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- 2026-05-20 07:16:30
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- COVID-19's budget is being delayed in the National Assembly
- by Nho, Byung Chul Jun 24, 2020 06:14am
- With the global spread of COVID-19, vaccines and treatments are urgently needed, and the government's promised support budget plan is not in progress. Unlike the fast and full support in developed countries, there is concern that the support may be delayed and the golden time to overcome COVID-19 may be missed. As of the 23rd, 15 domestic COVID-19 related vaccines and treatments are being conducted by pharmaceutical companies and research institutes in Korea. In addition to Remdesivir which is recommended for the treatment of COVID-19 by the central clinical committee for emerging disease control, anti-viral drugs, immunotherapeutics, and preventive vaccines, which have been developed in-house, have entered clinical trials. Even though the industry suffered from COVID-19 patient loss, there are many pipelines related to COVID-19 that have not yet entered clinical trials. The industry and research institutes are doing their best because they need to succeed in developing vaccines and therapeutics that can produce and supply their own products to prevent the spread of COVID-19 in Korea and prepare for the post COVID-19 era where new infectious diseases can occur. Countries around the world are removing various regulations for the rapid release of vaccines and treatments, and investing in R&D even in the economic crisis. First of all, the United States is running an ultra-high-speed project that cuts the expected vaccine development time by half from one to a year and a half. As the government invested about 10 billion dollars in the project, US President Trump has repeatedly expressed his willingness not to spare money for vaccine development. The ‘Global Cooperation in COVID-19 Vaccine Development’, which the European Union and about 40 countries participated in, said that it will raise approximately $8.2 billion in grants for research on therapeutics and vaccines. China is also developing vaccines aiming to be completed by the fall of this year at the Chinese Academy of Sciences to take the lead in COVID-19 vaccine. President Moon Jae-in visited the Institut Pasteur Korea in Seongnam, Gyeonggi-do in April, and pledged full support by saying, "Develop the best for the treatments and vaccines." It also suggested that the government can purchase and store sufficient amounts of money even if there is no economic or commercial value in the market, so that efforts and costs in development can be compensated. This was reflected in the supplementary budget to provide 111.5 billion won for full-cycle R&D such as 'pre-clinical, clinical, and global phase III' for the early commercialization of promising candidates for therapeutics and vaccines. There were also plans for subsidies for each stage of development, including ₩9 billion for phase I, ₩24 billion for phase II and ₩15 billion for phase III. If successful in the development of vaccines and treatments, it is also essential to build infrastructure such as production facilities for rapid supply, so the budget for vaccine and treatment production facilities and process management support has been raised to ₩10 billion. However, as mentioned earlier, the budget is not passed by the National Assembly, and the industry is nervous about it. Concerns are raised that it is also a matter of time before companies that are accelerating the development of vaccines and treatments are braking the driving force for R&D. There is no commitment to support production facilities that need to secure infrastructure quickly in line with the development of vaccines and treatments. An official from the pharmaceutical industry said, "The whole world is committed to the development of COVID-19 vaccines and treatments. In Korea, even the determined budget is tied to the National Assembly." "The decision of the National Assembly is urgent."
