto to open in July and October next year, respectively On Dec. 28, the Ministry of Food and Drug Safety (MFDS) and the Korean Intellectual Property Office (KIPO) announced the preferential sales rights would be granted on total 37 items from next year. First, four companies that overcame NOAC Pradaxa’s patent are to release their generics early on July 18 next year. Intro Bio Pharma’s Dabican, Aju Pharm’s Dabitran, Jinyang Pharm’s Pradabi and Huon’s Hubitran are the generic by the four companies. The four companies won the patent dispute against the original drug company Boehringer Ingelheim in January 2019. The obtained preferential sales rights are to last until April 2022. Another NOAC, Xarelto is also expecting its generic versions to emerge after Oct. 4 next year. Hanmi Pharmaceutical’s Riroxban and SK Chemical’s SK Rivaroxaban have been preparing for the launch. The wildcard is actually Chong Kun Dang, who challenged Xarelto’s product patent that neither one of the two companies could not overcome. If the court rules in favor of Chong Kun Dang by Oct. 4 next year, the company would be able to market the product even before Hanmi Pharmaceutical and SK Chemical regardless of the preferential sales rights. So far, the NOAC market was predominantly occupied by the original Eliquis, Pradaxa, Xarelto and Lixiana. But, soon the generics would tackle the market with the boost from Xarelto generic. In fact, Eliquis’ patent was challenged the first. In May 2018, Chong Kun Dang and Yuhan Corporation received the preferential sales rights and launched their generics after June 2019. Now the preferential sales period has ended and 12 generic companies are expanding their market share. And in next year, only Lixiana would be the one without generic competitors. Considering Lixiana generic would tap on the market in 2026, the original would dominate the market for a while longer. ◆25 Brilinta generics to rush into the market from November next year An antidiabetic DDP-4 inhibitor developed by Novartis, Galvus is expecting its generic version to be released in advance on Aug. 30 next year Ahn-gook Pharm (including Ahn-gook New Pharm) would exclusively practice the generic preferential sales right. The South Korean company succeeded in nullifying the extended original patent term. But the relevant patent dispute has not been settled completely, yet. As Novartis took the case to a higher court, the Supreme Court would be making the final decision. After Nov. 21 next year, Brilinta’s generics would be released early. About 30 pharmaceutical companies in South Korea challenged AstraZeneca’s antiplatelet drug patent. Ultimately, Chong Kun Dang successfully won 25 claims and received the preferential rights. ◆Preferential sales right period on Betmiga generic ended, nine generic companies ready to take off Meanwhile, some generics’ preferential sales benefit would be terminated soon. On Jan. 8, the benefits on desvenlafaxine generics would be taken away. Its original is Pfizer’s antidepressant Pristiq Extended Release Tablet. Whanin Pharm, Nexpharm Korea, Myung In Pharm and Hanlim Pharm got the preferential sales rights in last April. From Feb. 3, two mirabegron generics would no longer protected by the preferential sales rights. Astellas’ overactive bladder treatment Betmiga is the original. As Hanmi Pharmaceutical and Chong Kun Dang successfully challenged the patent, they respectively released Mirabek and Selebeta. As Betmiga generates around 70 billion won annually, the generic companies would aggressively jump into the market after February when the preferential sales period ends. Currently, nine companies, including Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, Daewoong Pharmaceutical and etc., have evaded the patent and some of them even completed the bioequivalence test and are fully prepared for the launch already.
- Policy
- Generic for Teribone was approved & the competition began
- by Lee, Tak-Sun Dec 30, 2020 06:02am
- Dong-A ST As a treatment for osteoporosis, generics have begun to be released in the latest bone formation promoting agents. Following Lilly's Forsteo, Dong-A ST's Teribone was also a generic version. The MFDS approved Terrosa 56.5μg (Teriparatide acetate) from BMIKOREA on the 28th. Terrosa is a generic of Teribone subcutaneous injection 56.5 μg and the same ingredient (Teriparatide acetate), which was approved by Dong-A ST in November 2015. This is the first time Generic for Teribone has been licensed. Teribone is a partially synthesized formulation of parathyroid hormone involved in bone formation, and is a product introduced in Korea by Dong-A ST from Asahi Kasei Pharma in Japan. In a clinical trial in Japan, it showed a fracture inhibitory effect that reduced the incidence of vertebral fractures to 78.6% compared to the placebo group. In particular, in Korea, it is treated like IMD because of improved ease of administration than Lilly's Forsteo (Teriparatide), which was licensed in 2002. Forsteo should be injected subcutaneously once a day, whereas Teribone can be injected once a month. In December 2016 by Forsteo and January 2017 by Teribone, benefits were recognized for patients who were ineffective or unable to use existing bone resorption inhibitors. Therefore, it has been in the domestic market in less than four years. Generic for Forsteo was released for the first time and was in competition. In October of last year, Forsteo's biosimilar'Terrosa cartridge' by Daewon was approved. This product was developed by Richter-Helm, a Hungarian-German pharmaceutical joint venture, and was given a re-examination for four years (until October 28, 2023) in recognition of its equivalence with the original. With BMIKOREA's approval of generic for Teribone this time, the number of promoting bone formation drugs of Teriparatide increased to four. Forsteo and Teribone's IQVIA sales last year were 21.7 billion won and 2.9 billion won, respectively. The gap between Forsteo and Teribone is widening. If generics such as BMIKOREA's Teria are sold in earnest following Daewon's Terrosa, it is believed that it will affect the market structure. Terrosa was released last May.
