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- 2026-04-07 13:28:21
- Policy
- NHIS completes pricing negotiations for Vemlidy, Brukinsa
- by Lee, Tak-Sun May 20, 2024 05:41am
- Negotiations between the National Health Insurance Service (NHIS) and pharmaceutical companies have been completed for 5 morning sickness drugs, hepatitis B drug Vemlidy Tab (tenofovir alafenamide hemifumarate), and Chinese company BeiGene Korea's new cancer drug Brukinsa Cap (zanubrutinib). The 5 morning sickness drugs underwent new drug pricing negotiations, Vemlidy underwent the price-volume agreement negotiations, and Brukinsa underwent a negotiation to expand its scope of use. According to the industry on the 17th, the NHIS recently updated its list of drugs completed negotiations and announced the completion of negotiations of the drugs listed above. The 5 morning sickness drugs that have completed negotiations are Hyundai Pharm’s ‘Diclectin Enteric Coated Tab,’ Boryung Biopharma's ‘Easy Morning Enteric Coated Tab,’ Dong Kook Pharmaceutical's ‘Mommyrectin Enteric Coated Tab,’ Shin Poong Pharm’s ‘Dinerzia Enteric Coated Tab,’ and Hanwha Pharma’s ‘Prelectin Enteric Coated Tab.’ These drugs are pyridoxine hydrochloride and doxylamine succinate combinations and are the only drugs indicated to treat nausea and vomiting during pregnancy in women who do not respond to conservative management in Korea. The government has been pushing for health insurance coverage of these items since last year as part of its policy to support pregnant women. The NHIS has been negotiating drug prices since mid-March and recently reached an agreement with the 5 pharmaceutical companies. Vemlidy has reportedly completed negotiations under ‘Type B’ of the Price-Volume Agreement system. The drug underwent the same type of negotiations last year, which resulted in a 4.7% reduction in its insurance cap price As the most-used drug in the hepatitis B treatment market, Vemlidy’s insurance claims continue to grow. Last year's prescription sales amounted to KRW 61.9 billion based on UBIST, up 26% YoY (from KRW 49.2 billion the previous year). PVA Type B is applied to drugs ▲whose insurance price had been adjusted under ‘Type A,’ or ▲that were listed for over 4 years without undergoing pricing adjustments under Type A and whose claims amount increased over 60% from the previous year; or ▲increased by 10% but the amount exceeds 5 billion. Vemlidy was found to have satisfied the conditions. Brukinsa was approved in May last year as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. In March, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recognized the adequacy of expanding reimbursement for Brukinsa as treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and has been in negotiations with the agency ever since. The items that successfully completed negotiations will the NHIS will reported to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare next week for reimbursement listing.
- Company
- Welireg can be prescribed in general hospitals in Korea
- by Eo, Yun-Ho May 20, 2024 05:41am
- Welireg, a rare anticancer drug for a small number of patients, can now be prescribed in general hospitals in Korea. According to industry sources on the 17th, MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan) passed the drug committees (DCs) of various medical centers in Korea including the National Cancer Center, Samsung Medical Center, and Asan Medical Center. Welireg was designated an orphan drug in Korea for the treatment of Von Hippel-Lindau disease in January last year, then formally approved in May of the same year. Specifically, the drug is indicated 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. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated in the open-label Study 004 trial, which investigated 61 patients with VHL-associated RCC who were diagnosed 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 study, 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 who 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%. Meanwhile, Welireg was additionally approved for a kidney cancer indication in the US. Its efficacy for the indication was confirmed in LITESPARK-005, a trial conducted on patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma (RCC) that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI. Results showed that Welireg improved progression-free survival (PFS) and reduced the risk of disease progression or death by 25% compared to everolimus in patients with advanced renal cell carcinoma who received a PD-1 or PD-L1 immune checkpoint inhibitor and a VEGF receptor-targeted therapy, either sequentially or in combination.