- Company
- Penmix in trial to evade patent on fat dissolving Belkyra
- by Nho, Byung Chul Jun 24, 2020 06:14am
- An injection CDMO Penmix (CEO Park Dongkyu) succeeded in evading patent on Allergan’s under-chin fat reducing injection Belkyra (desoxycholic acid). On June 19, Intellectual Property Trial and Appeal Board validated the negative confirmation of patent scope on Belkyra’s desoxycholic acid and other pharmaceutical substance based on the salt (to be expired on Aug. 23, 2031) as requested by Penmix. Belkyra is a first injection the U.S. Food and Drug Administration (FDA) approved to treat moderate-to-severe convexity or fullness associated with submental fat in adults, and it was introduced to the Korean market in 2017. With the latest decision, Penmix has passed the first threshold of patent evasion. And if the company wins the litigation on two divisional patents owned by Allergan, it would be able to apply for the first approval after Aug. 24, 2023 when Belkyra’s post-marketing surveillance (PMS) ends. Moreover, if the Korean company wins the Belkyra patent (‘mechanism of reducing fat and related pharmaceutical patent’) invalidation trial, currently ongoing in partnership with Daewoong Pharmaceutical, Pinmex would be able to release its generic product early on May 19, 2025 before the patent expires. At the moment, the Korean fat dissolving injection market does not have any effective option besides Belkyra. Penmix and Daewoong Pharmaceutical stated, “The Korean companies are developing both the Belkyra generic and new innovative fat dissolving injection to expand the related market in Korea.” The relevant industries are keeping a close eye on Penmix and Daewoong Pharmaceutical’s patent trial results as Allergan’s Belkyra owns the exclusive indication. Currently, Jurlique is handling the distribution of Belkyra.
- Policy
- Promote to fast track bill for innovative companies
- by Lee, Jeong-Hwan Jun 24, 2020 06:14am
- Legislation is being put in place to give special cases of 'fast tracks' that speed up the approval and review process for new drugs developed by innovative pharmaceutical companies. The goal is to revitalize new drug development, grow innovation, and create jobs. On the 22nd, Ki Dongmin, a member of Democratic Party of Korea announced on the 19th that he had initiated a partial amendment to the Special Act on the Promotion and Support of the Pharmaceutical Industry. Current law certifies pharmaceutical companies that invest in research and development of new drugs over a certain scale to foster the domestic pharmaceutical industry as innovative pharmaceutical companies. Ki Dongmin, a member of Democratic Party of Korea said, “Innovative pharmaceutical companies are receiving national R&D preferential treatment, tax support, and research facility support, but they are not enough to receive practical help in developing new drugs.” Also, he added that a bill is needed to introduce fast tracks to new drug licensing and review developed by innovative pharmaceutical companies.
- Policy
- Reimbursement cut on prescribing multiple low-dose Verzenio
- by Lee, Hye-Kyung Jun 24, 2020 06:13am
- The healthcare benefit would be cut for prescribing multiple unit of Lilly Korea’s Verzenio 50 mg, instead of 100 mg or 150 mg doses. Both of Verzenio’s low and high-dose tablets are priced at 49,587 won, and more reimbursement is paid out on prescribing two 50 mg tablets instead or one 100 mg tablet or prescribing three 50 mg tablets instead of one 150 mg tablet. Korea’s Health Insurance Review and Assessment Service (HIRA) disclosed the list of cost-effective dose prescription subject as of June 2020. The list issued on June 22 listed total 2,899 drugs including 2,488 oral regimen drugs and 411 injections subject to reimbursement cut for prescribing multiple unit of lower-dose. The deduction would be automatically calculated when reviewing DUR and healthcare reimbursement billing. The revised review procedure would be enforced from Aug. 1. The list of cost-effective dose prescription subject was amended according to the list of reimbursed drug and maximum pricing updated on May 22. The combination of following oral regimen dose are subject to DUR-based benefit cut; Danagen’s Clicid tablet (250 mg/ 500 mg) and Donetek (250 mg/ 500 mg), Daewoong Pharmaceutical’s Dimenpezil ODT (5 mg/ 10 mg) and Dimenpezil tablet (5 mg/ 10 mg), CTC Bio’s Remecept tablet (5 mg/ 10 mg), Handok’s Aricept Evess tablet (5 mg/ 10 mg) and Aricept tablet (5 mg/ 10 mg), Huons Medicare’s Hunepezil tablet (5 mg/ 10 mg), Myung In Pharmaceutical’s Esven SR tablet (50 mg/ 100 mg) and Zos tablet (1 mg, 2 mg, 3 mg) and The U Pharmaceuticals’ Epinaon tablet (10 mg/ 20 mg). Moreover, following combination of dose are subject to benefit cut when prescribing multiple units of low-dose; Kolmar Pharma’s Lansira capsule (15 mg/ 30 mg), Lilly Korea’s Verzenio (50 mg/ 100 mg/ 150 mg), and Han Lim Pharma’s Prenexa SR tablet (50 mg/ 100 mg).