- Company
- Samsung Bio & Hanmi will participate at JPM 2021
- by Kim, Jin-Gu Dec 30, 2020 06:02am
- At the 38th JPMorgan Healthcare Conference held this year, Kwon Se-chang, President of Hanmi, announces R&D strategies. This 39th event will be held online under the influence of COVID-19 20 domestic pharmaceutical bio companies announced their participation in the JPMorgan Healthcare Conference, which will be held early next year. Among them, Samsung Biologics was the only one to be assigned a main session presentation. Celltrion, who attended every time, declared absence after 10 years. The JPMorgan Healthcare Conference, which marks its 39th year next year, is the largest conference in the bio field where global pharmaceutical companies share new drug R&D achievements and status, and understand trends in the global pharmaceutical industry. This conference will be held online from January 11th to 14th due to COVID-19. ◆Samsung Biologics debuts as new president, John Rim There were about 20 domestic companies that announced their participation in the JPMorgan conference by the 28th. Samsung Biologics is one company that has been assigned the main track. The announcement was scheduled for the morning of the 13th. Although the details of the announcement have not been decided yet, it is attracting attention in that it is the first official stage of the newly appointed John Rim. Hanmi, Hugel, HK inno.N, LG Chem, and Genexine were assigned to announce an auxiliary session (Emerging Market Track). Hanmi is scheduled to announce on the afternoon of the 11th and the rest of the companies on the morning of the 13th. Hanmi has not yet decided on a specific announcement. Last year, they announced HM15211, which is being developed as a treatment for NASH. Hanmi has released three HM15211-related research results in succession this year at the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. The Food and Drug Administration (FDA) has designated this substance as Fast Track. HK inno.N is participating in this event for the first time. HK Innoen plans to introduce autoimmune disease treatment and NASH treatment, including Kcab. Genexine will introduce the business strategy of Continuous Interleukin-7 (GX-17). GX-17 is a substance under development as an anticancer drug for various indications and a treatment for COVID-19. Celltrion, a regular member of JPM conference, decided to absent after 10 years. Celltrion was initially reported to have been assigned to the main track along with Samsung Biologics, but will not attend this event to focus on the development of corona antibody treatment. ◆Bio companies such as Enjikem·Genome & Co have also declared participation Enjikem·Genome & Co·ABL Bio·Crystalgenomics· AptaBio·SCM LifeScience Co Ltd·Cellivery·KoBioLabs·Bioleaders·Eoflow are also planning to participate in this JP Morgan conference. Enjikem introduces EC-18, which is being developed as a treatment for COVID-19, and a treatment for oral mucositis caused by chemoradiation on cancer. Phase II clinical trials for oral mucositis are in the final stage. The company plans to announce the results of Phase II in the first half of next year. Genome & Co plans to discuss technology transfer of pipelines such as new immune checkpoint inhibitors and autism treatments. At last year's JP Morgan conference, discussions on additional co-development of GEN-001, a microbiome-based immune anticancer drug, jointly developed with Merck and Pfizer will also be in progress. ABL Bio plans to focus on its dual antibody platform Grabody-B, which increases the penetration rate of the blood-brain barrier, and ABL301, a Parkinson's disease treatment that introduced it. Crystalgenomics will be presenting the data of Ivaltinostat, CG-745', a new drug candidate for anticancer and antifibrosis treatment. AptaBio introduces the company's core platform technology and pipeline, focusing on the diabetic nephropathy treatment APX-115. APX-115 is undergoing multi-national phase II clinical trials in Europe. Patients started medication for the first time in September, and interim data is expected to be available in the first quarter of next year. Cellivery will announce the efficacy and development status of its immunotherapy iCP-NI as a treatment for COVID-19. In addition, it plans to release data on the efficacy of iCP-Parkin, a dementia treatment drug that utilizes TSDT, a drug substance transmission technology in vivo. KoBioLabs shares the clinical progress of major microbiome new drug pipelines, such as KBLP-001 and KBLP-002, the immune disease tasks that are undergoing global clinical trials. In addition, KBLP-004, a microbiome-derived effective substance-based NASH treatment, plans to explore the possibility of joint research and technology transfer from a preclinical study based on the research results on a new target identified by KoBioLabs. Bioleaders introduces research and clinical programs using Huma MAX and MucoMAX technology, which are self-developed new drug platforms. It is also planning to discuss the licensing of anticancer drugs and Sacopenia candidates as well as clinical trials for cervical intraepithelial neoplasia and Duchenne muscular dystrophy treatments. Expectations and concerns coexist in the pharmaceutical industry over this event, which is held online for the first time in 39 years. While there are concerns that the opportunity for business meetings will decrease, there is also an expectation that more active meetings will be possible because there are no temporal and spatial constraints.
