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- 2026-04-12 01:36:37
- Company
- 3rd PD-1i Jemperli to soon receive approval in Korea
- by Eo, Yun-Ho Aug 05, 2022 06:06am
- A third PD-1 inhibitor is knocking to enter the Korean market. According to industry sources, GSK Korea’s PD-1 inhibitor cancer immunotherapy ‘Jemperli (dostarlimab),’ which the company applied for approval earlier this year, may be approved within the year. If approved, Jemperli will become the third PD-1 inhibitor introduced to the Korean market following Ono·BMS’s ‘Opdivo (nivolumab),’ and MSD’s ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that were first indicated as melanoma treatments, Jemperli was first approved in the US in April last year as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.’ In August of the same year, Jemperli was additionally approved for the treatment of adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options. GSK plans to add other indications to endometrial cancer in Korea as well. The efficacy of Jemperli was confirmed through the multicohort GARNET trial that included a cohort of patients with dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. Trial results showed an objective response rate (ORR) of 43.5% and the disease control rate of 55.6% in the Jemperli-treated group. The median duration of response was not reached yet, and the rate of patients whose duration lasted 6 months and 12 months were 97.9% and 90.9%, respectively. Meanwhile, the other companies are also actively working to expand their indication and reimbursement for Keytruda and Opdivo in Korea as well. MSD succeeded in expanding the reimbursement standards for Keytruda to first-line NSCLC in 1H this year, and Opdivo's indication as a first-line treatment in gastric cancer has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.
- Policy
- Security elaboration/ ultra-high-priced new drug coverage
- by Kim, Jung-Ju Aug 05, 2022 06:04am
- In order to strengthen accessibility to new drug patients, the government has steadily increased coverage by opening a benefit gateway. However, due to the development of innovative new drugs, limited funding of health insurance is a problem to catch up with the ultra-high price trend of anticancer drugs and rare disease treatments. The challenge of overcoming the sustainability issue remains a challenge. As Zolgensma, a treatment for Spinal Muscle Atrophy (SMA), called "ultra-high-priced one-shot treatment," was listed on the benefit starting this month, the government considered ways to improve accessibility from the basic definition of expensive new drugs. The procedure for registering new drug benefits in Korea is carried out sequentially by applying for benefits from pharmaceutical companies, deliberating and evaluating the HIRA, negotiating drug prices between the NHIS and companies, and deliberating and voting by the Health Insurance Policy Review Committee. However, it has been pointed out that the accessibility of drugs requiring urgent benefits is disrupted as HIRA deliberation and evaluation usually takes 120 days, 150 days for RSA targets, 60 days for drug price negotiations, and 30 days for review by the Health Insurance Policy Review Committee. The biggest problem is by far the price. The problem of price has been a constant obstacle even in the 2010s, when social needs were not heavily reflected. Since the government and the insurance authorities judged whether or not the salary was paid and the price was the top priority, there were many problems with the appearance of high-priced new drugs. Starting with the introduction of RSA in 2014, the government introduced a permit-evaluation linkage system in the same year and introduced a new economic evaluation data submission system and a drug price negotiation system in 2015 to improve accessibility to high-priced new drugs. With the listing of Zolgensma, the government announced plans to create a definition of expensive drugs that it has been preparing and expand the mechanism for shortening negotiations, while strengthening follow-up management and monitoring. The government will actively adopt a patient-level performance-based model by improving RSA, which used to be a financial base, but strengthen follow-up monitoring to utilize a payment method suitable for treatment effects and improve PVA in operation. In addition, it was decided to prepare a pre-approved standard operating procedure (SOP) before taking ultra-high-priced drugs. In addition, the National Assembly's legislative investigation office says it is desirable to discuss the introduction of a "pre-entry and post-evaluation" method as a new benefit pharmaceutical companies by paying the cost or evaluating the effectiveness of treatment after administration when claiming treatment expenses exceeding the set total benefit. This is the way that related academia and patient organizations have suggested so far, and it can be said that it belongs to the same context in the large framework as RSA's performance-based model. In order to make it common, the authorities and insurers should consider weakening the insurer's bargaining power and devices for effective operation in the process of negotiating drug prices. In addition, the National Assembly also suggested the need to set up a separate fund to solve financial problems that will be affected by strengthening the guarantee of expensive new drugs. This can be referenced in that advanced insurance countries such as the United Kingdom operate various types of drug funding systems as a mechanism for salary exceptions in consideration of uncertainties that arise when there is not enough data to evaluate the value of drugs. The government plans to subdivide the management method and registration process by lowering the speed and evaluation barrier of the benefit entry stage, increasing follow-up monitoring and evaluation, and improving the reference criteria for foreign drug price adjustment in the future. It is important to pay attention to how much more sophisticated the new drug guarantee policy will become in the future, so it is also important to pay attention to the parliamentary audit in the second half.
