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- 2026-04-14 03:36:11
- Policy
- MFDS orders minimized use of varenicline
- by Lee, Tak-Sun Jul 12, 2021 05:58am
- The Ministry of Food and Drug Safety ordered minimized use of the smoking-cessation treatment, ‘varenicline.’ The measure was announced 3 weeks after safety investigations had started for the products, from the 22nd of last month. The MFDS announced that it has issued a Dear Healthcare Professional Letter regarding the precautions to take when prescribing and using smoking cessation treatment aids using ‘varenicline,’ with regards to the recall of these products abroad due to N-nitroso-varenicline impurities found in some of its products. The MFDS explained that the letter was issued as a precautionary measure for domestic HCPs and patients, as the possibility of nitrosamine impurities cannot be completely ruled out, although the results of the safety investigations that started on the 22nd of June have not been released yet. Measures to recall some of the finished drug products containing ‘varenicline’ are already in force in Canada and the U.S. In the letter, the MFDS informed the experts and patients of the types of finished drugs and their related information. To HCPs including doctors and pharmacists, the ministry recommended minimizing the use of finished drug products that contain ‘varenicline’ and asked experts to consider other treatment methods, if possible, according to the patient’s condition, until the investigation results regarding the nitrosamine impurities are announced. To patients who are using affected products, the ministry advised them to continue using the treatment until the HCPs provide an alternative treatment, and to consult with doctors and pharmacists if any health concerns arise while using the medications. The ministry also added that it is working closely with relevant companies to ensure that the ongoing investigation for impurities is completed as soon as possible and that it will announce measures as soon as the key results are released. Also, products that do not complete testing by August 31st will be suspended from sales as a precautionary measure until it is confirmed that no impurities are detected in the products. An official from MFDS said, “Public safety is of our utmost priority, and we plan to quickly implement necessary measures including completing the development of test methods for impurities and collecting and inspecting related products if necessary.” The letter was issued in the midst of the confusion arising in the field as the Korean health authorities had made no measures after ordering investigations for impurities despite ongoing product recalls for some varenicline products in the U.S. and Canada.
- Policy
- Ultra-high-priced drugs(Kymriah) need coverage within a year
- by Lee, Jeong-Hwan Jul 11, 2021 07:05pm
- In order to commercialize high-tech biopharmaceuticals, which are evaluated as ultra-high-priced new drugs, it has been argued that a policy to recognize insurance benefits should follow beyond Expedited Review within at least a year of approval. It is pointed out that although the enactment of the Advanced Regenerative Bio Act in 2019 established a quick marketing permit system for serious and rare diseases without alternative treatments, there is still no system to register benefit. Professor Kim Won-seok of the Department of Blood Tumor Medicine at Samsung Medical Center will present the presentation at the National Assembly's debate on how to improve accessibility of patients with advanced biopharmaceuticals on the 9th. The debate was hosted by Kim Min-seok, chairman of the National Assembly's Health and Welfare Committee, and Choi Hye-young, a member of the Democratic Party of Korea. Professor Kim Won-seok, who is in charge of the presentation, announced the "Status of Advanced Biopharmaceutical Development and Treatment in Advanced Countries." Advanced bio-medicine is a drug based on cells, tissues, and genes, and many treat the source of the disease and show a full recovery effect with a single dose. Anti-cancer drugs are leading research and development of advanced biopharmaceuticals. Cancer diseases have a large number of unmet demand and indications with fewer patients with symptoms than the stage of disease development. Professor Kim said advanced bio drugs are a new alternative to the treatment of recurrent non-responsive incurable blood cancer, which currently has no cure. Kymriah (Tisagenleucel) using CAR-T cells was cited as an example. Professor Kim said Kymriah has been performing in the actual medical environment, with a total response rate of 53% in the follow-up analysis for about 40 months. Due to the characteristics of treatments that utilize human cells, there are many problems that need to be solved for commercialization, such as preparing a new system for medical institutions and establishing standards. In fact, CAR-T treatment in Korea requires permission, manpower, system, and standards from the management industry, and professional support such as infectious medicine, neurology, circulatory medicine, and critical patient medicine for comprehensive management after treatment. In particular, there are no advanced biopharmaceuticals called Marketing Authorization Under Exceptional Circumstances (MAEC). Looking at Kymriah's global status, Japan and Europe (France, Italy, Germany and Switzerland) recognized the benefit at the same time as the permit. Australia, Britain, Canada and Scotland, which have similar insurance benefit registration systems to Korea, applied their benefits after a quick review within a year of permission. Professor Kim believes that although Korea approved Kymriah on March 1, there is no insurance review program comparable to overseas countries. He said, "High-tech bio drugs are drugs that change the treatment paradigm. Patients waiting for Kymriah is less than 200 a year, and have only three to six months to wait for insurance benefit, and high-tech bio drugs need not only quick approval but also quick insurance registration."