- Company
- Successful year for Korean new drug, biosimilar and test kit
- by An, Kyung-Jin Dec 29, 2020 06:09am
- The year 2020 was a fruitful year for the South Korean companies and their R&D outcomes showcased in the global market. Yuhan Corporation licensed out its novel lung cancer treatment ‘lazertinib’ to Janssen for 100 billion won. SK Biopharmaceutical put the gears in motion for its anti-epileptic drug Xcopri sales in the U.S. market. The previously neglected diagnostic testing kit manufacturers emerged amid COVDI-19 as the success cases of the infectious disease prevention in South Korea. Samsung Bioepis and Celltrion broke the export record with their competitively priced biosimilars. ◆Yuhan’s Lazertinib confirms 100 percent response rate, the milestone pays out 100 billion won A number of new drugs developed by South Korean pharmaceutical companies have been impactful in the global market this year. An image of Yuhan Corporation HQ Yuhan met the development milestone for the novel lung cancer drug lazertinib, licensed to Janssen Biotech two years ago, and received a milestone payment of total USD 10 million paid out in April and November this year. Lazertinib is a third generation epidermal growth factor receptor (EGFR) targeted therapy Yuhan licensed out to Janssen Biotech in November 2018. The Korean company signed the deal with the 50 million-dollar upfront payment and maximum payment of 1.25 billion dollars including clinical, approval and sales milestones. At the ‘European Society for Medical Oncology (ESMO) Virtual Congress 2020’ convened in last September, Janssen presented a Phase Ib interim report on confirming an outstanding response rate in lazertinib combined with amivantamab. 20 non-small cell lung cancer (NSCLC) patients with no previous treatment history, who have either EGFR exon 19 deletion or L858R mutation, have been treated with the lazertinib combination therapy and reached 100 percent objective response rate (ORR) in seven months. Besides lazertinib, Yuhan has also inked five new drug technology license out deals in last two years. When the non-alcoholic steatohepatitis (NASH) treatment candidate, licensed out to Boehringer Ingelheim, completed the non-clinical toxicity test in last April, Yuhan acquired 10 million dollars. Within this year, Yuhan generated total of 77.9 billion won for the license out contracts, which vastly exceeds 57.1 billion won, the operating income accumulated up to third quarter. As the value of licensing out new drug commercialization has gone up, the Korean company successfully overcame the risk of faltering sales with expanded R&D investment. ◆SK’s Xcopri commercialized in the U.S. New drugs developed by SK Biopharmaceutical’s own technology are also seeing some satisfying commercialization outcomes. SK Biopharmaceutical has generated 9.9 billion won as of the third quarter this year. The statistic report found a narcolepsy treatment Sunosi (solriamfetol), licensed out to Jazz Pharmaceutical in 2011, generated 4.6 billion won and a partial-onset seizure treatment Xcopri (cenobamate) generated 5.3 billion won. Although the figure is insignificant compared to last year’s sales 123.6 billion won, making almost 10 billion won from the license out sales was remarkable. Currently, SK Biopharmaceutical has diversified commercialization strategy for Xcopri in respective regions. For the world’s biggest U.S. market, the Korean company’s subsidiary in the region SK LifeScience directly launched the product in last May. Also the company plans to directly handle the Xcopri commercialization in Japan, China and South Korea, but for other regions like Europe, the company plans to seek a local partner. ◆COVID-19 testing kit '99.9 percent for export' Testing kit companies in South Korea had an unexpectedly successful year due to the pandemic. One of the top companies who benefitted from the global pandemic is a molecular testing kit specialist company Seegene. The company’s accumulated operating income up to the third quarter skyrocketed by 24 times from 17.3 billion won last year to 418.7 billion won this year. During the three quarters, the company generated 683.5 billion won of sales revenue, which is more than eight-folds of last year’s. Among all healthcare companies in South Korea, Seegene came in second with the operating income following Celltrion making 245.3 billion won. The operating income against sales revenue marked 