- Policy
- Erwinase price increases… Imfinzi renews RSA
- by Lee, Tak-Sun May 20, 2024 05:41am
- Immunotherapy drug for cancer, Imfinzi inj The price of Erwinase Inj (L-asparaginase), used to treat patients with acute lymphoblastic leukemia (ALL), is expected to increase. Additionally, Imfinzi, an immunotherapy drug for cancer, also succeeded in renegotiating risk-sharing agreements (RSA). Rhopressa, a treatment for open-angle glaucoma and intraocular pressure, has entered negotiations with the National Health Insurance Service (NHIS). According to industry sources on the 16th, the NHIS posted these negotiation results and schedules. Clinigen’s Erwinase inj was first listed in August 2019. The listing took 12 years and 5 months to be granted after the approval in South Korea. It can be covered by reimbursement when used in combination with other chemotherapy agents in patients with acute lymphoblastic leukemia (ALL) hypersensitive to Escherichia coli-derived asparaginase. At the time of reimbursement listing, the price of Erwinase was negotiated for KRW 520,000 per bottle, which was lower than the lowest price among A7 countries (KRW 702,564 (UK)). Erwinase Inj has been in negotiations with the NHIS regarding drug price increases through the adjustment application, and it recently met in agreement. The price increase has not been disclosed. In March, Erwinase Inj was granted for the changes of administration requirements from Grade 3 to Grade 2 from the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). AstraZeneca’s Imfinzi (Durvalumab) had an RSA agreement when it was reimbursement listed in April 2020. The contract ended in March. Despite of the contract ending, it continued negotiations with the NHIS and succeeded recently in negotiations. Imfinzi is covered by reimbursement for the treatment of patients with unresectable non-small cell lung cancer (NSCLC) who have not progressed after platinum-based concurrent chemoradiotherapy (CCRT). It is pursuing reimbursement expansion for bile duct cancer. The NHIS also disclosed pharmaceuticals under negotiations. As reported, Novartis' Ilaris injection (canakinumab) initiated negotiations in May. Ilaris passed the DREC review of the HIRA through real-world evidence (RWE) submission as a pharmacoeconomic evaluation exemption drug, following the principle of post-listing assessment. It is subject to a total cap on the type of reimbursement with RSA. Santen's glaucoma treatment, Rhopressa Ophthalmic Soln, has also entered negotiations. In April, it received conditional approval from DREC for reimbursement if priced below the evaluated amount. Subsequently, the pharmaceutical company has accepted the evaluated amount set by the DREC. Given that most pharmaceutical companies tend to take the pricing set during this period as the basis for price negotiation exemption, it is anticipated that negotiations with the HIRA will focus on expected reimbursement amounts.
- Company
- 'Imfinzi' shown to be effective for liver cancer
- by Son, Hyung-Min May 17, 2024 05:47am
- Hong Jae Chon, Professor of the Department of Hemato-Oncology at CHA Bundang Medical Center Imfinzi, an immunotherapy treatment for cancer, demonstrated effectiveness for liver cancer in addition to bile duct cancer. Consequently, it is expanding its uses in gastrointestinal cancer. AstraZeneca confirmed the effectiveness of Imfinzi in combination therapy with Imjudo, which targets CTL-A4, as a first-line treatment for liver cancer. The medical experts analyzed that this combination therapy has given hope for extended survival in patients with liver cancer. AstraZeneca hosted a press conference at Grand InterContinental Seoul Parnas on May 14th to commemorate the launch of a combination therapy, Imfinzi plus Imjudo. AstraZeneca’s Imfinzi is an immunotherapy for cancer that targets PD-1. It has been launched as a combination therapy with Imjudo, which targets CTL-A4, for the treatment of liver cancer. In June of last year, Imjudo was approved as a combination therapy with Imfinzi for the first-line treatment of liver cancer. Through this launch, Imfinzi has expanded its treatment area in gastrointestinal cancer, including bile duct cancer and liver cancer. Imfinzi was approved as a first-line treatment for bile duct cancer last month. The HIMALAYA Phase 3 trial demonstrated the effectiveness of Imfinzi plus Imjudo combination therapy. The trial compared the efficacy and the safety profile of Imfinzi plus Imjudo combination therapy to Bayer’s Nexavar, enrolling 1,171 patients with unresectable liver cancer who are 18 and over and have no prior treatment history. As part of the treatment regimen, Imfinzi plus Imjudo was administered on day 1 of week 1, followed by Imfinzi monotherapy only for the next 4 weeks. Nexabar was administered twice per day. Clinical results showed that Imfinzi plus Imjudo combination therapy reduced the risk of death by 22% compared to Nexabar monotherapy. Imfinzi plus Imjudo combination therapy’s overall survival (OS) was 16.4 months, whereas that of Nexabar monotherapy was 13.8 months. The difference in OS between Imfinzi plus Imjudo combination therapy and Nexabar monotherapy expanded over time. At week 18 of treatment, the OS of Imfinzi plus Imjudo was 48.7%, and that of Nexabar was 41.5%. The difference in OS was maintained up to 3 years of treatment. For the safety profile, the rate of Grade 3 or Grade 4 treatment-related adverse drug reactions in Imfinzi plus Imjudo combination therapy was 25.8%, and that of monotherapy was 36.9%. The Imfinzi plus Imjudo combination therapy is expected to compete with Roche’s combination therapy of Tecentriq, an immunotherapy for cancer, and Avastin, a targeted anticancer agent. Previously, Tecentriq and Avastin also proved to improve OS compared to Nexabar. Hong Jae Chon, Professor of the Department of Hemato-Oncology at CHA Bundang Medical Center, said, “In addition to Imfinzi, we now have more treatment options for liver cancer with the emergence of Tecentriq combination therapy. The advantage of Imfinzi plus Imjudo combination therapy is reduced risk of bleeding. The risk of bleeding in patients with liver cancer is high due to decreased liver function. Because Imfinzi combination therapy has reduced risk of bleeding, endoscopic surgery is possible right away.” “Patients with liver cancer who have accompanying liver function reduction have a high mortality rate. However, Imfinzi does not worsen the liver function. Based on my experience, treatment outcome is better than expected,” Chon added. “If combination therapy reimbursement is approved, its use will increase. Currently, it will be used without coverage for patients requiring the therapy.”