- Company
- Huons has secured domestic rights to Sputnik Light
- by Lee, Seok-Jun Jul 11, 2021 07:03pm
- Huons said on the 7th that it has secured exclusive rights to domestic licenses and sales of Russia's one-shot vaccine Sputnik Light. Sputnik Light will be produced from Huons Global Consortium starting from second half of this year. It was developed by Gamaleya Research Institute of Epidemiology and Microbiology. It is a one-shot vaccine that was approved for use in Russia in May. It uses the same adenovirus as Sputnik V, a double inoculation method, as a vector (transmitter. However, only one type of vector (adenovirus type 26) needs to be inoculated once. The prevention effect is 79.4% and the immune system is known to last 3 to 4 months. Since the end of February, phase III has been underway for about 7,000 people in countries such as Russia, the United Arab Emirates and Ghana. Huons is considering Emergency Use Authorization for quick domestic approval.
- Policy
- Early supply of Pfizer in exchange for a vaccine with Israel
- by Kim, Jung-Ju Jul 11, 2021 07:01pm
- The Minister of Health and Welfare, Kwon Deok-chul signed a vaccine swap agreement today (6th), which will receive 700,000 pfizer vaccines from the Israeli government in July and return them sequentially from September to November. Recently, the Israeli government was looking for ways to make effective use of the vaccine, with some of the Pfizer vaccines (valid July 31st) expected to remain in use in July. The vaccine exchange between Korea and Israel will take place in consideration of the cold chain management base and the fact that the vaccination can be completed in a short period due to the high participation rate of vaccination. Since the announcement of the expiration date in Israel, the number of applicants for vaccination has increased and the exchange volume has been confirmed to be 700,000 after consulting for the first 800,000 vaccinations. Korea has secured enough supplies to introduce about 80 million batches in the third quarter, including about 10 million in July, but the vaccine exchange will speed up the vaccination process. The exchange of vaccines between South Korea and Israel has been largely attributed to the trust between the two countries through diplomatic efforts between South Korea and Israel. Since the launch of COVAX, a multilateral consultative body for responding to COVID-19, South Korea and Israel have held close informal consultations and discussed vaccine cooperation as similar countries. Recently, the two sides discussed ways to cooperate with vaccines, including the Israeli foreign minister's visit to Korea in May this year, and such efforts served as the basis for successful exchange of vaccines. Pfizer vaccine, which will be supplied early through the exchange of vaccines with Israel, are scheduled to arrive at Incheon International Airport at 7:15 a.m. on the 7th. This vaccine is already licensed in Belgium and is also being used in Israel for vaccination in July. The government plans to complete customs clearance immediately and conduct Emergency Use Authorization (EUA) so that it can be used quickly after the vaccine arrives. Afterwards, the MFDS will conduct its own quality inspection and domestic delivery procedures, and will be used for vaccination from the 13th. Pfizer vaccine (700,000 doses) to be supplied this time will be used for vaccination in addition to about 10 million doses originally scheduled for July. First of all, autonomous vaccination of local governments for Seoul and Gyeonggi will be implemented early from the 13th in order to stabilize quarantine in the Seoul metropolitan area. The government plans to supply Pfizer vaccines (340,000 people) to Seoul and Gyeonggi Province, where confirmed cases are concentrated, to stabilize the quarantine by short-term intensive vaccinations for job groups with high public contact (two weeks from the 13th). The local government will select the target groups, including jobs that have a high risk of spreading due to high contact with the public, and start vaccinating each vaccination center with a Pfizer vaccine on the 13th. The vaccination will be conducted at 43 vaccination centers in Seoul (about 200,000) and 