64.9 percent. If the sales revenue actually exceeds the company’s projection for this year at 1 trillion won, the company would be making almost ten-folds of last year at 122 billion won. Seegene COVID-19 test kit Seegene had a record breaking performance by proactively developing COVID-19 testing kit to help diagnose the infectious disease in suspected patients during the early stage of COVID-19 outbreak. The company exports the COVID-19 relevant products out to 70 countries. As of the third quarter, the 94.4 percent, or 645.4 billion won, of the overall sales revenue was from the export. Regardless of the swift distribution of COVID-19 vaccine in the U.S. and other countries, the industry projects the worldly demand for the testing kit would remain high for a while. ◆Celltrion and Samsung Bioepis break quarterly revenue Amid COVID-19, South Korea’s top biosimilar companies continued to exceed top export records with successful portfolio. Celltrion (left) and Samsung Bioepis R&D laboratory (Source: respective companies) Celltrion Healthcare easily passed last year’s annual sales revenue at 1.10 trillion won by earning 1.24 trillion won as of the third quarter this year. Celltrion Healthcare sells Celltrion’s biosimilar products to global distributors. Basically, Celltrion Healthcare’s sales revenue indicates Celltrion’s antibody biosimilar export volume. Mabthera’s biosimilar Truxima, prescribed to patients with blood cancer and rheumatoid arthritis, topped the leader board by selling 590.5 billion won as of the third quarter. Celltrion’s U.S. partner Teva reported Truxima’s market share reached 20.4 percent as of September, which was only 11 months after the U.S. market launch. The company also noted the drug is threatening the original’s top position with the drug’s strength of being the first rituximab biosimilar anticancer treatment. Breaking its own top record, Samsung Bioepis’ third quarter sales revenue of 236.9 billion won grew 2.3 percent from last year at 231.6 billion won. Although COVID-19 has slowed down the growth, the company made a new quarterly revenue record in a year as the biosimilar sales in Europe surged. Samsung Bioepis’ European partner Biogen said three biosimilar products combined—Benepali, Flixabi and Imraldi—have earned 27.9 million dollars (approximately 235.7 billion won) in the last third quarter. The Korean company’s Enbrel biosimilar Benepali was the first product to tap on the European market, and it made 124.20 million dollars, jumping 7.2 percent from last year same time.
- Policy
- Vaccination will be given for medical staff and the elderly
- by Lee, Jeong-Hwan Dec 29, 2020 06:09am
- The Democratic Party of Korea, the government, and Cheongwadae have decided to start vaccinating COVID-19 from February of next year. On the 27th, the Party, the government, and Cheongwadae held a party government council at the National Assembly to discuss support measures for COVID-19 damage, measures to secure treatment and isolation facilities, and vaccine contracts. The Chief Presidential Secretary Noh Young-min said, "We have already secured enough COVID-19 vaccines to protect our people." He said, "Vaccinations for medical staff and the elderly will begin by February next year. " He said, "Countries around the world will start vaccinating the general public in the second quarter of next year. We will begin vaccinating the general public at a similar time." He explained, "The timing of the formation of group immunity will be similar to that of foreign countries, or it will be faster. The government is making all-out efforts to accelerate this period and is making progress." Lee Nak-yon, Leader of Democratic Party of Korea said, "We will mobilize all available means for the disaster damage subsidy to be executed from January in order to further help COVID-19 victims. We will focus on overcoming COVID-19 outbreak, stabilizing people's livelihood, and recovering the economy.” Kim Tae-nyeon, floor leader, asked, "Financial authorities have an extraordinary awareness of the war situation and drastic financial execution. I request that the government's customized emergency damage subsidies be expanded from '₩3 trillion + α." Prime Minister Chung Sye-kyun said, "We will promote rental support and income preservation measures for small business owners and the underprivileged. We will prepare necessary beds in advance with the possibility of worsening COVID-19."