- Company
- Patients with Ultracet don't get benefit for anticancer drug
- by Eo, Yun-Ho Jun 23, 2020 06:21am
- There have been cases that do not meet the intention of the original insurance benefit standard in the treatment of prostate cancer. Targeted anticancer drug options such as 'Zytiga (Abiraterone acetate)' and 'Xtandi (Enzalutamide)' currently exist in adult resistant castration resistant prostate cancer (mCRPC). Moreover, since last May, the coverage has been expanded through screening benefits (Copayment 30%) for both drugs. It is said that the reimbursement is recognized if no narcotic analgesics are used, looking at the criteria for mCRPC treatment, such as Xtandi and Zytiga. The point is not 'narcotics' but 'painless or mild'. It is intended to administer anti-cancer drugs to patients who are not severe enough to be prescribed narcotic analgesics. However, there are some medications used to manage pain in mild patients, such as Ultracet (AAP/Tramadol). Ultracet is not classified as a narcotic analgesic by the MFDS, but Tramadol in Ultracet is classified as narcotic. Ultracet is similar to the pain control effect of high-dose NSAIDs (non-steroidal anti-inflammatory drugs) in medical field, but has fewer side effects and is widely prescribed. The mCRPC patient was excluded from the benefits of anticancer drugs because they were prescribed a commonly used drug. Recently, there were cases of patients excluded from the benefits due to being prescribed Ultracet on the National Petition on Cheongwadae website. The patient was diagnosed with end-stage prostate cancer and had surgery in June 2017 with bone metastasis. Since then, his cancer has spread to the lungs, but his condition has improved as the oral anticancer drug is prescribed and the prostate specific antigen (PSA) level is maintained below 0.5. However, because of Ultracet prescribed in the past, he were notified that it was no longer possible to get reimbursed, so he stopped taking the medicine. Currently, his condition has worsened, with PSA levels increasing to 5.98. Seok-Ho Kang, Public Relations Director of the KUOS, said "Ultracet is a widely prescribed pain reliever for patients with mild pain. For those who cannot receive treatment due to unreasonable reimbursement standards, it is necessary to improve the standards that are more realistic and consistent with clinical evidence."
- Policy
- HIRA clarifies coverage standard of Imfinzi following CCRT
- by Lee, Hye-Kyung Jun 23, 2020 06:21am
- To receive healthcare reimbursement when using AstraZeneca’s immunotherapy Imfinzi (durvalumab), a patient has to receive platinum-based concurrent chemoradiotherapy (CRT). Affected patients should be aware that the reimbursement benefit would not be provided for using Imfinzi after using sequential CRT or induction chemotherapy. Korea’s Health Insurance Review and Assessment Service (HIRA) recently published answers to frequently asked questions related to the reimbursement listing standard. Imfinzi is indicated to treat patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) without progression after platinum-based concurrent CRT. The healthcare reimbursement on the treatment was approved and listed from Apr. 1, in case of a PD-L1 positive (expression rate 1%) patient with unresectable locally advanced (stage III) NSCLC, who is in stable disease without progression after two cycles of platinum-based concurrent CRT, using the treatment within 42 days after the concurrent CRT. The reimbursement is provided for 12 months (not granted for maximum 24 months), only if the beneficiary has not received immune checkpoint inhibitor treatment such as PD-1 inhibitor. Regarding the reimbursement standard, HIRA informed, “Administrating the drug within 42 days after the completion of concurrent CRT means ‘within 42 days since the last day of the CRT.’” The government agency also clarified the platinum-based concurrent CRT means platinum-based concurrent CRT for radical purpose. To pass the reimbursement standard, a patient should receive radiation therapy administering over 54 Gy dose of radiation, or take weekly regimen CRT for over four cycles. The healthcare reimbursement is not granted to a patient using Imfinzi after other alternative therapies like sequential CRT. However, when using Imfinzi after induction chemotherapy followed by concurrent CRT, the healthcare benefit is provided if the two therapies used a same type of chemotherapy.