51 vaccination centers in Gyeonggi Province (about 140,000). In addition, the government will expand the size of autonomous vaccinations for local governments, which will be implemented later this month. It plans to expand the autonomous vaccination of local governments to 800,000 people, which was originally planned to be 440,000 at the end of July, to reflect Israel's introduction. Autonomous vaccination of local governments will be carried out for 2 million people by August. The government will start vaccinating daycare centers, kindergarten, and elementary school first and second-grade faculty and care workers (380,000 people) among education and childcare workers originally scheduled to be vaccinated on July 28th (Tuesday). Advance reservations will take place from midnight on the 8th to 18th on the 10th, and those who are eligible for reservation will be informed how to book by text message by tomorrow. Other reservations and vaccinations for education and childcare workers (elementary and junior high school teachers, children's facilities, etc.) shall be carried out as originally planned. Since then, the government will return Pfizer vaccine received from Israel sequentially from September to November, when much of the vaccination was carried out in Korea. Kwon Deok-chul, head of the pan-government vaccine introduction TF team, explained, "This Korea-Israel vaccine exchange is a win-win strategy that can speed up vaccination during the summer vacation season by receiving vaccines earlier than scheduled for Korea." Jeong Eun-kyeong, the Commissioner of KDCA, said, "The importance of international vaccine cooperation is increasing at a time when vaccines are scarce around the world. "The vaccine exchange means early introduction of vaccines through international cooperation domestically, and internationally, it is an example of efficient use of vaccines." She said, "In particular, each country needs a vaccine at a different time, and the exchange of vaccines between Korea and Israel is expected to serve as a model for revitalizing international cooperation. In the future, we will also provide vaccines first, considering the vaccine supply and vaccination situation, and actively review the vaccine exchange we receive when we need it, so that vaccines can be effectively received internationally."
- Policy
- Bayer applies for approval of ‘Finerenone’ in Korea
- by Lee, Tak-Sun Jul 09, 2021 05:57am
- A groundbreaking new drug developed by Bayer is undergoing review for approval in Korea. The drug is known to inhibit disease progression in chronic kidney disease (CKD) patients with diabetes. According to industry sources on the 8th, Bayer applied for the approval of its ‘finerenone (Kerendia tab)’ to the Ministry of Food and Drug Safety in Korea. Finerenone, which was developed by Bayer, is considered to be a potential global blockbuster by the company. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that selectively acts on mineralocorticoid receptors to block harmful effects on the kidneys and the heart. It is reported to be particularly useful for patients with chronic kidney disease and diabetes. In a Phase III trial (FIDELIO-DKD) presented at the Annual Meeting held by the American Society of Nephrology in October last year, patients who took finerenone had an 18% lower risk of developing a composite of kidney failure, a sustained reduction of at least 40% in estimated glomerular filtration rate (eGFR) from baseline, or death from renal causes than those who took the placebo. The study enrolled approximately 5,700 patients with CKD and Type 2 Diabetes. Diabetic CKD patients have a risk for kidney damage and eventually kidney failure, despite currently available treatments. Bayer believes finerenone will be effective in delaying disease progression in this patient population. The drug has received a Priority Review designation by the U.S. FDA in January. With the designation, in the U.S., finerenone is expected to be approved within the second half of this year at the earliest. The drug is also under review by the EMA. Soon to face patent expiry for some of its products including Xarelto and Eylea, Bayer has expectations high for its new drugs, including finerenone.
