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- 2026-04-09 08:07:02
- Policy
- Myung-in & Hwan-in are launching Fycompa’s generics
- by Lee, Tak-Sun Sep 27, 2023 05:44am
- 에자이 . It is to launch early , and through this, the drug price was added 6% more than before. According to the industry on the 25th, Myungin and Hwanin will be reimbursed, respectively, on the 14th, when Fycompa material patent expires. It is launched on the market with a total of 6 dosages, and it is the first of the same ingredient in Korea. They succeeded in evading Fycompa patent (expected to expire on October 14, 2026) for an early release. Through this, they also received permission of priority for exclusivity and obtained exclusive rights in the late-after drug market from the 14th to July next year. During this period, the same formulations as the two products cannot be put on the market. The original has never adjusted the upper limit to 53.55% because there are no generics. The government grants an additional to these first generics. The typical generic is adjusted to 53.55% of the original highest price, while the first generic is priced at 59.5%. Fycompa was released in Korea in February 2016. It can be used as a single therapy for patients with partial epiluretic seizures in adolescents 12 years and older. According to last year's IQVIA, sales were 5 billion won, up 8.9% from the previous year.
- Policy
- MFDS grants EUA of Moderna’s adapted COVID-19 vaccine
- by Lee, Hye-Kyung Sep 27, 2023 05:44am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) approved the emergency use of Moderna’s monovalent vaccine ‘Spikevax Inj (andusomeran)’ that targets the COVID-19 Omicron subvariant (XBB 1.5) on September 26. The emergency use approval was granted per request by the Korea Disease Control and Prevention Agency to carry out its vaccination plan to prevent COVID-19 in the 2023-2024 winter season. The vaccine has already been approved in the United States and Europe. Previously, on September 12, the MFDS had also granted emergency use approval of Pfizer’s ‘Comirnaty Inj 01.mg/ml (monovalent vaccine that targets the COVID-19 Omicron subvariant (XBB1.5). The MFDS expects that the approved vaccines will help prepare for the winter pandemic and expressed that it will continue to make the best efforts to ensure that the public can receive the vaccine with peace of mind by reinforcing its safety management, including thorough quality control and collection of adverse events.
- Company
- Padcev can be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Sep 27, 2023 05:44am
- Padcev, the first targeted treatment for metastatic urothelial cancer, can now be prescribed at tertiary hospitals in Korea. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin) has passed the review of drug committees (DCs) at all of the ‘Big 5’ tertiary hospitals in Korea - the Samsung Medical Center, Seoul, Asan Medical Center, Seoul St.Mary’s Hospital, Sinchon Severance Hospital, with the Seoul National University Hospital being the last. Padcev is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4. It is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. In the trial, Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy group's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in risk of disease progression or death. The median progression-free survival (PFS) for Padcev was 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of the Department of Oncology at Seoul National University Hospital, explained, “Urothelial cancer is the most common type of bladder cancer that accounts for around 91% of all bladder cancers. 8 of 10 patients are over the age of 60, and due to its prevalence in the elderly and its frequent recurrence and metastasis, it is a fatal disease with a 5-year survival rate of around 5%. It had been considered one of those representative diseases with a large unmet need due to its limited treatment options and the low quality of life caused by accompanying urinary disorder symptoms such as hematuria, frequent urination, and residual urine." Kim added, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later-line therapies after using immunotherapy in the second-line due to the lack of a standard later-line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and therefore may open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”
- Policy
- Resolving Conflicts in Non-face-to-face Medical treatment
- by Lee, Jeong-Hwan Sep 27, 2023 05:44am
- The Ministry of Health and Welfare cited the legalization of non-face-to-face treatment through the revision of the Medical Act as a solution to resolve the conflict between the medical community and the medical community surrounding non-face-to-face-face treatment. In addition, the MOHW expressed his will to improve the non-face-to-face treatment pilot project as soon as possible, reflecting the on-site opinion that the scope of the first diagnosis is narrow, the criteria for re-examination is vague, and there is a gap between the medical field. On the 26th, the Ministry of Health and Welfare responded to the written question of Rep. Choi Young-hee, a member of the National Assembly Health and Welfare Committee. Rep. Choi Young-hee pointed out that it is necessary to institutionalize non-face-to-face treatment through the revision of the Medical Act based on the temporary non-face-to-face treatment results, but it is in a shutdown situation due to the non-infection of legalization. In response, the Ministry of Health and Welfare explained that the temporary non-face-to-face treatment conducted from the 2nd of 2020 to May of this year is only 0.3% of the total number of outpatient visits, and the pilot project carried out in June and July this year accounts for 0.2%, and explained that non-face-to-face-to-face treatment is being used as an auxiliary means of face-to-face treatment. The Ministry of Health and Welfare responded that revision of the law is essential to provide stable and predictable non-face-to-face treatment to the public, and it is urgent to deliberate on the revision of the medical law. In particular, the Ministry of Health and Welfare is that in order to resolve conflicts with the medical community and the pharmaceutical community, the National Assembly needs to reach a social agreement by revising the medical law. Furthermore, the Ministry of Health and Welfare has revealed a plan to objectively analyze and improve the current non-face-to-face treatment pilot project. The plan is to revise and improve the scope of the pilot project as soon as possible, reflecting the opinion that the scope of the initial diagnosis is too narrow and the criteria for re-examination is ambiguous, so there is a gap with the medical field. The Ministry of Health and Welfare said, "We will continue to prepare legislative and policy improvement measures for non-face-to-face treatment by reflecting the opinions of the field, evaluation and analysis results of pilot projects, discussions of advisory group, and satisfaction survey results. Legalization is essential to prevent illegal acts related to non-face-face-to-face treatment in advance and provide non-to-face treatment stably."