- Policy
- What are the major systems of the MOHW, the MFDS, & the KCDA
- by Kim, Jung-Ju Dec 29, 2020 06:08am
- From next year, medical expenses for rare diseases and diseases subject to the exempted calculation will be expanded. In addition, the national infrastructure necessary for rapid introduction and verification of the safety and effectiveness of COVID-19 vaccines and treatments using high-tech new technologies will be expanded. The Ministry of Economy and Finance announced on the morning of the 28th a summary of the government's business plan for 2021, which will have a great impact on the public among all government ministry projects next year. In the health care and pharmaceutical industry sectors, reinforcement of coverage for rare and essential targets and reduction of entry into essential medical care and advanced and precision technologies are typical. ◆Ministry of Health and Welfare = Diseases subject to the exempted calculation of health insurance will be expanded from January. The exempted calculation is a type of guarantee that reduces the estimated copayment rate to 10%. The targets for promotion are patients with severe incurable diseases, rare diseases such as keratoconus patients, or 68 rare diseases such as hydranencephaly and severe atopic dermatitis. Newly designated as a disease subject to exempted calculation. For these diseases, the current hospitalization co-pay rate is 20% and the outpatient co-pay rate is 30-60%, and from next month, the inpatient and outpatient co-pay rates will be 10%. In August 2017, health insurance coverage for chest (breast) and echocardiography will be expanded according to measures to strengthen health insurance coverage. The MOHW will expand and apply echocardiography in order from the first half of next year to the chest (breast) and from the second half of next year. Until now, the government has completed health insurance coverage. Beginning with the upper abdomen in April 2018, ultrasound examinations in the lower abdomen and the urinary system in February 2019, the emergency and critically ill patients in July of the same year, the male genitalia in September of the same year, the female genitalia in February this year, and the ophthalmology sector in September will be expanded. In the meantime, despite the high cost-effectiveness of ultrasound, insurance has been applied mainly to patients with four major serious diseases (cancer, heart, cerebrovascular, rare intractable teeth) due to financial burden, but from now on, the disease is affected by the medical judgment of the doctor. Health insurance benefit will be expanded if there is a need for examination due to a disease or suspected disease. The government announced that it plans to discuss specific insurance coverage and medical cost reduction effects, and to prepare related legal procedures later with the medical community. The government has been expanding responsible medical institutions in each region in order to close the gap in essential medical care between regions since last November. This is a project to strengthen cooperation in essential medical services centered on public hospitals, focusing on 15 regionally responsible medical institutions such as national university hospitals, and 35 regionally responsible medical institutions such as local medical centers. The main goal is to establish a system of direct and essential medical cooperation. In addition, the business area in the essential medical field is expanded step by step to develop a cooperation model and carry out the project. It also promotes referrals and transfers between partner organizations. The MOHW is carrying out a project to revitalize medical referrals with the main focus of improving the reimbursement rate system so that exchange of medical information can be activated through an electronic method such as electronic record. This is a method in which a medical institution in a non-capital region increases the fee when it is requested above the general hospital level (including specialized hospitals) in the same city. As a result, the government is expecting to establish the function of each type of medical institution and to ease the focus of patients in large hospitals. In addition, patient treatment and image information will be exchanged through an electronic method so that patient’s referrals can be made. The government explained that this will increase patient safety by ensuring continuity of treatment at the time of referral and return, and increase patient convenience as patients do not have to submit treatment information directly. In addition, it added that it is possible to expect efficient use of medical resources and savings in health insurance finances by reducing duplicate examinations and imaging. In addition, the reimbursement rate system will be improved so that medical institutions in non-metropolitan areas can induce referrals to general hospitals, general hospitals, and specialized hospitals within the same city (17 administrative districts) to strengthen the connection of medical institutions within the local community. A plan is also underway to shorten the period of entry into the medical field with new medical technologies through regulatory innovation of medical devices. The MOHW expanded the targets for the evaluation of innovative medical technologies from last November so that cutting-edge medical technologies such as digital therapeutics and precision medicine can enter the medical field early. Specifically, the number of innovative Health Technology evaluation targets has been expanded from 6 to 9, and the disease group, which was limited to 4 fields, has been abolished, enabling the use of advanced medical technology for various diseases with a large impact on society. ◆The KCDA = The KCDA will expand supportable diseases such as medical expenses for rare diseases from January next year. The KCDA announced a list of additionally designated rare diseases in October this year, and plans to increase support for rare diseases such as medical expenses support and expansion of target diseases for diagnosis next year. From January, the number of diseases subject to the medical expense support project for rare diseases has expanded from 1,014 to 1,078, supporting health insurance copayment. In accordance with the designation of new rare diseases, the number of diseases subject to “genetic diagnosis support for rare diseases” will also be expanded from 126 to 175. Online applications for medical expenses support for people with rare diseases will also be expanded. The scope of the online application for the “medical expense support project for people with rare diseases,” which started in March this year, will be expanded from next September. Specifically, it