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- 2025-12-24 06:33:40
- Policy
- Generic companies for Atozet are interested in contractors
- by Lee, Tak-Sun Sep 22, 2020 06:27am
- Atozet It is known that generic companies of the hyperlipidemia complex Atozet(Atorvastatin-Ezetimibe, Chong Kun Dang) will sign a consignment contract with Chong Kun Dang today (22nd). Generic companies are paying attention to the number of final contractors and scrutinizing their strengths and weaknesses. According to the industry on the 21st, Chong Kun Dang requested that the contract be revealed by the 18th after holding a consignment meeting on the 16th. And it is reported that the final contract will be made on the 22nd. Chong Kun Dang is recruiting 21 consignment companies. However, generic companies seem to be struggling until the last minute because the number of companies may decrease at the time of the final contract. However, most of them are expected to proceed with the contract. The reason they are interested in the number of companies is that the price of drugs varies depending on the number. In the new cascading drug price system, they can get high prices up to 20 items or less. Drug prices drop from 21 in the order of listing. However, if only 17 companies participate in the entrustment, A total of 19 items will be listed, including the original Atozet and Chong Kun Dang's incrementally modified drug(IMD). Therefore, the next generic also has an opportunity to receive high drug prices. The company entrusted with the first generic company, which is listed after the bioequivalence test, is also licensed at the same time, so it can receive high drug prices. The industry expects that consignees such as Dongkoo Bio&Pharma will enter the market by applying for permission after the PMS expires in January next year. Even if the entry order is late, it is an opinion that if the drug price is the same as that of Chong Kun Dang, it is not bad to belong to the generic group that goes through bioequivalence test. This is because the commissioned production cost of generic group, which had bioequivalence test, is lower. Due to such a complex formula, various theories are arising in the industry, such as a dual contract between Chong Kun Dang and Dongkoo Bio&Pharma. However, no content has been confirmed yet. The reason why it is so difficult to decide on generics for Atozet is that the cascade drug prices system, which has been in force since last July, are acting as a final blow. According to this system, up to 20 items in the order of listing will receive 53.55% of the drug price compared to the original if the conditions such as bioequivalence test and the use of DMF are met. However, starting from 21 generics, the order of approval became important as drug prices were calculated at 85% of the lowest price. Generic for Atozet that have been tested for bioequivalence can apply for permission in time for the expiration of PMS in January next year. However, Chong Kun Dang product that has undergone clinical trial is not generic, but is a drug for data-based re-evaluation, so it is expecting final approval in October. Chong Kun Dang is conducting a commissioned generics consignment production project that recruits consignors through grant (data sharing) and can enter more quickly than generics. Chong Kun Dang's products and delegated generics receive preferential drug prices over generics that have been tested for bioequivalence because they are listed in a faster order.
- Policy
- ORR 100%, Phase III of Lazertinib combination was approved
- by Lee, Tak-Sun Sep 22, 2020 06:26am
- The clinical trial of Lazertinib-Amivantamab, which was released by Janssen at the European Society for Medical Oncology (ESMO) on the 20th, is also being conducted in Korea. As a result of this interim study, the response rate (ORR) was 100%, raising expectations as a treatment for non-small cell lung cancer that threatens Tagrisso. Lazertinib is a new drug developed by Yuhan in Korea and exported to Janssen, a multinational pharmaceutical company. On the 21st, the MFDS approved a multinational phase III clinical trial for the combination of 'Lazertinib (JNJ-73841937)' and Amivantamab submitted by Janssen Korea. Lazertinib is a 3rd generation tyrosine kinase inhibitor (TKI) candidate, and Amivantamab is a bispecific antibody targeting EGFR-MET. This trial is the primary treatment for clinical trial subjects with local advanced or metastatic non-small cell lung cancer with EGFR mutations. Osimertinib, generic for Tagrisso versus Lazertinib compared to the combination therapy of Amivantamab and Lazertinib. This is a phase III, randomized clinical trial. 8 were domestic patients of the total 120 subjects. The examination will be conducted at Seoul National University Bundang Hospital, Samsung Medical Center, Seoul National University Hospital, and Shinchon Severance Hospital. Earlier, Janssen revealed the results of an interim analysis of the clinical trial of combination of Lazertinib-Amivantamab at the ESMO 2020 online meeting on the 20th at local time. According to the published contents, the combination therapy of 'Lazertinib-Amivantamab showed a high response rate in the patient group (45 patients) among the non-small cell lung cancer patients with EGFR exon 19 defect or L858R mutation, a group of patients without prior treatment experience (20 patients) and 3rd generation TKI 'Tagrisso' (Osimertinib) showed recurrence after taking. For patients without prior treatment experience, such as EGFR-targeted anticancer drugs, tumors in all 20 patients reduced and the objective response rate (ORR) was 100% (95% CI, 83-100) when evaluated at 7 months (median, range 3-19 months) after drug treatment. In addition, among patients who showed recurrence after administration of Tagrisso, the tumor size decreased in 16 patients. According to the clinical results, Lazertinib-Osimertinib is expected to be the next treatment for patients who are resistant to Tagrisso and as a first-line treatment.