- Policy
- MOHW reluctant to CVS's request to expand SRADs
- by kang, hae-kyung Aug 05, 2022 06:04am
- The Ministry of Health and Welfare expressed disapproval over the convenience store industry's request that the scope of Safe and Readily Available Drugs (SRADs) should be expanded to antacids and burn ointments for sale at convenience stores. The MOHW explained that the SRAD system is a unique exception made from the healthcare system’s perspective, and that the policy environment is now changing so that drugs may be purchased from pharmacists at public late-night pharmacies or pharmacy vending machines. At the 'Policy Improvement Seminar for the Sustainable Development of Close-to-Life Retail Industry' that was organized by the Korea Franchisee Union and hosted by Seung-Jae Choi's Office of the People Power Party, Tae-Gil Ha, Director of Pharmaceutical Policy at MOHW, reiterated that the SRAD system is a special exception made from the perspective of Korea’s healthcare system. Director Ha said, “Pharmaceuticals are biologically active, and contrary to the claim that ‘no side effects have been reported from the use of SRADs sold at convenience stores, around 200-400 adverse events are being reported annually through the Ministry of Food and Drug Safety and Korea Institute of Drug Safety & Risk Management. Although in principle, pharmacists need to dispense pharmaceuticals, the SRAD system was allowed as an exception for the convenience of the patients for their use at times that pharmacists cannot cover. We are not aware how much SRADs' sales contribute to sales at convenience stores, but we have to put consumer convenience and health first." Director Ha added, “Although there is a claim that the operation of late-night pharmacies is poor, policy changes such as the expansion of public late-night pharmacies and pharmacy vending machines are currently being made. Still, there is much conflict over SRADs in reaching a social consensus.” In other words, in addition to the occupational conflicts that arise among pharmacists, experts have concluded that it is difficult to designate antacid and antidiarrheal drugs as SRADs. Director Ha also noted that contrary to the claims of the convenience store industry, problems such as rule violations on the sellers’ part are also being raised. He said, "Some media outlets have covered how seller compliance violations are made in almost 85% of the cases, and that there is demand for legislation to strengthen seller education and reinforce enforcement of regulations. The lack of a systemic system for dispensing SRADs at convenience stores also acts as a burden.” When a policy signal is issued, pharmacists’ associations deliver the news to local pharmacist societies, but no clear systematic delivery route for such news exists for SRADs in convenience stores. Director Ha said, “Patient convenience is of course most important, but please do understand that national statistics on such a demand are not clear and we have to prioritize patient convenience while ensuring the safety of the healthcare system."