- Company
- Researchers find COVID-19 Txs more effective than remdesivir
- by Kim, Jin-Gu Jul 09, 2021 05:56am
- A Korean research team of the Korea Advanced Institute of Science and Technology (KAIST) discovered new drug candidates for the treatment of COVID-19. Some of the candidates are expected to have a better effect than the currently approved remdesivir (product name: Veklury). On the 8th, the joint research team of Sang-yup Lee, Distinguished Professor of Chemical & Biomolecular Engineering at KAIST, and Dr. Seung-taek Kim, researcher of Institut Pasteur Korea (IPK)’s Zoonotic Virus Laboratory announced that they have discovered potential candidates for treating COVID-19 using their virtual screening technology. The team opted for a drug repurposing strategy using virtual screening. In other words, the team sought to find substances that may help treat COVID-19 among drugs with verified efficacy and safety. The researchers first built a virtual library on 6,218 drugs that are FDA-approved or in clinical trials, and then applied their newly developed virtual screening technology. The accuracy of the system was improved by adding structural similarity and interaction similarity analysis modules to the existing docking simulation-based virtual screening technology. Summary of the COVID-19 treatment development process using virtual drug screening technology (source: KAIST) Using the platform, the team selected 38 candidate compounds that inhibit the protease and RNA-dependent RNA polymerase needed for the replication and proliferation of the COVID-19 virus. Then, the efficacy of the candidates was verified by the Institut Pasteur Korea. Testing was conducted using a monkey’s kidney cells infected with COVID-19. Of the 38 candidates, 7 compounds showed antiviral activity. The 7 compounds that showed promise were further verified on human lung cells to be narrowed down to three: omipalisib, and tipifarnib, and emodin. Among these, omipalisib was found to have an antiviral activity that is over 200 times higher than that of remdesivir. Antiviral activity of tipifarnib was found to be similar to remdesivir. Omipalisib is currently being studied in a clinical trial as a treatment for cancer and pulmonary fibrosis. Tipifarnib is being studied in a clinical as a treatment for and progeria, and emodin, which is derived from plants, is being studied in a clinical trial as an anticancer drug. The research team is planning a preclinical trial on these 3 candidate substances. In the preclinical trial, the team aims to minimize toxicity and reach the effective concentration for treating COVID-19. Regarding the findings, Professor Sang-yup Lee said, ”With the research, we were able to prepare a base technology to promptly respond to new emerging viruses. We will continue our research to develop technologies applicable to new infectious viruses as well as variants of the coronavirus.”
- Company
- Jeil's anti-cancer drug business is doing well
- by Nho, Byung Chul Jul 08, 2021 05:59am
- It is noteworthy that Jeil is investing in expanding the lineup of anticancer drugs and research and development in related fields. Jeil, who entered his 33rd year of anti-cancer drug business, has a strategic relationship with Kyowa Kirin and Taiho in Japan and is making efforts to distribute original anti-cancer drugs. When the new anti-cancer drugs were introduced in the late 1980s, Jeil established a separate anti-cancer sales and marketing team to strengthen its professional capabilities and make communication between doctors and salespeople a top priority. The most likely anti-cancer drugs are Grasin300 PFS (Kyowa Kirin), Neulasta PFS(Kyowa Kirin), UFT(Taiho), Ts-1(Taiho), and Lonsurf (Taiho). The first anti-cancer drug introduced by Jeil was UFT(Tegafur·Uracil), which was first released in Korea in 1989. It is effective in relieving symptoms such as head and neck cancer, stomach cancer, rectal cancer, liver cancer, lung cancer, prostate cancer, uterine cervical cancer, and breast cancer, etc. UFT has capsule formulations and granules, which are usually administered three to six capsules a day, and the granules are taken in two to three doses of 300 to 600 mg. In 1993, Grasin300 PFS (Filgrastim) was released. The drug, which is a granulocyte colony-stimulating factor (GCSF) preparation, has indications of neutrophilosis, bone marrow dysplasia, regenerative anemia, congenital and idiopathic neutrophilia (HIV) infections. In 2004, the company launched a treatment called Ts-1(Gimeracil, Oteracil Potassium,Tegafur) for stomach, head and neck cancer, pancreatic cancer, and non-small cell lung cancer, providing a variety of treatment options for domestic patients. In 2014, it released Neulasta (Pegfilgrastim), the second generation G-CSF and co-sold it in Korea with Kyowa Kirin. Last year, Lonsurf (Tipiracil+Trifluridine) was introduced to provide new options for colon cancer treatment, and has continued its long sales experience in the domestic anticancer drug market. Lonsurf passed DC of 50 hospitals nationwide, including Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, and Severance Hospital in the first year of its launch. Based on UBIST, it ranks first in sales in the field of oral anticancer drugs newly approved in 2020, and is recognized for its efficacy. Lonsurf is expanding its share of the colon cancer market using a specialised sales network. Attention is also focusing on Onconic therapeutics, which was established last year to improve its position in the anti-cancer drug R&D field. Bio company Onconic therapeutics is a subsidiary 100% invested by Jeil and is expected to grow as an organization focused on the development of immune and targeted anti-cancer drugs. A year after its establishment, the company announced the results of Phase 1 for PARP (Poly ADP-ribose Polymerase) and JPI-547 at ASCO, drawing attention from Big Pharma. Phase I of the clinical trial evaluated the medicinal efficacy, safety of JPI-547 in patients with terminal solid cancer, according to Lim Seok-ah, a professor of hemato-oncology at Seoul National University Hospital, announced at the poster session. It is encouraging to identify the potential as a new treatment for ovarian cancer that does not respond to existing PARP treatments. Based on the results of this Effects are expected in HRD and PARP inhibitor resistant patients, including BRCA. "Based on the 30-year history of introducing anti-cancer drugs, we are continuously expanding our specialized sales network in related fields." said a representative of Jeil. "We will strengthen the pipeline of new items and improve our long-term research and development capabilities in the anticancer drugs market through open collaboration with Onconic Therapheutics."