- Policy
- Goal of generic for Atozet is to be approved in next January
- by Lee, Tak-Sun Sep 22, 2020 06:26am
- Atozet by MSDChong Kun Dang's consignment-produced hyperlipidemia combination drug 'Atozet (Atorvastatin-Ezetimibe) is known to have applied for approval this month and is aiming for approval in next January. In that Atozet’s PMS by MDS will expire in next January, it is faster to acquire product approval than generics that have undergone bioequivalence testing. Accordingly, it will be advantageous in terms of drug prices. Chong Kun Dang recently held a meeting with 21 outsourced companies and announced plans to proceed with item approval. Chong Kun Dang applied for approval of a drug with the same ingredients as Atojet, which had undergone its own clinical trial in April. This drug is expected to be approved as a drug for data-based re-evaluation in October. At the same time, it is expected to receive Atozet's remaining PMS (expired on January 22, 2021). Prior to this, Chong Kun Dang recruited 21 consignment companies for the drug. It is known that the selection of 21 companies was referred to in the order of sales of Atorvastatin formulations. It is reported that on the 16th, at the consignee meeting, the details of the item permission plan were announced. According to the industry, the consignment item plans to complete the application for permission this month and obtain an item approval in next January. After going through the insurance payment process, it will start selling from April. In this case, after the expiration of PMS in January, it will enter the market ahead of generics that apply for permission. In addition, the price of drugs is expected to be higher than those of generics depending on the cascade drug prices system. Chong Kun Dang's self-developed drug for data-based re-evaluation is expected to be approved in October. However, it is known that Chong Kun Dang will not release it first, but will sell it at the same time as the consignment companies. However, as Chong Kun Dang is currently jointly selling the original 'Atozet' with MSD, it is unclear whether Chong Kun Dang will directly release the generic. Accordingly, some say that it is highly likely to pass the sale of drugs developed after Chong Kun Dang to other companies. Atozet is a large-scale drug that recorded an outpatient prescription of ₩63 billion last year. With Chong Kun Dang's product development and PMS expiration, it is expected to turn into a competitive system from next year. However, since various interests such as drug price issues and co-promotion are complicated, it is expected that each company will have a great deal of effort in establishing strategies.