will expand from low-income health insurance subscribers who do not currently have a support obligation to all low-income household health insurance subscribers, medical benefit patients, and the next higher-ranking out-of-pocket patients who are eligible for deductible deductions regardless of whether they are obligated to support or not. In addition, from next month, free vaccinations for the elderly pneumococcal (PPSV23) will be expanded from the current public health center to a consigned medical institution. The government is temporarily expanding operation of vaccination institutions to consigned medical institutions from June 22 to the end of this year in response to COVID-19 by public health centers this year. If it is expanded to entrusted medical institutions, about 14,000 sites will be added from 256 existing ones. In addition, the KCDA strengthens the protection of personal information exposure of patients with infectious diseases. In the event of an infectious disease crisis, personal information such as the name and detailed address of residence that are not related to the prevention of infectious disease should be excluded when disclosing the route of movement of the patient with an infectious disease. This project will be applied from the 30th of this month. ◆The MFDS = The MFDS will support education and training to nurture experts in regulatory science to strengthen the safety supply of biohealth products and domestic industrial competitiveness from next year. The government explained that it is essential to develop safety technologies that can evaluate product safety, effectiveness, quality and performance in order for biohealth products to which future technologies (AI, application of big data, etc.) are applied to the market quickly. Accordingly, the MFDS will select five excellent universities in Korea and provide more than ₩500 million per year to each university for five years in order to cultivate professional researchers who research safety technology while learning legal knowledge about the licensing of biohealth products In addition, universities that have received applications are planning to cultivate more than 600 new researchers and field experts by establishing master's and doctoral degrees in regulatory science in the field of food and medicine at graduate schools. Product development and safety management for COVID-19 will also be strengthened. The MFDS is planning to reinforce infrastructure, such as verification of the safety and effectiveness of COVID-19 vaccines and treatments using state-of-the-art new technologies, and national testing equipment necessary for rapid domestic supply. All vaccines, including the COVID-19 vaccine, must undergo a lot release from the MFDS after reviewing data on manufacturing and quality control and verification tests for domestic supply. Accordingly, for the rapid and safe national lot release of COVID-19 vaccine, advanced analysis equipment will be added and newly introduced, and a special laboratory will be built. In addition, in order to accelerate the development of a vaccine and treatment for COVID-19, the country plans to designate an “IRB” for rapid review. It shortens the entry period for clinical trials by conducting an integrated review (one time) by IRB for approval of clinical trials conducted by various medical institutions. To this end, the MFDS will regularly review major new information such as side effects of clinical trial drugs to prevent harm to patient safety in advance. In addition, it will provide a platform that can be used for new drug development by transparently disclosing information from clinical trial approval to results, and release a lot of vaccines quickly and safely to successfully overcome COVID-19. In addition, a design for the expansion of patient treatment opportunities and the rights, safety and welfare of clinical trial participants will be established. Mandates education to prevent recidivism in people who commits a crime related to narcotics. Since the 4th of this month, the MFDS has been convicted by a court or notified of a summary order as a mandatory education to prevent recidivism of people who commits a crime related to narcotics has been implemented. The crime related to narcotics is a policy that compulsory completion of an order to attend education or rehabilitation programs necessary to prevent recidivism within 200 hours. In addition, safety inspections for overseas direct purchases will be further expanded. Even though the rate of nonconformity such as overseas fast-purchased food is very high, there are only about 1600 purchase inspections as of this year, and there is a possibility of domestic inflow of hazardous food, and the government inspects it at twice the level of the previous year (3,000 cases) from next year. It plans to expand the number of cases. In particular, the MFDS plans to reinforce the safety management of foods purchased directly from overseas by diversifying inspection targets such as foods of vulnerable groups and foods that are domestic issues from the existing tests focused on improving sexual function, strengthening muscles, and diet food. The MFDS also implements an innovative medical device software manufacturing company certification system to promote rapid commercialization of innovative medical device software. Innovative medical device software refers to a software-only product among medical devices with significantly improved safety and effectiveness compared to existing medical devices by applying advanced technologies such as artificial intelligence (AI) and virtual reality (VR). When manufacturing licenses for innovative medical device software of certified companies, some of the submitted data will be exempted so that innovative products can be quickly released to the market. The special exceptions for certification and permitting of manufacturing enterprises will be implemented within the first half of next year when the relevant regulations are revised.
- Policy
- The MFDS announces it will shorten the lot release period
- by Lee, Tak-Sun Dec 29, 2020 06:08am