- Company
- Immunotherapies tap on SCLC treatment area for more options
- by Eo, Yun-Ho Jun 23, 2020 06:21am
- One after another, immunotherapies are tapping into the unexplored small cell lung cancer (SCLC) treatment area. According to the pharmaceutical industry sources on June 20, AstraZeneca’s Imfinzi (duvalumab), following Tecentriq (atezolizumab) by Roche, has been indicated as a first-line treatment for SCLC by Korea’s Ministry of Food and Drug Safety (MFDS) Imfinzi’s SCLC indication was cleared in Korea for the third time in the world after the approval in Singapore and the U.S. SCLC was considered to be ‘hopeless’ for new drug as there was no treatment option other than chemotherapy for last two decades. The aggressive SCLC shows poor prognosis with five-year survival rate of just 6.5 percent, about a quarter of patients with non-small cell lung cancer. The Phase III CASPIAN study tested efficacy and safety of Imfinzi against existing standard of care in patients with SCLC from 22 countries around the world, who have not received any treatment. The study confirmed statistically significant improvement in overall survival (OS) in the arm receiving Imfinzi combined with etoposide and either carboplatin or cisplatin chemotherapy, compared to the control arm treated with six cycles of chemotherapy followed by optional Prophylactic Cranial Irradiation (PCI). The Imfinzi combination therapy reduced the risk of death by 27 percent against the standard of care, and demonstrated median OS of 13.0 months, which was 2.7 months longer than the standard of care. And other endpoints like progression free survival and objective response rate have indicated Imfinzi combination therapy shows enhanced efficacy against the standard of care. As for another immunotherapy Tecentriq, the Phase III IMpower133 study confirmed Tecentriq’s meaningful efficacy by comparing 403 patients with SCLC either treated with Tecentriq combined with chemotherapy (etoposide and ecarboplatin) or the chemotherapy alone. The study result found the patient group treated with Tecentriq combination therapy reached the medial OS of 12.3 months, whereas the chemotherapy alone reached 10.3 months. Compared to the control group, the Tecentriq combination group had 30 percent lower risk of death. Also 51.7 percent of the patients in Tecentriq combination group survived after a year, but only 38.2 percent of the chemotherapy only group survived after a year.
- Policy
- Minister Choi said, COVID-19 treatment may come out
- by Lee, Jeong-Hwan Jun 23, 2020 06:20am
- Choi Kiyoung, Minister of Science and ICT, said that as soon as possible, COVID-19 treatment could be developed within two months. Minister Choi said that the development of treatments through the ‘drug repositioning method’ to discover the effect of COVID-19 treatment of already-approved drugs has been revealed, not through the approval of new drugs through new clinical trials. However, vaccines is expected to require a relatively long time because it is impossible to apply the drug repositioning method and clinical trials are required. On the 19th, Minister Choi said on Kim Hyun-jung's News Show(CBS Radio). Minister Choi said "The Ministry of Science and ICT is collaborating with the MOHW and the KCDC. The Ministry of Science and Technology mainly conducts basic research on sources." Minister Choi explained that clinical trials take a long time, but the drug repositioning method can target drugs that have already been clinically developed, which can significantly speed up drug development and the drug repositioning is the use of a drug that has been previously approved for other uses as COVID-19 treatment." In particular, when asked about the timing of the development of COVID-19 treatment, he said "As soon as possible, the treatment may come out within 2 months, but it is not a medicine targeting COVID-19, but the effect may be reduced." It was diagnosed that the vaccine development time would require a lot of time compared to treatment. He said that vaccines are not able to reposition a drug, so it can take a very long time. Fortunately, many people around the world have researched and some vaccines are in clinical trials. It will be released in the first half of next year as soon as possible, and it is possible to come out in Korea in the second half of next year."
