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- 2026-05-18 17:10:27
- Policy
- Hanmi's HM15912 is approved for phase 2 in Korea
- by Lee, Tak-Sun Oct 12, 2021 05:50am
- Hanmi Pharmaceutical is developing a rare disease treatment aimed at the global market and is conducting phase 2 clinical trials in Korea. With HM15912 as a candidate for the treatment of Short bowel syndrome (SBS), clinical trials will be conducted at Samsung Medical Center. The MFDS approved Hanmi's phase 2 clinical plan for HM15912 on the 8th. This is a phase 2 clinical trial (DOLPHINS-2) to evaluate the safety, pharmacokinetics and pharmacokinetics of HM15912 in adult subjects with SBS-IF. A total of seven patients will participate in this test, of which two are domestic. Short bowl syndrome (SBS) is a disease in which the small intestine is naturally short in length or more than 60% of the small intestine is lost by surgical resection. This is known to cause rapid malnutrition due to food absorption. It is a rare disease in which less than five people occur per 100,000 people. Patients receive nutrients through blood vessels, which makes normal daily life difficult and can cause side effects such as liver failure and thrombosis in the long run, so treatment is urgent. Hanmi Pharmaceutical is developing this drug in the global market. In particular, Hanmi Pharmaceutical's own technology, the Labscovery platform, is being developed as a formulation drug administered once a month. Earlier this year, phase 2 clinical trials were approved by the U.S. FDA and began clinical trials in June. The U.S. FDA and the MFDS have designated this drug as a rare drug in the development stage to support rapid commercialization. If designated as a rare drug by the FDA, benefits such as tax reduction, exemption from the cost of applying for permission, and exclusive rights for seven years upon approval for the first time among products of the same affiliate will be granted. Few patients are suffering from rare disease treatments, but global pharmaceutical companies are also focusing on development due to high costs. Rare drugs with high effectiveness receive high value. If Hanmi Pharmaceutical proves its validity in phase 2 clinical trials, it is also expected that overseas big perm will buy it. Attention is focusing on whether South Korea and the U.S. will be able to reach the global stage through their own technology in the rare disease treatment market.
- Policy
- Gov “It was the experts’ decision to not list Kymriah”
- by Kim, Jung-Ju Oct 12, 2021 05:49am
- In response to NA’s criticism regarding the delayed reimbursement listing of Kymriah, the government has expressed its difficulties as the decision was a result of an expert assessment. Also, the government denied the claim that that insurance coverage is only being extended for mild diseases. This was the response Health and Welfare Minister Deok Cheol Kwon gave to the claims that were made by NA member Jong Sung Lee at the NA Health and Welfare Committee’s audit of the Ministry of Health and Welfare that was held on the 7th. Lee had previously pressed the government for the prompt listing of Kymriah, using Soliris in 2012 and Spinraza in 2019 as examples of how the government is passive in listing new drugs. Lee said, “A clinical trial had shown that Kymriah could increase the survival rate by 60%. It feels that the government is immersing itself in populist policies - those that benefit a large number of mild patients - and neglecting the small number of severely ill patients.” He continued, “How hard could it be for the government, which had once announced that it could spend 1 trillion won as phone bill support for the public, list one single drug for our young patients?” Minister Kwon immediately refuted Lee’s claim. Kwon said, “The claim that only the coverage for mild disease patients has increased during President Moon's administration is not true. The coverage rate of severe disease patients is currently over 70%. I believe there is a misunderstanding here. The government also believes that we should promptly provide insurance benefit for severely ill patients.” He explained that the decision on Kymriah was not made by the government and was a result of an expert assessment. “Kymriah is an ultra-high-priced drug, and is being reviewed by the experts.”