- The MFDS announced on the 27th that a preliminary review is currently underway for three items of COVID-19 vaccines developed by overseas pharmaceutical companies, and that a domestic antibody treatment development company is planning to apply for use approval within this month. The MFDS said that it would approve the COVID-19 vaccine with a target within 40 days after application for approval and within 20 days of national lot release. According to The MFDS, the drug approval process begins when a manufacturer or importer applies for product approval, and the company submits the data stipulated in Articles 31 and 42 of the Pharmaceutical Affairs Act to the MFDS' Integrated Drug Information System. The main data to be submitted are non-clinical, clinical and quality data. Non-clinical data is to verify the safety and effectiveness through animal testing before administering a drug to humans, and clinical data can be viewed as data that test the safety and effectiveness of administering drugs to humans (patients). Quality data relates to the manufacturing process control, standards and test methods for quality control of the drug. The MFDS operates a dedicated COVID-19 vaccine/treatment approval review team, and final approval is given by combining the review results of experts in each field and the opinions of external experts such as the Central Pharmaceutical Affairs Review Committee if necessary. The MFDS aims to shorten the existing processing period (180 days or more) through rapid approval review and process it within 40 days. In addition, vaccines, which are biological products, can be distributed and sold only after the national lot release, where the country checks the quality once more. This is a procedure to go through the safety and effectiveness of the vaccine once more. National lot release must be applied by all domestic distributors and approved by the MFDS by conducting a quality inspection for each serial number. In the case of the COVID-19 vaccine, it plan to shorten the existing treatment period (usually 2 to 3 months or more) to treat it within 20 days. Pharmaceuticals can be manufactured or imported only after obtaining item approval, but Article 85-2 of the Pharmaceutical Affairs Law provides for special manufacturing and import procedures. The heads of relevant ministries may request special manufacturing or special import from the head of the Ministry of Food and Drug Safety in order to adequately cope with the pandemic of infectious diseases, and may manufacture or import pharmaceuticals that have not been approved for special manufacturing or import. .Meanwhile, the MFDS reported that a number of companies such as AstraZeneca, Pfizer, Modena, and Janssen (Johnson & Johnson) are conducting phase III clinical trials for COVID-19 vaccine .As of the 25th, Pfizer's vaccine has been approved for emergency use in eight countries (UK, Bahrain, Canada, Saudi Arabia, the United States, Mexico, Kuwait and Singapore) including the United States and the United Kingdom, and conditionally licensed in the European Union and Switzerland .And the Moderna vaccine was approved for emergency use in the United States .In Korea, five products are currently undergoing clinical trials, and most of them are undergoing initial clinical trials (Phase I or Phase I/II) .As for the treatment, Lilly and Regeneron are conducting phase III clinical trials for antibody treatments, and they have been approved for emergency use in the United States .In addition, a clinical trial is in progress to add the efficacy and effect of COVID-19 treatment to existing drugs such as Baricitinib (arthritis treatment) .In Korea, it is said that a total of 15 products (13 components), including antibody treatments being developed as COVID-19 treatment, are undergoing clinical trials.
- Company
- High import drug dependency, Korean drug ratio keeps falling
- by Chon, Seung-Hyun Dec 29, 2020 06:08am
- The dependency on imported pharmaceutical products in the South Korean market seems to be getting higher. The volume of the country’s locally manufactured complete product and active pharmaceutical ingredient (API) has fallen for two consecutive years. The self-sufficiency in API has even halved in just two years. According to the ‘Food and Drug Statistics 2020’ published by the Ministry of Food and Drug Safety (MFDS) on Dec. 25, the production of Korean-made complete drug has increased by 7.0 percent this year, compared to last year, reaching 19.84 trillion won. The complete product import generated 4.77 trillion won, surging 20.0 percent this year compared to 2018, when the import volume was also increased by 13.0 percent hitting 5.25 trillion won. The ratio of complete drug manufacturing self-sufficiency in 2018 was 74.1 percent, which was 1.5 percent lower than the previous year. The self-sufficiency ratio indicates the proportion of the Korean-made products in the overall market. The self-sufficiency ratio in complete product in 2017 reached 77.6 percent, and the figure has been dipping for last two consecutive years and marked the lowest since 2008, when the statistics disclosed for the first time. The ratio in 2008 marked 83.4 percent. The figure fell below 80 percent in 2012 and then it has been slipping down ever since. The industry analyzes the drop in Korean-made complete drug’s local market share would have been affected by the heightened preference on imported drug and disinterest in generics. As an off-patent new drug pricing is brought down to level with generics, the prescribers appear to prefer the originals more than the generics. In South Korea, the original’s reimbursed pricing is reduced to 70 percent of the initial pricing when a generic is released to the market. And the pricing falls again to 53.55 percent of the initial pricing a year after the pricing adjustment. As for generic, the initial upper limit pricing is set at maximum 59 percent of the original pricing before the patent expiration, and it would be reduced down to 53.55 percent the initial pricing after a year like the original. The yearly ratio of Korean-made complete drug in the local market (Unit: percent) Source: MFDS Meanwhile, the dependency on the imported API is rising steeply. South Korea has manufactured 2.47 trillion won worth of API in last year, which was 3.6 percent less than the year before. But API export volume was increased 13.4 percent more than 2018 with 1.98 trillion won, while the import volume was increased 11.6 percent more with 2.53 trillion won. The self-sufficiency ratio in API marked 16.2 percent making over 10 percent point drop. After reaching 35.5 percent in 2017, the figure took a significant fall for two consecutive years. Last year’s API self-sufficiency ratio did not even make it to the halfway point of 35.4 percent recorded in 2017. The pharmaceutical companies evaluate the import volume surged as the Korean manufacturers sought after inexpensive imported API to lessen the production cost. In last year alone, USD 796.96 million worth of Chinese-made API were imported, which was 17.5 percent more than the year before with 678.09 million dollars. Compared to 653.66 million dollars of import in 2017, the volume in last year leaped by 31.6 percent in two years. Meanwhile, the Indian-made API import volume also jumped from 171.89 million dollars in 2017 to 221.14 million dollars last year.
- Policy
- Stop the politicization of COVID-19!