- Company
- Celltrion, applies for Phase III U.S. Targeting
- by Lee, Seok-Jun Aug 05, 2022 03:32am
- A clinical trial will be conducted so that Celltrion can alternatively prescribe CT-P17 (Yuflyma), an autoimmune disease treatment developed by itself, with the original Humira. Celltrion announced on the 1st that it recently submitted a global phase 3 to the FDA to secure interchangeability between CT-P17 and Humira. If it is designated as an interchangeable biosimilar, it can be prescribed by replacing the original at a pharmacy without intervention by a doctor. Phase 3 is conducted in 366 patients with plaque psoriasis. Pharmacokinetics, efficacy, and safety will be compared and verified between the group that took multiple intersections between Yuflyma and Humira and the group that administered Humira. Yuflyma is the world's first high-concentration Humira biosimilar that obtained permission from the European Medicines Agency (EMA). It was developed as a formulation that halves drug administration compared to low concentrations and removes citrate, which can cause pain. It started selling in major European countries, and the U.S. has completed a patent agreement with U.S. developer Abbvie so that it can start selling on July 1st next year, and expects FDA approval by the end of this year. Celltrion plans to secure Humira's interchangeable biosimilar status in the U.S. through interchangeable clinical trials with the advantages of Yuflyma's high-concentration formulation. Humira's global sales last year were about $20.69 billion and $17.33 billion in the United States.
- Company
- Oncaspar changed supplier
- by Eo, Yun-Ho Aug 05, 2022 03:28am
- Oncaspar, a combination treatment for acute lymphocytic leukemia (ALL), which has been supplied by developer Servier, is forming a stable prescription maintenance environment. According to related industries, it passed the Drug Committee (DC) of the Big 5 general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Since May, the supplier has been changed at the rare drug center, but the prescription code has been quickly secured. Oncaspar obtained permission for import items from the MFDS in February last year as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL). This drug maximizes the drug circulation half-life through pegylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-asparaginase, which was previously administered once every other day. Considering the high incidence of Acute Lymphoblastic Leukemia, in particular in pediatric patients, improved use to allow administration every 14 days is expected to reduce injection burden, physical pain, and hypersensitivity to injection treatments in pediatric patients and patient caregivers suffering from frequent anti-cancer injections. In addition, it is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. First approved in 1994 as a secondary treatment for Acute Lymphoblastic Leukemia in the United States and Germany, Oncaspar was recognized as a primary treatment for all Acute Lymphoblastic Leukemia in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in children and adults with acute lymphocytic leukemia aged 18. Oncaspar is currently a treatment for Acute Lymphoblastic Leukemia, which is primarily recommended in major international guidelines and treatment protocols such as NCCN, ESMO, and Children's Oncology Group (COG), and is used in 62 countries.
- Company
- Samjin, will develop new drugs with AI company in Canada
- by Lee, Seok-Jun Aug 05, 2022 03:28am
- Samjin Pharmaceutical announced on the 2nd that it has signed a joint research contract for AI new drug development with Cyclica, a Canadian artificial intelligence new drug development platform company. Through the agreement, Samjin Pharmaceutical will propose to Cyclica multiple drug targets currently under review. Cyclica is going to secure candidate materials that are highly likely to be developed by applying AI-based new drug candidate material discovery platform (Ligand DesignTM) technology. Lee Soo-min, head of the Samjin Pharmaceutical Research Center, said, "Joint research using AI technology with Cyclica will significantly reduce the time and cost required to develop new drugs. We will cooperate with leading domestic and foreign research institutes and companies to efficiently discover and develop innovative new drugs through open innovation strategies." Cyclica was selected as one of the world's 13 healthcare AI startups by CB Insights, a technology market research institute in 2020. It is conducting joint research with many domestic and foreign companies including global Big Pharma such as Merck KGaA and AstraZeneca.