- Policy
- The MOHW expressed reluctance to Keytruda's primary benefit
- by Lee, Jeong-Hwan Oct 12, 2021 05:49am
- Minister Kwon Deok-cheol (photo = provided by the National AssemblyMinister of Health and Welfare Kwon Deok-cheol expressed reluctance to applying MSD immuno-cancer drug Keytruda as a primary treatment for lung cancer, citing enormous health insurance financial needs. On the 6th, Minister Kwon responded to a question from Kang Sun-woo (the Democratic Party of Korea) at the National Assembly Welfare Committee's parliamentary audit. He pointed out that when lung cancer was first treated with Keytruda, it was more effective in treating diseases than when used as a secondary treatment. He introduced that the U.S. NCC guidelines also recommend Keytruda as a priority in single and combined therapy. He criticized that unlike overseas countries such as the United States, Korea is applying benefits so that Keytruda can only be used as a secondary treatment in the event of a traditional chemotherapy failure, increasing the burden on patients. He said, "It costs 7 million won a month for lung cancer patients to spend Keytruda at their own expense from the first treatment. He said,"if it is administered every month, about 100 million won per year is needed. 52 countries around the world have already applied the primary benefit, and 31 OECD countries have also recognized the primary benefit." He then asked Minister Kwon Deok-cheol if he had any plans, such as a system that is registered first and then evaluated for Keytruda benefits or a separate cancer fund. Minister Kwon replied that the pre-registration & post-evaluation system is also under comprehensive review in consideration of the financial burden of health insurance and difficulties in managing drug prices. He explained, "If Keytruda, the current secondary treatment, is allowed as the primary treatment, it will affect huge health insurance finances, so there should be a (cost-effectiveness) evaluation." He said, "In the system, it becomes reasonably difficult to manage drug prices because the health insurance finance has to pay the drug price at the time of pre-registration." "We need to comprehensively review that," he added.
- Company
- SK Bioscience will also produce COVID-19 vaccines next year
- by Chon, Seung-Hyun Oct 12, 2021 05:49am
- At an agreement ceremony held in Brussels, Belgium on the 5th, SK Bioscience President Ahn Jae-yong (right side of the picture) and CEPI CEO Richard Hatcht are signing a contract to use the Andong L House facility SK Bioscience will also entrust production of COVID-19 vaccines from global pharmaceutical companies next year. SK Bioscience announced on the 5th that it has signed an extension contract for the use of Andong L House facilities with CEPI in Brussels, Belgium. It will extend the period of using some of the undiluted production facilities in Andong, which were signed in June last year and are about to expire at the end of this year, to the end of 2022 for the production of COVID-19 vaccines by CEPI-supported companies. The contract said that by the end of next year, three of SK Bioscience's facilities in L-house will be used first to entrust production of the COVID-19 vaccine developed by a company supported by CEPI. The two companies agreed to continue close cooperation to overcome the current pandemic situation and expand cooperation in research on various infectious diseases that have frequently occurred recently and the development of vaccines accordingly. SK Bioscience participated in the world's efforts to prevent the spread of COVID-19 infection and discussed "1 Euro" with only symbolic meaning as an initial down payment to maintain friendly cooperation with international organizations such as CEPI and COVAX facilities. CEPI has decided to continue to utilize SK Bioscience's facilities as a public goal to secure fair vaccine access by supplying additional COVID-19 vaccines around the world through the COVAX facility. COVAX facility currently plans to supply a total of 2 billion doses of COVID-19 vaccine to the world by the first quarter of next year. SK Bioscience plans to accelerate the development of its own COVID-19 vaccine, which is currently in phase 3 clinical trials, in close cooperation with CEPI. The COVID-19 vaccine candidate GBP510 jointly developed by SK Bioscience and Institute for Protein Design (IPD) and using GlaxoSmithKline's Pandemic Technology is currently in phase 3 clinical trials. CEPI cooperated with the Bill & Melinda Gates Foundation from the initial development stage of the GBP510 and provided SK Bioscience with up to USD 213.7 million in development funds. GBP510 was selected as the first target of the 2nd generation COVID-19 vaccine project operated by CEPI last year to support differentiated COVID-19 vaccine candidate materials. When GBP510 is commercialized, hundreds of millions of vaccinations will be supplied worldwide, including underdeveloped countries. SK Bioscience and CEPI are additionally discussing the development of GBP510 in preparation for variations and research on booster shots. "The additional facility use contract with SK will provide an opportunity to approach the promise of COVAX facilities to protect vulnerable populations through fair vaccine supply, while further strengthening the relationship between CEPI and COVAX facilities and South Korea," said Richard Hatchett, CEO of CEPI. Ahn Jae-yong, president of SK Bioscience, said, "The proven production system and technology shown by global companies during consignment production of the COVID-19 vaccine led to an extension contract with CEPI." Next year, we will secure and supply our own COVID-19 vaccine, which will serve as a hub for global vaccine supply, he said.