- Policy
- Acromegaly and Huntington’s disease drugs win approval
- by Lee, Tak-Sun Sep 21, 2020 06:12am
- The South Korean health authority granted licenses for Pfizer Pharmaceutical Korea and Teva Handok, respectively. Pfizer’s acromegaly treatment and Teva Handok’s Huntington’s disease treatment would be now accessible to the patients in need of treatment. The Ministry of Food and Drug Safety (MFDS) granted approval on Somavert (pegvisomant) by Pfizer Pharmaceutical Korea and Austedo (deutetrabenazine) by Teva Handok as of Sept. 16. Somavert injection is an incrementally modified drug with evidence submitted, whereas Austedo tablet is a novel drug. Somavert is used to treat adults with acromegaly and intolerance or resistance in normalizing insulin-like growth factor 1 (IGF-1) with somatostatin analogues, and who respond inadequately to surgery or radiation. Acromegaly is a hormonal disorder that enlarges hands, feet, forehead, and jaw as excessive level of growth hormone is excreted even after the growth plates have been closed. About 60 out of one million people are diagnosed with the rare diseases, and usually the diagnosis is made from forties. The main cause of the disorder is excess growth hormone produced by benign tumor in the pituitary gland. However, relevant studies have not found the cause of the tumor, yet. The recommended treatment is to remove the tumor in the pituitary gland with a surgery, but when the tumor is too big and cannot be removed completely, the patient has to receive radiation therapy and growth hormone-inhibiting medication simultaneously. But many of the patients do not respond well to growth hormone-inhibiting drug, so the demand for more fundamental treatment is high. The newly approved Somavert is a recombinant analogue of the human growth hormone, which blocks the growth hormone receptor and impedes signal transduction. During a clinical trial conducted with 112 acromegaly patients, Somavert demonstrated statistically significant improvement in overall symptoms and relevant indicators than the placebo. And approximately 93 percent of trial participants reached normalized IGH-1 level for 42.6 weeks. Also approved on the same day, Austedo is a new drug used to treat symptoms of Huntington’s chorea, a kind of inherited diseases. The Huntington’s disease is a rare progressive brain disorder caused by a mutated gene on chromosome 4. According to Health Insurance Review and Assessment (HIRA), there were 286 patients with Huntington’s disease reported in South Korea as of 2018. The most common symptom, also known as chorea, is abnormal motor behavior like sudden involuntary muscle spasms. Approximately 90 percent of the patients with Huntington’s disease show the symptom. Austedo conducted a clinical trial with 90 Huntington’s disease patients having chorea, but who can walk by themselves. The trial compared the drug against placebo and confirmed the drug’s statistically significant effect with the evaluation indicator score. The patient group taking Austedo reached 4.4 points, while the placebo group marked 1.9 points.
- Policy
- Cancer Fund Act is promoted
- by Lee, Jeong-Hwan Sep 21, 2020 06:12am
- A bill is being promoted to strengthen the guarantee of expensive anticancer drugs for cancer patients by establishing a cancer management fund. The goal is to improve the reality that patients are deprived of treatment opportunities due to delays in health insurance payments for innovative treatments such as immune anticancer drugs due to limitations in health insurance finances. On the 17th, Lee Jong Seong, a member of People Power Party, announced that he had proposed a partial amendment to the Cancer Control Act. The bill was submitted to the National Assembly on the 16th. He pointed out that if the national security of innovative anticancer drugs is not properly secured, treatment opportunities and options vary depending on the economic level. His opinion is that the priority of health insurance for anticancer drugs with high social demand should be raised, and separate financial support should be made if financial resources are insufficient. Accordingly, he proposed a bill to strengthen support for cancer patients and establish a cancer management fund as a source of funding for cancer screening, medical expenses, and cancer research and treatment projects. He said, "Protecting the lives and safety of the people is the basic duty of the government, and having a therapeutic safety net that meets the level of the Korean economy should be the core oriented value of health policy."
- Policy
- Sinopharm COVID-19 vaccine, not considered to be introduced
- by Kim, Jung-Ju Sep 18, 2020 06:29am
- Although China is in the midst of developing COVID-19 treatments and vaccines, the government said that it has no plans to import domestically unless the safety and efficacy of these products are secured. Far from being included in the plan to secure 30 million domestic patients, it means that domestic introduction itself is impossible. Kang-lip Kim, Vice Health Minister for the Central Disaster and Safety Countermeasure Headquarters for COVID-19, clarified this position through a Q&A briefing on the morning of the 16th. In order to accelerate the end of COVID-19, the government is currently approaching the 'two-track' method of supporting domestic development and securing quantities of foreign products in relation to treatments and vaccines. When it was introduced in Korea, it also planned to secure 30 million patients. China is also strengthening R&D for the development and export of domestic drugs and vaccines, among which, interest is emerging as to whether it is possible to introduce a vaccine developed by Sinopharm in Korea. Regarding this, Kim said, "Vaccines are much more difficult to verify for safety than other drugs. As we have not yet secured safety and efficacy data for vaccines being developed by Chinese pharmaceutical company Sinopharm, we will not review them in detail." Since there is no data on the safety and effectiveness of Sinopharm, it is not even reviewed whether it is introduced or not, and if the review is complete, it is possible to review domestic introduction or securing of quantity itself. He said, "although the securing of 30 million people has not yet been specifically structured, and it is not in the stage of confirming the so-called 'portfolio', various consultations are ongoing with pharmaceutical companies developing vaccines."