- InterView
- Takeda, “Alunbrig improved both OS and QoL”
- by Jul 08, 2021 05:58am
- Medical Science Liaisons (MSLs) in Medical Affairs of pharmaceutical companies act as a ‘bridge’ between healthcare professionals and companies. They gather the unmet needs of HCPs and establish strategies for new drugs to address such needs. MSLs also deliver academic data and expertise based on clinical grounds in compliance with local regulations to HCPs, patients, and internal employees. Competition has been fierce in the non-small cell lung cancer treatment market, particularly the ALK targeted therapy market, with the introduction of various new drugs. The market is moving on from the one-and-only 1st generation treatment, Pfizer’s ‘Xalkori,’ to 2nd generation products. By order of entry, three 2nd gen products - Novartis’s ‘Zykadia (ceritinib),’ Roche’s ‘Alecensa (alectinib),’ and Takeda Pharmaceutical’s ‘Alunbrig (brigatinib)’ – have entered the market. Among these, Roche and Takeda’s products are in the fiercest competition. The role and responsibility of MSLs in charge of these products have also increased. Dailypharm met with Bokyung Kim, MSL at Takeda Pharmaceuticals Korea’s to hear about the ALK-positive NSCLC treatment market, its unmet needs, and the role and strategy of Alunbrig in this market. Bokyung Kim, MSL at Takeda Pharmaceuticals Korea -Could you give us a brief introduction about yourself and your role in Medical Affairs of Takeda Pharmaceuticals Korea? = SInce entering Takeda Pharmaceuticals Korea as an MSL in October last year, I have been in charge of Alunbrig for 9 months. I meet with healthcare professionals to identify the unmet needs in the field to establish strategies based on the demand. In the company, I discuss with various business divisions to set the direction for Alunbrig and prepare the necessary medical grounds so that our drug can contribute to resolving the unmet needs in the field. In the past, the Medical Affairs division mainly performed tasks to support other business divisions in the company, however, perception of the role of our department has started to change around 10 years ago. Medical Affairs now develops core strategies for new drugs, serving as a bridge between various business units as well as research and development. Also, the unit provides academic data and expertise to internal and external stakeholders in an objective and fair manner in compliance with the local code of medical ethics and regulations and provides academic advice. -At the time Alunbrig was introduced to Korea, other ALK-targeted therapies were already in the domestic market. Were there any difficulties due to this late entry? =Other treatments that were released before Alunbrig have brought treatment benefits to patients, however, unmet needs still existed in various areas, ranging from treatment effect, adverse events, quality of life, to convenience in administration. I believed that the introduction of Alunbrig could bring new treatment benefits that existing treatments were unable to provide. -What unmet need still remains due to characteristics of ALK-positive NSCLC in Korea? =ALK mutation occurs in around 4-5% of all NSCLC patients and occurs more commonly in women and Asian patients. Also, it is found more frequently in non-smokers compared to other NSCLCs and affects a relatively younger population in their 50s to 60s. Therefore, in addition to data on survival such as progression-free survival (PFS), other factors such as tolerance, medication adherence, and quality of life should also need to be considered collectively. The biggest unmet need in the treatment of ALK-positive NSCLC lies in brain metastasis and tolerance. This patient population has a higher risk of brain metastasis than other lung cancer patients. How long a drug can delay brain metastasis, and how effective the drug is in patients with brain metastasis must be considered. Also, people may have developed tolerance to TKI targeted drugs, therefore, how effective the drug is in such a population is also an important consideration. -With Alunbrig approved for insurance benefit in April as a 1st-line therapy, all ALK-targeted drugs introduced to Korea are now available with reimbursement from 1st line. What strengths does Alunbrig have over other ALK-targeted therapies with regards to its mechanism of action? How effective was the drug in patients with brain metastasis in clinical trials? =Unlike other existing treatments, Alunbrig was developed into a unique U-shaped platform. This structural design allows the drug to bind more strongly to the ATP attachment site that is used as an energy source when activating the ALK gene. In a preclinical