- Company
- Dupixent reimbursement in pediatric AD is being discussed
- by Eo, Yun-Ho Oct 08, 2021 05:57am
- Discussion on prescribing ‘Dupixent’ to pediatric patients with atopic dermatitis is now showing visible progress. According to industry sources, the National Health Insurance Service has started expert inquiries to start discussions on applying insurance benefits to the lower-dose (200mg) formulation of Sanofi-Aventis Korea’s Dupixent (dupilumab). This is 7 months since the company had applied for reimbursement in April. Accordingly, other processes including its deliberation date by the disease subcommittee, etc. are expected to be soon set. The lower-dose Dupixent was approved in Korea in adolescent patients aged 12 or older with severe atopic dermatitis who are less than 60kg. After an initial dose of 400mg, the patient is administered 200 mg every other week. Since then, Sanofi added the indication for treating pediatric patients aged 6 to 11 with severe atopic dermatitis for its low-dose formulation and then applied for its reimbursement listing. The health insurance benefit for Dupxient is approved for adult patients aged 18 or older with 3+ years of medical history with severe chronic atopic dermatitis that meets all three standards: ▲ unable to control symptoms even with first-line topical therapy for 4 or more weeks; ▲ cannot use systemic immunosuppressants due to no response or side effects despite 3 or more months of use; ▲ had an EASI (Eczema Severity Assessment Index) of 23 or higher before using Dupixent. This is for the 300mg dose. The efficacy and safety of 200mg Dupixent were verified through the LIBERTY AD ADOL clinical trial. 251 adolescent patients with severe atopic dermatitis patients who were treated with Dupixent 200mg and 300mg showed a 66% improvement in the size of lesion and severity at week 16, as well as clinically significant improvement in their quality of life index. 75% of the group that was administered Dupixent in combination with topical corticosteroids, achieved EASI 75 (EAST improvement of 75%) at week 16, demonstrating a more significant improvement compared to the 26.8% of the placebo group. Since Dupixent, other JAK inhibitors used for autoimmune diseases like rheumatoid arthritis have also been seeking to enter the atopic dermatitis treatment market. In June, Lilly Korea submitted a reimbursement application for ‘Olumiant (baricitinib),’ and Abbvie Korea has recently added an AD indication for its ‘Rinvoq (upadacitinib).’ Also, Pfizer applied for domestic approval of ‘Cibinqo (abrocitinib)’ recently.