- Policy
- Generic for Daxas was applied
- by Lee, Tak-Sun Jun 23, 2020 06:20am
- Generic for Daxas (Roflumilast, AZ), which was approved in Korea, was first applied. Particularly, the generic that has been applied are noted because they also contain low doses (250 mcg). According to the MFDS on the 19th, Generics for DAXAS (Roflumilast), were applied for approval as of the 5th and notified to patent holder AstraZeneca. The generic includes 250 mcg dose, as well as 500 mcg dose, which are the same as Daxas. Daxas 250 mcg is available abroad, but is not sold in Korea. The domestic patent right of Daxas is valid until February 19, 2023. In last March, Sama Pharmaceutical succeeded in evading the patent right through a passive judgment on the scope of rights. In last August, Sama was approved for a bioequivalence test that compares the bioequivalence between Daxas and its generic. However, it was not disclosed whether Sama applied for this license or not. Daxas is used as a maintenance therapy for severe chronic obstructive pulmonary disease with chronic bronchitis with a history of worsening symptoms. Adults over the age of 18 take one tablet a day, regardless of meals. As of last year's IQVIA, sales amounted to ₩1.5 billion. Generic for Daxas has not been approved in Korea so far.
- Company
- Daewoong wins first patent dispute in Belkyra after 2 years
- by Kim, Jin-Gu Jun 22, 2020 06:10am
- BelkyraDaewoong has passed the first gateway for the release of generic for Belkyra (Deoxycholic acid), which targets and eliminates fat cells under the chin. Daewoong won the patent dispute that has been leading for two years with Allergan. The IPT ( Intellectual Property Trial and Appeal Board) made a trial decision on the 19th at Daewoong Pharmaceutical's passive judgment on the scope of the right to claim Belkyra's formulation patent. The patent dispute related to Belkyra was triggered in March 2018 when Daewoong Pharmaceutical filed an invalidation trial on the formulation patent. Subsequently, in April, a trial to confirm the passive scope of rights was raised against the same patent. The dispute lasted more than two years. In this process, Allergan used a “time wasting” strategy through patent splitting. In January, two new patents were registered by removing some of them from existing patents. Daewoong Pharmaceutical also challenged each of the two split patents. Penmix, a subsidiary of Kuhnil Pharmaceutical, joined here. This trial is the conclusion of the passive judgment of the scope of rights raised in 2018. The result of the invalidation trial filed in the same year has not yet been announced. However, the Patent Judge has notified that the hearing will be closed in March, so it is expected that the result of this trial will be released soon. According to the industry, Daewoong Pharmaceutical analyzed that it raised a dispute with the aim of 'preemptive defense for the development of its own products' rather than 'early launching generics through patent evasion' from the beginning. Daewoong Pharmaceutical is currently developing a submandibular fat improvement injection under the name 'DWJ211'. Since March of last year, it has entered a phase III clinical trial in 150 patients at Konkuk University Hospital and Chung-Ang University Hospital. The indication is 'improvement of moderate and severe submandibular fat', which is the same as that of Belkyra. When development is finished, Allergan may file a patent infringement lawsuit. At this time, the trial is expected to be properly used for defense purposes. Even if the development of DJW211 is torn down, Daewoong Pharmaceutical will be able to release generics after August 24, 2023. Belkyra's patent expiration date is August 23, 2031, and the PMS expiration date is August 23, 2023. However, the generic release date is delayed if Allergan appeals. Belkyra is the only subcutaneous fat injection to be approved by the U.S. Food and the FDA. Belkyra’s indications include moderate to severe protrusions in adults or excessive submandibular fat improvement. It was released in Korea in early 2018. Belkyra contains Deoxycholic acid, a 100% chemical compound that is not derived from humans or animals. Injection of this substance subcutaneously irreversibly destroys the fat cell membrane and causes new collagen production at the treatment site.