- by Lee, Jeong-Hwan Dec 28, 2020 07:25pm
- Cheongwadae directly refuted criticism from some media and opposition parties that President Moon Jae-in and the government coping with the lack of efforts to secure COVID-19 vaccine supplies. Since last April, President Moon's instructions regarding securing the corona vaccine have been disclosed, and a strong appeal to stop the political issue of quarantine and vaccines was also included. On the 22nd, Cheong-Wadae spokesman Kang Min-seok said, "The opposition party and the media are exaggerating and distorting as if President Moon didn't care about securing the vaccine, increasing public distrust. We hope this will stop the politicization of vaccines,” he said. This is a direct refutation of the situation that some media recently reported with the title of ``reproaching the staff belatedly'' over securing the quantity of corona vaccine, and criticizing opposition parties. Spokesman Kang said, "President Moon instructed at the staff meeting on the 30th of last month to'secure excess supplies and do not think roughly.'" "On this day, President Moon Jae-in twice said to secure enough, and this was not the first time in November," he said. "Some media said that President Moon did not accept the expert's direct vaccination on February 2, but it was January 20 that the first coronavirus confirmed in Korea." He pointed out, "It is said that he refused to speak directly in June, but it is not true as a result of confirming the minutes of the meeting." According to spokesman Kang, President Moon visited Institut Pasteur Korea in Seongnam City on April 9 and presided over the'Joint Meeting for Corona Treatment and Vaccine Development Industry-Academic Cooperation. At the meeting that day, President Moon pledged, "We will definitely help in the development of treatments and vaccines." On that day, President Moon promised to invest 210 billion won in vaccine development and will stockpile the developed treatment and vaccine (even when the corona is over).” On April 10, President Moon made a phone call with Chairman Bill Gates (Bill & Melinda Gates Foundation) and agreed to expand cooperation in the development of a COVID-19 vaccine and treatment. In May, after the call, the Gates Foundation supported SK Biosciences with $3.6 million in vaccine development. This month, it will select a target of 10 million dollars. On April 12, under the direction of President Moon, a pan-governmental support group for the development of a vaccine for corona treatment was formed and is still in operation. Two days later, at the State Council meeting (April 14), President Moon stressed to the State Council members that "we should use it as an opportunity to increase the level of biopharmaceuticals within the speed of vaccine and treatment development." At the meeting of the chief and advisors on July 20, he said, "The launch of the Smart Korea Fund will play a role in supporting vaccines and treatments." The next day, at an internal meeting, it was reported that SK Bioscience had decided to commission AstraZeneca vaccine. And he urged "supply enough supplies." At a Cabinet meeting on September 8th, President Moon encouraged the development of vaccines and treatments in line with the promotion of the KCDA and ordered "to increase the response to infectious diseases through the establishment of the National Institute of Infectious Diseases under the National Institute of Health and support for vaccine development." At the internal staff meeting on the 15th of the same month, after checking the corona vaccine situation, he instructed "to secure a sufficient amount of vaccine through Kovax and global pharmaceutical companies." The COVAX Facility is a multinational organization for the supply of Corona 19 vaccines. On October 15, President Moon visited SK Bioscience, a corona vaccine development company, to check the development status and encouraged it. President Moon said, “I will not spare support until the end, until it is definitely successful. SK Bioscience is in consultation with global vaccine companies such as AstraZeneca and Novavax. It will be a great force in securing.” He also encouraged, "Even if another country develops first, even if the corona passes, develop until the end for vaccine sovereignty. Be sure to end it." President Moon attended a bio industry event held at Yonsei University International Campus on the 18th of last month and said, "We will show progress in the development of vaccines and treatments, and will introduce antibody treatments and plasma treatments to the market as soon as possible from the end of this year." On the 24th of the same month, at an internal staff meeting, President Moon ordered, "The question of vaccine safety should be based on science and medicine, unless we are careless in the delivery process. Do our best to secure it." On the 8th, President Moon instructed Hong Nam-ki to provide support for securing additional vaccine supplies even if there is a financial burden at a meeting with the deputy prime minister for economic affairs and Minister of Economy and Finance. Spokesman Kang said, "It is a brief summary of the president's vaccination-related actions." He explained, "Because of the presidential order, the government has provided a budget of 218.6 billion won (including the third additional KRW 1936 billion) to secure vaccines. In addition, it has secured 4 million overseas vaccines." He said, "As the President mentioned at the invitational meeting of the fifth part, it is inevitable for the producing country that provided financial and administrative support to the vaccine to inoculate its country first. The vaccination time is also planned to be accelerated with the best efforts." He said, "Because children and adolescents were not subject to vaccine clinical trials, please pay attention to the opinions of experts that 4,400 is a vaccine for the entire population." He said, "The government is making every effort to secure additional quantities and shorten the vaccination period."