- Policy
- Biogen’s Alzheimer’s disease TX entry unclear in Korea
- by Lee, Hye-Kyung Aug 04, 2022 06:05am
- Introduction of the world’s first Alzheimer’s disease treatment, ‘Aduhelm (aducanumab),’ has virtually become unclear in Korea. The results of the Central Pharmaceutical Affairs Council meeting that was held on July 12th that was recently disclosed by the Ministry of Food and Drug Safety showed that the expert advisory board concluded that the application data filed for an Alzheimer’s disease treatment "was not sufficient to be accepted as a confirmatory clinical trial." Although the deliberated product's name and ingredient were not disclosed in the minutes of the meeting, one committee member mentioned, “Since the FDA approval, the US news had covered how the ‘Biogen's statisticians used magic' to become up with much analysis favorable to Biogen, which it had submitted for accelerated approval.” From the comment, it can be inferred that the item that was deliberated was Aduhelm, for which Biogen submitted an application for approval in July last year. Aduhelm received conditional approval from the U.S. FDA in June last year with a post-approval trial required to verify that the drug provides the expected clinical benefit. The conditional approval made in the US was in itself not easy. In November 2020, the company was unable to satisfy the primary endpoints in the EMERGE and ENGAGE trials, due to which the FDA advisory committee had decided to recommend non-approval due to insufficient evidence proving its effectiveness. However, Biogen further analyzed its clinical data and received conditional approval from the FDA based on efficacy validated in the high-dose group. The clinical trial results that Biogen submitted for marketing authorization in Korea were data that did not satisfy the primary and secondary efficacy endpoints. One committee member said, “It is not reasonable to discuss approval when the data submitted did not achieve the primary efficacy endpoint. The members of the FDA advisory committee opposed to the approval, but clinicians’ position was that the drug should be approved as there is no other treatment available and the biomarkers showed an effect. Many of the advisory board members resigned, opposing the approval.” Another member said, “It is understandable that such discussions arise because there are currently no treatments available in the field of dementia treatment, but from a statistical point of view, there is no controversy that the data submitted was from a failed clinical trial. We will not be accepting additional analysis results on the submitted data after declaring the data non-acceptable.” Most of the members agreed that the clinical data alone cannot be accepted as confirmatory clinical results, and the committee chair also said, “The biomarker part will be discussed afterward. The conclusion that was made this time is that the Phase III clinical trial results cannot be accepted as a confirmatory trial.” Meanwhile, iBiogen’s CEO Michel Vounatsos had resigned at Biogen’s 2022 Q1 earnings release in May, taking responsibility for Aduhelm's poor performance, upon which Biogen announced that it would substantially eliminate its commercial infrastructure for Aduhelm.
- Company
- Chinese partner terminates agreement with Medytox
- by Nho, Byung Chul Aug 04, 2022 06:04am
- Medytox is having difficulty making entry into the Chinese market. At a presentation on ‘Follow-up regarding Bloomage·Medytox joint venture Medybloom's progress' that was held on the 1st, Bloomage Biotechnology announced that “the company will discontinue the partnership with Medytox and seek opportunities with other botulinum toxin companies." As one of the largest hyaluronic acid production and marketing enterprises in the world, Bloomage Biotechnology is known for its professional sales power in China's cosmetic surgery market. With the termination of the partnership, Medytox will now have to seek new venues for entry into the Chinese market without achieving much during the 5 years after establishing the joint venture, MedyBloom China, with Bloomage Biotechnology in 2017. Medytox applied for the approval for its botox product Meditoxin (Neuronox) to the National Medical Products Administration in China in February 2018, but the agenda is pending for over 4 years. Moreover, the global pharmaceutical company Allergan (currently Abbvie) returned the rights of Medytox’s liquid botulinum toxin candidate (MT-10109L) to Medytox in September last year. This return of rights, which occurred 8 years after the company licensed out the development and global sales rights of its liquid botulinum toxin candidate to Allergan in September 2013, was expected to have caused considerable aftermaths for the company. With the termination of the agreement, Medytox will not be able to receive the remaining milestone payments ($262 million/ ₩342.5 billion) from Allergan. Allergan had planned to sell the liquid botulinum toxin in the global market excluding Korea and Japan after undergoing clinical trials and approval processes, but this is also now unclear. With Medytox facing difficulties in 2 of the 3 largest global botulinum toxin markets - the US and China - other competitors are accelerating their market defense and penetration strategies for their botox products. Hugel’s Letybo continues to rank first in the Korean market and is solidifying its position as the market leader with the recent marketing authorization and launch of its botulinum toxin in China. Daewoong’s Nabota has also been increasing its global market sales and shares upon receiving marketing authorization and release in the US. Also, Nabota is coordinating the timing for its entry into the European market, and is on the verge of achieving a grand slam of being approved in all three global major markets as it has completed Phase III clinical trials and is about to receive marketing authorization in China. Meanwhile, Medytox had relayed to the press that “We received a letter from Bloomage regarding the contract termination, but nothing has been finalized. We will be reviewing measures from various angles to come up with the optimal plan for entering the Chinese botulinum toxin market.”