- Policy
- Why did the original Ninlaro voluntarily cut its price 34%
- by Lee, Tak-Sun Sep 27, 2023 05:44am
- The insurance ceiling price of Takeda Pharmaceuticals Korea’s multiple myeloma treatment ‘Ninlaro Cap’ will be discounted by 34% from October. 10% of the price cut is made due to the price-volume agreement system, but the company had voluntarily lowered the price significantly over the set 10%. It is rare for an original drug with no generic to reduce its insurance price ceiling by over 30%. Why did Takeda decide to make such an unexpected price cut? According to the industry on the 26th, from October 1, the insurance price ceiling of Ninlaro will be lowered by KRW 494,000 from the previous KRW 1,450,000 to KRW 956,000. This is a drastic reduction amounting to 34%. First, the maximum reduction rate for this drug was reduced by 10% through the price-volume agreement negotiations. It was reduced from KRW 1,450,000 to KRW 1,305,000. In addition, the company further lowered the insurance price ceiling to KRW 956,000 voluntarily. Regarding the price cut, Takeda Pharmaceuticals Korea, said, “In addition to the reduction due to the price-volume agreement negotiations, the change in the insurance price ceiling of Ninlaro Cap. is the result of the change in the company's internal policy. The company is pleased to be able to provide Ninlaro Cap. to patients with multiple myeloma in Korea at a reduced price." “All decisions within our organization are made in accordance with our code of conduct - Patient, Trust, Reputation, Business (PTRB) — which bring our values of Takeda-ism to life.” The nuance is that the price cut will provide economic benefits to patients. However, some analysts say that the reduction in the price ceiling will only change the list price, and there will be no actual change in the real price of the drug. Rather, the analysts expected that the company would benefit from tax reduction by lowering the list price. Ninlaro is reimbursed through an RSA (risk-sharing agreement) with the National Health Insurance Service. It is reimbursed through a refund-type RSA, which means that a certain percentage of the drug expenditure that exceeds the pre-agreed amount is refunded to the NHIS by the company. Refunds are made based on the actual price, not the list price (insurance price ceiling). Accordingly, the analysis is that if the actual price does not change, it will not affect product performance, health insurance expenditures, or the economic burden of patients. An industry official said, "The actual price may have gone down through the NHIS’s PVA system. But the voluntary cut seems to have only changed the upper limit of the list price." He added, "If the actual price remains the same, nothing much will change in the field.” He added, “However, by lowering the list price, you can benefit from tax savings during customs clearance. I understand that many companies that receive reimbursement through RSA are considering lowering their drug’s list price for tax benefits.”