- Policy
- Jeil, started commercialization of JLP-1401
- by Lee, Tak-Sun Sep 17, 2020 06:29am
- Telmiduo Plus by JeilJeil has begun commercializing a high blood pressure-hyperlipidemia three-drug, credit-quantity formulation. It is a formulation that combines Telmisartan-Amlodipine-Rosuvastatin, and is known as a new product of Telmiduo Plus, which Jeil is already launching. The MFDS approved the phase I clinical trial protocol of JLP-1401 submitted by Jeil on the 10th. In this clinical trial, the pharmacokinetic properties and safety of Telmisartan/Amlodipine and Rosuvastatin and JLP-1401 administration will be compared and evaluated in healthy adult volunteers. JLP-1401 is also the name of Telmiduo Plus, which was approved by Jeil in May 2018. Telmiduo Plus has three doses with Telmisartan-Amlodipine-Rosuvastatin dosages of '40/5/10mg', '80/10/20mg' and '80/5/10mg' respectively. Jeil directly develops and supplies contract production to Samjin, Unimed, Hana, and Myungmoon. However, Rosuvastatin 5mg is missing, which has been evaluated as being inferior in market competitiveness. Both Yuhan and Ildong, which produce the same generics, are releasing products containing Rosuvastatin 5mg. In addition, Rosuvastatin 5mg was analyzed that the rate of reaching the target LDL-C control treatment target was high at 83.3% for males and 92.9% for females, even in a study of 1,851 Korean patients. Accordingly, it seems that Jeil is developing an additional combination drug containing Rosuvastatin 5mg. This is because Twynsta 80.5mg, a combination of Telmisartan-Amlodipine, and Crestor 5mg, containing Rosuvastatin are used as reference drugs for this clinical trial. When new products are completed, it is expected that market competitiveness will improve and production will increase. A total of 40 products of Telmisartan-Amlodipine-Rosuvastatin were approved. According to UVIST, in the first half of this year, Ildong's Telostop Plus recorded about ₩1.6 billion, Yuhan's Duowell A about ₩900 million, and Jeil's Telmiduo Plus about ₩800 million.
- Policy
- KDCA “All hands on deck to seek COVID-19 vaccine"
- by Kim, Jung-Ju Sep 16, 2020 06:25am
- The first director of Korea Disease Control and Prevention Agency (KDCA) Jeong Eun-kyeong stated the government agency would provide all possible support for seeking vaccine and treatment to completely overcome the COVID-19 crisis. Also, she added the rare disease designation and R&D for disease testing and treatment would be expanded as well. On Sept. 14, Director Jeong gave a celebratory address at the KDCA opening ceremony and vowed to fight against COVID-19 along with the people of South Korea. The opening of KDCA was supposed to be on Saturday Sept. 12 according to the revised legislation, but instead the agency was officially opened on Monday. Regarding the agency’s status elevation, Director Jeong expressed her commitment to serve the responsibility, as the change started with “the people’s grave wish and the government’s determination to overcome the COVID-19 as soon as possible, and to proactively prepare and thoroughly respond against such infectious diseases.” Moreover, Director Jeong stated the agency’s key goals—securing central and regional epidemiologic response and capability, taking responsibility as a comprehensive infectious disease control agency, reinforcing response against health risk caused by environmental changes, establishing aging society-related chronic and rare disease prevention program, strengthening future medicine R&D and personalized disease R&D in Korea National Institute of Health (NIH). Specifically, the director said COVID-19 is a barrier that must be overcome, and that the agency is putting the best effort to support the development of relevant vaccine and treatment. Director Jeong stressed, “Aiming to find Korean-made treatment and vaccine, the agency would reinforce collaboration with relevant companies and research institutes to accelerate the development procedure,” but also “the agency is to secure overseas COVID-19 vaccine in development to execute vaccination program as planned.” Additionally, the director said, “The rare disease designation would continue to expand, and relevant supportive policy would be strengthened,” and “Related R&D to develop testing and treatment would also be expanded.” The director concluded the address by saying, “Although we are still stranded in the middle of the stormy sea, I will be with all of you until we reach the shore safely as a new captain of the ship called KDCA, and as another sailor in the ship.”