- Company
- PARP inhibitor Zejula, which is partially covered
- by Oct 08, 2021 05:57am
- PARP inhibitor Zejula could be reimbursed as the primary maintenance therapy for ovarian cancer. However, it is pointed out that "regulatory agencies should change their perspectives" due to benefit standards. Kim Jaewon, professor of obstetrics and gynecology at Seoul National University Hospital, is taking Korea on the 7th. At the Zejula online meeting held by the restriction, he pointed out, "It is regrettable that only ovarian cancer patients with BRCA mutations have recognized primary maintenance benefits. This is in accordance with the stereotypes of regulators, and we need to change our perspective like in the United States." Earlier, the Health Insurance Review and Assessment Service recognized the clinical usefulness of primary maintenance therapy only for BRCA positive. Regulatory authorities believe that Zejula can be used regardless of the BRCA mutation, but the application of benefits is insufficient. Professor Kim Jaewon The underlying PRIMA clinical results showed that Zejula showed a median progression-free survival (mPFS) of at least twice as long as that of placebo groups in the entire patient group, regardless of BRCA mutation and covalent recombinant deficiency (HRd) (21.9 months vs. 10.4 months). The risk of disease progression and death also decreased by 57%. The effect was highest in the BRCA-positive patient group. The mPFS of BRCA-positive patients in the HRd patient group was 22.1 months in the Zejula-administered group and 10.9 months in the placebo group. However, even in the BRCA negative patient group, mPFS satisfies statistical significance to 19.6 months in the administration group and 8.2 months in the placebo group, allowing Zejula to extend the progression-free survival period regardless of the BRCA mutation. Jang Hyun-ah of Takeda Pharmaceutical Korea said, "In terms of PRIMA results, Zejula showed consistent treatment effects regardless of biomarkers, including patients in high-risk groups." She also explained, "We also confirmed that the dose can be adjusted and used according to the patient's condition, and that even if the capacity is low, there is no difference in effect and the safety profile improves." The reason for dissatisfaction with the disapproval of benefits in the BRCA negative group is that more than 80% of ovarian cancer patients do not have a BRCA mutation. Patients are suggesting expanding their salaries so that many people can take the first PARP inhibitor that can be used regardless of BRCA mutation. Professor Kim Jae-won also said, "There are quite a few patients who benefit from HRp, not HRd, without biomarker mutations." He said, "A similar thing happened in the United States five to six years ago, but the PARP inhibitor was accepted by changing the perspective to an advanced survival period according to the characteristics of ovarian cancer. "I think the government should cover all of them regardless of mutations with insurance benefits because many of them can be cured if they use drugs," he said. 제줄라 국내 허가사항과 급여 현황(자료: 한국다케다제약)
- Company
- Lynparza was approved for pancreatic cancer/ prostate cancer
- by Oct 08, 2021 05:56am
- PARP inhibitor "Lynparza (Olaparib)" has expanded its indications to pancreatic and prostate cancer. AstraZeneca Korea announced on the 7th that it has been approved by the MFDS for Lynparza's indications for pancreatic and prostate cancer. As a result, Lynparza can be used for ▲ maintenance therapy in adult patients with gBRCA mutated pancreatic cancer who have not undergone chemotherapy for at least 16 weeks after receiving 1st platinum-based chemotherapy and ▲ for treating adult patients with BRCA mutated metastatic castration-resistant prostate cancer who have previously progressed after treatment of new hormone treatments. The approval for pancreatic cancer and prostate cancer indications was based on clinical studies of POLO3 and PROfound4, respectively. In a POLO phase 3 study evaluating the efficacy of Lynparza maintenance therapy in pancreatic cancer patients with reproductive cell BRCA (gBRCA), the median progression-free survival period (PFS) of the Lynparza administration group was 7.4 months, nearly doubling compared to placebo (3.8 months). Approval for prostate cancer indications was based on the results of sub-analysis of patients with BRCA1/2 mutation in a PROFUND phase 3 study [3] in patients with HRR mutation metastatic castration resistant prostate cancer. In this study, Lynparza reduced the risk of disease progression and death by 78% in patients with BRCA1/2 mutation among the target patients, and the median radiological progression-free survival period (rPFS) was 9.8 months, showing improved results than enzalutamideAAbiraterone of 3.0 months. In addition, the median overall survival period (OS) of the enzalutamideAAbiraterone group was 14.4 months, while the Lynparza administered group recorded 20.1 months, lowering the risk of death by 37%. "Lynparza is the first ARP inhibitor to expand indications in two carcinomas, pancreatic cancer and prostate cancer, showing clinical usefulness in two carcinomas that had high incomplete demand," said Myung Jin, executive director of the anticancer drug division. In particular, metastatic pancreatic cancer and metastatic castration-resistant prostate cancer are all the more meaningful in that treatment options have been limited, he said.