- Policy
- Madopar triggers bioequivalence test verification requests
- by Lee, Hye-Kyung Sep 26, 2023 05:50am
- The demand has been rising for the government to verify the validity of bioequivalence tests conducted by generic versions of Madopar Tab (levodopa-benserazide), Roche Korea’s Parkinson's disease drug that had withdrawn from the domestic market. Opinions are being collected on the post ‘Regarding the validity of bioequivalence tests that serve as the standard for approving generic drugs’ that appeared as an open petition on the Petition24 website earlier this month. The opinion collection deadline is October 6. The petitioner, who described himself as a Parkinson's disease patient for 20 years, said, "Original drug manufacturers are withdrawing from Korea because of fake generic drugs. No matter how cheap the drugs are, we are in a situation where we have to put aside good drugs and take quack generic drugs.” The price of Madopar Tab was reduced with the introduction of generics in 2021, and Roche Korea voluntarily withdrew its marketing authorization on January 6 this year. The Ministry of Health and Welfare had been making efforts to supply the original in Korea, such as by extending the reimbursement term for Madopar that Roche voluntarily withdrew, from July 31 to December 31. However, Roche Korea submitted a written position on how it would be difficult to resupply the drug in Korea because the company has to obtain documents necessary for new domestic approval from its Italian manufacturing plant that produces Madopa Tab, and the manufacturing facility has been demanding a considerable price due as cost of restoring manufacturing facilities to produce the quantities for export. This is why patients have been demanding the Ministry of Food and Drug Safety to verify the validity of the bioequivalence tests that are conducted for the approval of generics. The petitioner said, "The withdrawal of original drugs and the introduction of generic drugs is a very natural phenomenon in some ways. I happily accepted this phenomenon and switched prescriptions to the relatively inexpensive generic drugs." "However, I physically feel the difference in effect when taking the medicine for a long time. Bioequivalence tests are designed on a logical and scientific basis, and many people have a great deal of trust in this bioequivalence test, I know that it is an internationally recognized test. But due to my personal experience, I can’t help but start to have doubts about its validity.” Therefore, the petitioner requested the government to create a bioequivalence test feasibility study team composed of experts to examine whether standards for generic drugs could be added to bioequivalence tests or whether new standards were needed and create an international standard for generic drugs that can be recognized around the world. However, the MFDS drew the line that the safety and effectiveness of generics that passed the bioequivalence test were equivalent to the original. An MFDS official emphasized, "In the case of generic drugs, bioequivalence tests that compare the drug with the original are required upon approval. When a generic drug demonstrates its bioequivalence to the original, its safety and efficacy are judged to be equivalent to the original drug. This is an internationally accommodated standard."
- Opinion
- [Reporter's view] Paid-in capital increase & bio ventures
- by Lee, Seok-Jun Sep 26, 2023 05:49am
- Bio ventures have recently begun to raise funds through paid-in capital increases allotted to shareholders as promised. This is a phenomenon that has recently emerged as the bio market is not doing well, making it difficult to attract investment from institutional investors such as VCs (venture capitals) or specific third parties. Shareholders express the current situation as a ‘crying train’. Even though there is a high possibility that the stock price will fall, it is because of the worry. Just looking at the past three to four months, there are numerous bio ventures that have completed or are in the process of capital increase. CJ Bioscience, PCL, SCM Life Science, Cellid, Voronoi, SD Biosensor, and Noul have completed the paid-in capital increase. MedPacto, Micobiomed, Lunit, EDGC, Kangstem, Vaxcell-bio, Medi-post, etc. are in progress. Among them, SD Biosensor (10.4 billion won), Lunit (201.9 billion won), Medi-post (120 billion won), MedPacto (115.9 billion won), and Vaxcell Bio (100.6 billion won) decided to increase paid-in capital on a large scale of more than 100 billion won. Honestly, it is difficult to identify bio ventures. This is because it is virtually impossible to judge technological capabilities. We only rely on the data disclosed by the company and judge its value by referring to technology exports, partners, research team history, etc. While watching the paid-in capital increase trend, we believe that it may be possible to separate bio ventures in other ways. For example, it is possible to understand valuation through ▲how often financing is raised, ▲how well the fund use plan matches reality, and ▲whether the financing plan announced through IR, etc. has been reversed. In addition, ▲how often management changes, ▲whether the securities report at the time of IPO is implemented, ▲the largest shareholder's participation in bequests, etc. can be objective factors. Of course, financing is also an important element of corporate management. However, the problem is that even as the years go by, more and more companies rely on financing rather than their own ability to survive. In a time where paid-in capital increases are rampant, why not try creating an opportunity for bio ventures to separate the pros and cons? There are not many factors that can determine a company's valuation as much as financing issues. This is especially true for bio ventures where liquidity is vital.
- Company
- Daewon’s Pelubi enters Indonesia with a KRW 4 bil deal
- by Chon, Seung-Hyun Sep 26, 2023 05:49am
- On the 25th, Daewon Pharmaceutical announced that its nonsteroidal anti-inflammatory drug, ‘Pelubi CR Tab’ has entered the Indonesian market. Pic of Pelubi series Daewon Pharmaceutical signed an exclusive export agreement with its Indonesian partner, PT. Interbat Pharmaceutical Industry, to export its finished Pelubi CR Tablet products to Indonesia. The 5-year deal is worth a total of USD 3 million (KRW 4 billion). Pelubi CR tablet is an improved version of Daewon’s new drug ‘Pelubi’ that offers improved convenience in administration. After being released in 2015 as an anti-inflammatory analgesic in 2012, its prescription area has been expanded, adding various indications such as post-traumatic pain and primary menstrual pain into the areas of chronic pain and acute pain. Daewon Pharmaceutical said, “Our Pelubi series has grown into a mega-brand product that posts annual sales of approximately KRW 40 billion, and has achieved the highest prescription volume among NSAIDs in Korea.” Indonesia is a country with a high demand for pharmaceuticals in Asia, accounting for approximately 27% of the entire ASEAN market. Its pharmaceutical market size amounts to approximately USD 3 billion (approximately KRW 4.022 trillion) in 2021. Pelubi was released in Russia early last year after 2 years of local clinical trials and on-site inspections. Daewon Pharmaceutical is planning to sign new export contracts with the Philippines and Mexico in H2, using its entry into the Russian and Indonesian markets as momentum. The company is waiting to complete product registration in Vietnam. Daewon Pharmaceutical plans to accelerate its expansion into overseas markets, focusing on the Eurasian Economic Union (EAEU) which includes Russia and Kazakhstan, as well as Central and South America, and Southeast Asia. In-Hwan Baek, CEO of Daewon Pharmaceutical, said, “As Pelubi was classified as a new drug in Indonesia, the export holds significance in introducing a Korean new drug to the foreign market. We expect this to significantly contribute to expanding our presence in the Asian and global market.”