trial, the drug selectively bound to ALK mutant variants to act stably in the body. Furthermore, Alunbrig demonstrated superior progression-free survival (PFS) and improved health-related quality of life (QoL) versus Xalkori, the existing first-line treatment option, in the Phase III ALTA-1L trial. In particular, in the second interim analysis, Alunbrig demonstrated superior clinical efficacy over Xalkori in the first-line setting regardless of brain metastasis in all ALK-positive NSCLC patients. Also, Alunbrig demonstrated a differentiated PFS improvement compared to Xalkori from early on in patients with brain metastasis that are difficult to treat. In addition, Alunbrig significantly reduced HR compared to Xalkori, to 0.25. So far, the data presented from the ALTA-1L trial only covers up to a two-year follow-up study by June 28th of 2019. We expect to see longer survival data when the final results are released soon. -Compared to other drugs that conducted investigator-assessed trials, the ALTA-1L trial was designed closer to the real world with BIRC-assessed endpoints. Why did the study choose to use BRIC-assessed results, which would have brought out more conservative results? =According to FDA guidelines, review from an independent evaluation committee can minimize bias. This is not essential in randomized, blinded clinical trials, however, as chemotherapy is often the standard treatment in cancer treatment, comparing this with oral anticancer drugs in a blinded trial is realistically not possible. This is why the trials are designed as open-label trials, in which case, BIRC assessment is required. We used BIRC-assessed primary endpoints according to the guideline recommended by the FDA to increase the objectivity and fairness of our trial. -How does Alunbrig affect patients with regards to their quality of life? = ALK-positive NSCLC occurs commonly in the socially active 50s. Therefore, studies on Alunbrig assessed the improvement in quality of life in addition to the drug’s efficacy. Assessed with the representative tool used for quality of life in cancer patients, EORTC QLQ-C30, the Alunbrig arm maintained the quality of life without worsening for 26.7 months vs. Xalkori. Also, convenience in administration is also an important factor to consider in long-term treatment. Many studies on long-term treatment experience from chronic diseases among others have shown that convenience in administration is very important for the quality of life and prognosis of patients. Alunbrig’s 1 tablet once daily administration is expected to contribute to the improvement of quality of life in these patients. *Dose and schedule of first-generation Xalkori is 1 tablet taken twice daily. Zykadia is taken in 3 capsules once daily, and Alecensa is taken in 4 capsules twice daily. -How was Alunbrig received in the field after being approved for reimbursement as first-line? Some have said that Alunbrig and Alecensa have similar efficacy in patients with brain metastasis. What is your view on this? =Alunbrig was positively reviewed by HCPs since being reimbursed as second-line treatment due to its good treatment effect in patients. With its reimbursement expanded in April, doctors have highly rated the drug as a new treatment opportunity for patients with an unmet need and for those who saw unsatisfactory effects from existing first-line therapies. Expectations were high as Alunbrig had shown high clinical effects in patients, but they were also highly satisfied in terms of convenience in administration. Also, the company’s efforts to promptly approve and reimburse Alunbrig in Korea as soon as it was approved as a first-line in the U.S. were positively received. Alunbrig and Alecensa have both shown better effects than Xalkori in clinical trials on patients with brain metastasis. We cannot directly compare the two drugs due to a lack of head-to-head study, however, patients should consider various aspects in addition to treatment effect, such as tolerance and convenience in administration when selecting their treatment. -Some patients hesitate using Alunbrig due to its pneumonia adverse reaction. =In the field, clinical practitioners have deemed that the symptoms after administering Alunbrig were similar to pneumonia, but is an EOPE (Early-Onset Pulmonary Events) that occurs temporarily. In some patients, symptoms similar to pneumonia may appear temporarily, but when the symptom is resolved early on, the symptom has the characteristic of not occurring again during the period of administration. Also, clinical experts in Korea have also said that EOPE symptoms are reversible adverse reactions that are fully manageable and can be quickly recovered.