- Policy
- Crovalimab by Roche is conducting phase III in Korea
- by Lee, Tak-Sun Sep 15, 2020 06:27am
- Soliris sold by HandokSoliris (Eculizumab), which has recorded high sales as a treatment for paroxysmal nocturnal hemoglobinuria (PNH), a rare disease, is undergoing phase III clinical trial in Korea. It is Crovalimab, excavated by Chugai in Japan and developed by Roche. On the 11th, the MFDS approved a phase III IND for 'RO7112689' submitted by IQVIA Korea. RO7112689 is the name of the development of Crovalimab that Roche is developing. IQVIA, a global CRO, is expected to conduct phase III clinical trial of Crovalimab. It is a multinational clinical trial, and out of the total 250 subjects, 5 were recruited in Korea. This is a phase III trial to evaluate the efficacy and safety of Crovalimab versus Eculizumab in adult and adolescent subjects with paroxysmal nocturnal hemoglobinuria (PNH) and currently receiving complement inhibitor therapy. Eculizumab is generic for Soliris sold by Handok in Korea. Soliris is a large-scale drug that is sold to patients with PNH, recording annual sales of ₩43.8 billion (as of IQVIA 2019). There are few patients as a treatment for rare diseases, but it is generating high profits with expensive drugs of ₩5.13 million per bottle. Ultomiris, an upgraded version of this drug, received item approval in May. PNH is one of the rare blood diseases in which red blood cells are destroyed by complement, which is a part of the immune system. If not treated after diagnosis, 4 out of 10 people die within 5 years. It is known that there are about 200 patients in Korea. Soliris, which was introduced in Korea in 2012, is the only treatment for now. Crovalimab, which was approved for phase III clinical trial this time, is known to have a mechanism to inhibit the complement chain reaction by inhibiting the C5 protein like Soliris. Japan's Chugai derives the substance, and Roche is currently developing commercialization. Lately, generic biotech companies such as Samsung Bioepis are also drawing attention to the PHN market, such as developing a Soliris biosimilar.It is noteworthy whether a new drug will become a rival drug for Soliris.
- Policy
- Famvir licensed by Ildong is now manufactured locally
- by Lee, Tak-Sun Sep 15, 2020 06:26am
- Ildong Pharmaceutical is anticipating Famvir profit to improve as the drug licensed out by Novartis would be manufactured in South Korea. A shingles treatment Famvir is an original famciclovir drug that Novartis received approval to market in South Korea in year 2002. In 2018, Ildong Pharmaceutical acquired the sales rights over Famvir in South Korea, and signed a deal with Novartis to transfer relevant technology to directly manufacture and sell the drug locally. Since then, the Korean company has conducted a bioequivalence test and prepared local production of Famvir. According to Ministry of Food and Drug Safety (MFDS), Famvir 750 mg tablet and 250 mg tablet have been registered to be manufactured in Korea as of July 28 and Sept. 9, respectively. Previously, the drug was manufactured overseas and imported by Novartis. However, Ildong Pharmaceutical is not the actual manufacturer; Famvir 750 mg tablet and 250 mg tablet are respectively manufactured from JW Shinyak’s Pyeongtaek plant and Dong Wha Pharmaceutical’s Chungju plant. These plants also manufacture other generic drugs. The locally manufactured Famvir 750 mg tablet has changed its label and was distributed to vendors. But Famvir 250 mg tablet was just transferred to a local manufacturer, so the products from the Korean plant would be distributed around January next year. Although manufactured in Korea, Famvir is expected to maintain the high sales record as an original drug. According to IQVIA last year, the original drug generated 7.7 billion won and made the highest sales among the same substance drugs. In Korea alone, there are 125 famciclovir drugs in the market. And as the drug is now manufactured in Korea, Famvir is projected to generate even larger profits.