- Company
- Luxturna can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 26, 2023 05:49am
- Luxturna, a one-shot retina treatment, can be prescribed at general hospitals. According to related industries, Luxturna, a treatment for Inherited Retinal Dystrophy, has passed the drug committee of medical institutions such as Seoul National University Hospital. Luxturna is currently in the process of registering for insurance benefits and is beginning to create a prescription environment. This drug passed HIRA on the 7th and is about to negotiate the price with NHIS. Discussions on reimbursement for Luxturna, which is an expensive drug and targets a very small number of patients, were difficult. An application for benefits was submitted in September 2021, but there has been no significant progress in the registration process and only recently produced results. Although it has passed the evaluation committee, it remains to be seen whether drug price negotiations can be concluded smoothly. Luxturna restores the function of the deficient or defective RPE65 gene, which is one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that fundamental treatment of the disease is possible. This drug was designated by the U.S. FDA as a Breakthrough Therapy in 2014, an Orphan Drug in 2016, and a Priority Review in 2017, and it also obtained expedited approval in 2017. Meanwhile, Luxturna proved its effectiveness through a phase 3 clinical trial conducted on patients with hereditary retinal disease in whom biallelic mutations in the RPE65 gene were confirmed. Clinical results showed that at one year of treatment, functional vision treated with Luxturna was statistically significantly improved compared to the control group that did not receive treatment. As a result of evaluating the average score of the Multi-Luminance Mobility Test as the primary endpoint at a year of treatment, the score change in the Luxturna treatment group was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
- Policy
- Pfizer’s Bosulif in pricing negotiations for reimb in KOR
- by Lee, Tak-Sun Sep 26, 2023 05:49am
- The reimbursement listing process for Pfizer’s Philadelphia chromosome-positive chronic myeloid leukemia (CML) treatment Bosulif (bosutinib) is gaining momentum. The drug has entered the drug pricing negotiation stage only 8 months after it received approval in January in Korea. As a late 2nd-gen Ph+ CML drug entrant to Korea, the drug is expected to contribute to increasing Pfizer's recognition in the domestic Ph+ CML treatment market. According to industry sources on the 25th, Pfizer accepted the results of the Drug Reimbursement Evaluation Committee (DREC) meeting that was held on the 7th. At the meeting, The efficacy and effect of Bosulif 100, 400, and 500mg were deemed adequate for reimbursement if the company accepts a price below the assessed price for Ph+ CML. DREC is understood to have presented a price lower than the weighted average of its alternative as other second-generation drugs, such as BMS Korea’s ‘Sprycel,’ Novartis’s ‘s ‘‘Tasigna,’ and Il-Yang Pharamceutical’s ‘Supect (ladotinib)’. In Korea, up to 4th generation Ph+ CML treatments have been released with the reimbursement listing of Novartis ‘Scemblix’ in July. As Pfizer accepted the conditions presented by DREC, Bosulif is expected to move on to the drug price negotiation stage. This is in 6 months since it the drug was first approved last January. At the HIRA's Cancer Disease Deliberation Committee that was held a month before DREC, the drug succeeded in setting reimbursement standards only for Ph+ CML as a second-line treatment. CDDC has decided to recognize the adequacy of the drug’s reimbursement only for Ph+ CML in the chronic phase (CP), accelerated phase (AP), and blast phase (BP) that shows resistance or intolerance to previous therapy. On the other hand, no reimbursement standard had been set for the treatment of newly diagnosed chronic phase Ph+ CML. Accordingly, Pfizer is expected to first list the drug as a second-line treatment as soon as possible, then move forward and expand its reimbursement as a first-line treatment. Given that the drug price negotiation deadline with the National Health Insurance Service is 60 days, there is a high possibility that the drug will be reimbursed within the year. If this happens, the drug will gain attention as a new drug that took less than one year from approval to reimbursement.