- Policy
- Pfizer vaccines from Romania not transported in official box
- by Lee, Jeong-Hwan Oct 08, 2021 05:56am
- Criticism has been raised that the 1,053,000 doses of Pfizer’s COVID-19 vaccine that the government received from Romania last month were not stored in transport boxes that were officially authorized by its manufacturer, Pfizer. Pfizer’s vaccines require ultra-low-temperature storage for quality maintenance and should be stored in Pfizer’s custom shipping box that ensures cold chain storage. However, the criticism is that the government used private boxes, which could have compromised the quality of the vaccines. On the 7th, National Assembly member Jong Hean Baek of the People Power Party raised the issue based on the data submitted by the Korea Disease Control and Prevention Agency. According to the data, while transporting Pfizer's vaccines from Romania to Korea via Incheon airport in September, the Korean government used vaccine shipment boxes provided by a separate private transport company. The background is that the Romania government had returned Pfizer’s custom shipment back to Pfizer after directly purchasing the vaccines. Baek said that using private storage boxes for sensitive vaccines that should be transported in specially designed ultra-low-temperature storage containers is the issue. Although they look like regular delivery boxes, Pfizer’s custom boxes use new plastic material or polymeric compound-coated corrugated cardboard and are strong against moisture, and have excellent thermal insulation. Baek added that Pfizer meticulously packs its vaccines in custom boxes in its Belgium facility before shipping them to Europe. This is to maintain the ultra-low temperature required to ensure the quality of the vaccine, and the box is packed in two layers and filled with refrigerants in between. Baek added that in Korea, Pfizer Korea receives and the vaccines from the custom shipment boxes, takes out the vaccines, and returns the custom boxes to Belgium for reuse. In other words, Baek’s view is that the vaccines should have been shipped after obtaining Pfizer's custom shipment boxes to maintain the vaccines’ quality and warranty. As of the 5th, 4,031 cases of adverse events were reported after being vaccinated with the Pfizer vaccine provided by Romania. The government is investing in the causality of the events and said that the vaccines’ temperature has been well maintained in the course of bringing the vaccines to Korea. Baek said, “While conducting the casualty investigation for the Pfizer vaccines from Romania, the government should analyze the cause by looking specifically at whether the initial cold chain was compromised in any way. Also, the government should transparently disclose whether the manufacturer will warrant after-sale service for Romania’s vaccine quality issue.”
- Company
- Latecomer JAKi ‘Rinvoq’ now has the most indications
- by Oct 08, 2021 05:56am
- The latecomer JAK inhibitor, Abbvie’s ‘Rinvoq,’ is seeking to overturn the market landscape by greatly expanding its indications. Whether the drug can break the two-way lead battle between Xeljanz and Olumiant, is gaining attention. According to the Ministry of Food and Drug Safety, Abbvie’s ‘Rinvoq (upadacitinib)’ received additional approval for psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis indications. With the original rheumatoid arthritis indication, Abbvie’s drug is now approved for 4 indications in total. More specifically, Rinvoq is indicated for the treatment of adults and patients over the age of 12 with moderate to severe atopic dermatitis. In ankylosing spondylitis, Rinvoq can be used to treat adult patients who show inadequate responses to existing treatments. Also, in psoriatic arthritis, the drug can be used as monotherapy or combination therapy in patients who are intolerant or do not respond appropriately to disease-modifying anti-rheumatic drugs (DMARDs). In particular, the drug became the second JAK inhibitor after Olumiant to be approved for atopic dermatitis, a condition that has limited treatment options. Unlike Olumiant, which can only be used in adults, Rinvoq can also be used in adolescents aged 12 or older. With the addition of Rinvoq, biologic treatment options for atopic dermatitis have now increased to three in the market that used to be dominated by Sanofi Aventis’s ‘Dupixent.’ Abbvie has been actively targeting the atopic dermatitis treatment market, conducting a head-to-head trial between Rinvoq and Dupixent. In the Phase 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group. More recently, the patients’ eczema area was divided into 4 (head and neck, body, arm, leg) to assess the rate of EASI 75 response at week 16 in the areas. At EASI 76 at week 1 in all 4 areas was higher for Rinvoq, and lasted so until week 16. In other words, the study indicated that Rinvoq can relieve symptoms faster than Dupixent, regardless of the affected area. Rinvoq is a latecomer JAK inhibitor that was introduced in Korea in June last year. This is 2.6 years later than Olumiant and 6 years later than Xeljanz. During this period, Xeljanz had overtaken the market by expanding the area to rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and releasing an extended-release formulation. Then, Olumiant started to show strength in rheumatoid arthritis and divided the JAK inhibitor market into a two-way race. Also, Olumiant became the first to receive approval for atopic dermatitis, pioneering a new market. According to the market research institution IQVIA, Xeljanz enjoyed the sole lead old 14.7 billion won in sales in 2019. Its sales in 2020 were 16.2 billion won. Olumiant only sold 2.2 billion in 2019, but its sales rose greatly to 9 billion last year. In the first half of this year, Xeljanz (including the XR formulation) sold 7.8 billion, and Olumiant sold 5.6 billion, greatly narrowing the gap. Rinvoq, which started to record sales at the end of last year, sold 600 million won in the first half of this year. Its sales have been rising with the rapid reimbursement, however, the degree of growth is yet too small to catch up with Xeljanz nor Olumiant. However, Rinvoq suddenly increased its indications to 4 and change the future landscape. With the added indications, Rinvoq now owns the most amount of indications among JAK inhibitors. Pfizer plans to approach the atopic dermatitis market with a different JAK inhibitor other than Xeljanz. Unlike Xeljanz, which mainly inhibits JAK3, ‘Cibinqo (abrocitinib)’ mainly targets JAK1. Pfizer is known to have applied for Cibinqo’s approval and is being reviewed. However, the safety concern that remains in all JAK inhibitors is the issue. Based on the post-marketing safety study of Xeljanz, the US FDA concluded that it may increase the risk of severe heart disease such as heart attacks, etc. The FDA did not limit the boxed warning requirement to just Xeljanz, but expanded the alert to all JAK inhibitors and requested all three products to contain black box warnings. If this safety concern is not resolved, and the scope of treatment becomes restricted, this may affect and shrink the entire JAK inhibitor market.
- Policy
- Expanding the submission of opinions reflecting permission
- by Lee, Tak-Sun Oct 07, 2021 05:54am
- Opportunities for submitting opinions from industries will be expanded when reflecting permits based on the results of the reexamination. A pre-announcement procedure is added to the previous opinion inquiry. The MFDS announced that since the 27th of last month, the procedure for reflecting permits based on the results of the reexamination has been improved and applied. There was a 14-day period of submitting opinions through "Inquiry on Opinions on Permit Change" before reflecting the results of the retrial in the permission. An opportunity to submit opinions will be given one more time. An official from the MFDS said, "It is expected that opportunities for the industry to submit opinions will expand through a pre-announcement period." A total of 28 days of opinion submission period will be given. At the end of the pre-announcement period, a change order will be issued as before. After the change order, the changes in permission matters within three months must be reflected in the product insert. In this improvement plan, in order to distinguish between PMS survey results and general post-marketing adverse effect analysis evaluation, it will be divided into domestic post-marketing adverse effect analysis results and domestic post-marketing adverse effect analysis evaluation results. The results of the analysis and evaluation of the adverse effect after domestic marketing are the same as the existing re-examination method. An official from the MFDS explained, "We distinguish between the results of the adverse effect analysis collected in the post-market survey and the results of the adverse effect analysis reported after the market and reflect them in the permit, but we revised the phrase to clarify the analysis results." The improvement of the method of writing the improvement plan will be applied from the change of permission after the 27th of last month, and the pre-announcement period will be given from the items for re-examination received after the same day.