- Company
- MSD Korea to introduce cancer drug Welireg to Korea
- by Eo, Yun-Ho Aug 03, 2022 06:00am
- MSD is expected to introduce another oncology pipeline to Korea. According to industry sources, MSD Korea has submitted an application for the approval of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan),’ to the Ministry of Food and Drug Safety. The drug had been designated as an orphan drug in January for the treatment of Von Hippel-Lindau disease. The indication the company applied in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. After being first approved in the US in August, Welireg was also approved in the U.K. and Canada. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. Welireg’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 VHL-associated RCC patients diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the trial, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
- Company
- Competitivity of K-Pharma-Bio manufacturing facilities rises
- by Lee, Seok-Jun Aug 03, 2022 06:00am
- The competitiveness of K-Pharma/Biomanufacturing facilities are rising. With more and more companies passing inspections by the US FDA (Food and Drug Administration), the institution considered to have the highest standards, the companies that have passed inspections plan to advance into the global market in earnest. Recieves first cGMP certification in Asia for its oligonucleotide manufacturing plant ST Pharm recently became the first in Asia to receive the US FDA’s Good Manufacturing Practice (cGMP) certification for its oligonucleotide plant. The company received an inspection classification of NAI (No Action Indicated) from FDA’s PAI (pre-approval inspection) of its oligonucleotide factory in Banwol Campus, demonstrating the R&D capability of its facility. With the approval, the company’s oligonucleotide orders are expected to increase. Although ST Pharm had only been exporting drug substances for oligonucleotide treatment used in clinical trials to the US market, the recent FDA cGMP approval will now enable the company to make large-scale exports for commercial use. An ST Pharm official said, “We have 4 more FDA PAIs planned by the first half of next year. This means that FDA approvals of new drugs that ST Pharm supplies drug substances for is imminent. The FDA cGMP approval the company received this time is expected to positively impact the future on-site inspections in plan.” Registered as the first anticancer drug API manufacturing facility in Korea Inist ST’s Osong plant has also recently been registered as a cGMP anticancer drug API manufacturing facility by the FDA. With the registration, the Osong plant became the first cGMP-certified anticancer API manufacturing facility registered as a highly active noncytotoxic anticancer API specialized manufacturing facility A company official said, “With the news spreading, we are receiving a series of love calls from existing and new customers that aim to advance into the US and other advanced pharmaceutical markets. The FDA certification has reaffirmed our global-level API manufacturing facility and quality control capabilities.” By passing FDA inspections, the pre-investment that had been made by Inist ST is also gaining momentum. In October last year, the company started the construction of a 40 billion won 'Global API synthesis cGMP plant' on the site of the Osong plant site to expand its CMO business. The facility is expected to be completed in October. Succeeds in manufacturing COVID-19 mRNA drug substance in addition to finished product Samsung Biologics succeeded in trial manufacture of the mRNA drug substance. With the company's success in establishing the mRNA drug substance facility following the successful CMO of Moderna’s finished mRNA product in the 2nd half of last year, the company has now established a one-stop end-to-end mRNA production system. The company signed aCMO partnership with the US company GreenLight Biosciences for the drug substance of GreenLight’s COVID-19 vaccine candidate at the end of last year. For 7 months since then, the company completed technology transfer, scale-up and established its RNA drug substance manufacturing facility in May this year. Samsung Biologics recently succeeded in the first trial manufacture and has finished preparations for the large-scale commercial manufacturing of the mRNA vaccine drug substance. Trial production is a process verification stage that is carried out before full-scale commercial production. The success of the pilot manufacturing is considered as having full capacity at the cGMP level. The second trial production is expected to take place within this month. A market official said, “An increasing number of pharmaceutical and biopharmaceutical companies have passed FDA’s inspections with their differentiated manufacturing facilities. Such facility R&D is now treated as competitive as the company's material R&D.”