- Company
- Chong Kun Dang loses 1st substance patient suit on ‘Xarelto
- by Kim, Jin-Gu Jul 08, 2021 05:58am
- Pic. of Xarelto Chong Kun Dang has lost its first trial targeting the substance patent of Bayer’s new oral anticoagulant (NOAC) ‘Xarelto(rivaroxaban).’ Whether Chong Kun Dang will modify its strategy to preoccupy the market through a release of its generic before substance patent expiry due to this ruling is gaining attention. On the 6th, the Intellectual Property Trial and Appeal Board (IPTAB) has ruled in favor of the original manufacturer Bayer, in a trial to confirm the passive scope of rights for Xarelto’s substance patent that was filed by Chong Kun Dang. Chong Kun Dang had solely challenged Xarelto’s substance patent in December last year. This was interpreted as a strategy made to overtake SK Chemicals and Hanmi Pharmaceutical that is currently leading the Xarelto generic market. SK Chemicals and Hanmi Pharmaceutical were the first to succeed in avoiding Xarelto’s formulation patent. The two companies finally won in December last year after the case went up to the Supreme Court, and secured exclusive marketing approval for Xarelto's 2.5mg formulation. However, both companies were unable to overcome the substance patent, and are unable to release the generic version until Xarelto’s substance patent expires in October this year. Chong Kun Dang made the bid for victory by challenging Xarelto’s substance patent. Then, in May, the company released its Xarelto generic 'Riroxia Tab.' 15mg and 20mg' in the market, before Xarelto’s substance patent expires. This was an attempt to preoccupy the market alone by avoiding the substance patent. Chong Kun Dang’s bold attempt was considered a risky game - if the company wins the case, the early release of its generic will not have constituted a patent infringement, but if it oses, it could bring serious repercussions from patent infringement. However, Chong Kun Dang lost the first trial. Based on the current situation, it has been analyzed that Chong Kun Dang's risky attempt is highly likely to fail and that Chong Kun Dang will have to bear the burden of patent infringement. For now, Chong Kun Dang is highly likely to appeal the case, as the higher courts may decide otherwise. Some industry officials also believe that even if Chong Kun Dang loses in the end, the end results will not be bad in terms of profit or loss. An official explained, “From Chong Kun Dang’s view, the profit gained by preoccupying the market while the patent suit is reviewed by higher courts may be greater than the compensation for damages that the company will owe to Bayer from the patent infringement."
- Company
- GC Pharma, the most likely company to produce Covivak
- by Nho, Byung Chul Jul 08, 2021 05:58am
- Chumakov Institute recently visited Andong Animal Cell Verification Support Center. Russia's Covivak is likely to be produced in domestic CMOs. According to industries, MPC, which is a South Korean corporation to introduce Covivak, recently signed a contract with Pharm Bio-tech, a Russian company that has rights to produce and publish in Russia, to acquire shares (37.5%). Among the domestic companies that invested in securing the stake, Wellbiotec, HumanN, and Nexton Bio became Pharm Bio-tech shareholders. MPC is also expected to establish a joint venture for Pharm Bio-tech and Covivak production, sales, and distribution in Korea to run vaccine businesses for ASEAN countries. The fact that it has become the second largest shareholder of Pharm Bio-tech, which has Covivak production and copyright, is interpreted as including technology transfer conditions, not just CMO production. It can also secure dividends based on sales performance of vaccine exports. This is in contrast to Samsung Biologics' production of Moderna COVID-19 vaccine CMO, which has yet to be confirmed whether or not the technology will be transferred. GC Pharma and Andong Animal Cell Demonstration Support Center are among the CMO and CDMO pharmaceutical bio companies that will produce Covivak. According to industry estimates, it takes about two months for the technology transfer of the Chumakov Institute researchers at the Russian Federal Academy of Sciences, and is likely to be completed by September at the latest. It is expected that production of Covivak will be possible around October. MPC, which is in charge of South Korea's Covivak business, said, "It is difficult to answer questions related to consignment production, consignment development and production." "However, all companies that are interacting agree that South Korea should become a global outpost for producing COVID-19 vaccines, and we will be able to produce positive results."