- Company
- Ferring Korea appoints Min-Jung Kim as new GM
- by Son, Hyung-Min May 17, 2024 05:47am
- Min Jung Kim, new General Manager of Ferring Pharmaceuticals Korea On May 16, Ferring Pharmaceuticals Korea announced that the company appointed Min-Jung Kim as its new general manager, effective as of May 1. The new GM joined the company in 2021 as Chief Financial Officer (CFO). Kim has over 20 years of experience in finance, business development, SCM, IT, and human resources at global pharmaceutical and medical device companies, including Novartis Korea and Pentax Medical Korea. In 2022, Kim served as the Chief Financial Officer for the Northern Asia region, where she improved Ferring's financial circumstances and drove business growth based on her financial expertise and strategic planning capabilities She also has verified her management capabilities in Korea, Hong Kong, and Taiwan, establishing various brand portfolio strategies and execution plans and collaborating with various stakeholders to derive results. Kim is also committed to building an innovative organizational culture and processes that can enhance employee engagement and professionalism to improve performance at Ferring Pharmaceuticals Korea. Based on her strong leadership, she has transformed Korea’s traditional hierarchical organizational culture into an open and communicative culture, while developing data-driven insights for efficient decision-making and a productive organization that fosters a productive work environment for its employees. "I am excited to be leading Ferring Pharmaceuticals Korea, which has always strived to provide innovative treatments to patients suffering from various diseases under the corporate philosophy, ‘People come first,'" said Kim. "Based on the experience and know-how I accumulated in the industry, I will make my best efforts to strengthen the company’s capabilities, while solidifying relationships with patients and stakeholders and contributing to the company's sustainable growth."
- Policy
- Daewoong develops 'Olumiant' generic…starts clinical trials
- by Lee, Hye-Kyung May 17, 2024 05:47am
- Daewoong Pharmaceutical develops a generic version of Lily Korea’s JAK inhibitor Daewoong Pharmaceutical has started developing product to compete against Lily Korea’s JAK inhibitor 'Olumiant (baricitinib).' Olumiant was approved by the Ministry of Food and Drug Safety (MFDS) in December 2017. It is used for treating adult patients with moderate-to-severe rheumatoid arthritis who do not respond well to disease-modifying antirheumatic drugs (DMARDs) and have no tolerability. The patents for Olumiant 2/4 mg is registered until July 2032. Therefore, pharmaceutical companies in South Korea can only launch their generics after avoiding patent infringement. On May 13, the MFDS approved clinical trials for Daewoong’s 'DWJ1607' and 'DWC202401' to conduct bioequivalence testing. DWJ1607 is targeting rheumatoid arthritis. The trial included 'baricitinib' as primary and secondary endpoints for evaluating the product’s efficacy. The trial is likely for the development of a generic version of Olumiant. Daewoong will conduct the DWJ1607 clinical trial, which will involve 44 adults aged 18 to 65 and 65 and over at H Plus Yangji Hospital. Olumiant, an oral medication taken once daily, improves convenience for patients who are averse to injections and those with rheumatoid arthritis who find it difficult to visit hospitals frequently. After being approved in 2017, Olumiant has been covered by health insurance as a secondary treatment equivalent to the bioequivalent agent since November 2018. In particular, at the time of approval, it only had indications for rheumatoid arthritis. In May 2021, it additionally secured efficacy and effectiveness for atopic dermatitis and in March of last year for severe alopecia areata in adults aged 18 and older. Before the Olumiant approval, there have been no other treatments with an indication for alopecia areata. Olumiant’s post-marketing survey (PMS) period has been adjusted to 6 years plus 35 months due to expansion in additional indication. As a result, PMS will end on November 10, 2026. Meanwhile, Pfizer’s 'Xeljanz (tofacitinib),' Lily’s 'Olumiant (baricitinib),' AbbVie’s 'Rinvoq (upadacitinib)' and Pfizer’s 'Cibinqo (abrocitinib)' are competing in the domestic market for JAK. According to a medical market research firm UBIST, last year’s outpatient prescription sales for JAK were KRW 13.7 billion for Olumiant, KRW 13.3 billion for Xeljanz, and KRW 12.4 billion for Rinvoq, with Olumiant having the highest sales.
- Company
- Repotrectinib receives orphan drug designation in Korea
- by Eo, Yun-Ho May 17, 2024 05:47am
- , The ROS1-targeted lung cancer drug repotrectinib received an orphan drug designation in Korea. The Ministry of Food and Drug Safety (MFDS) announced the designation in a recent announcement. Specifically, the indications repotrectinib received orphan drug designation for are as follows: ▲ treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. Repotrectinib was first approved by the US FDA in November last year as a treatment for NSCLC. It is available under the brand name Augtyro. The NTRK gene fusion solid tumor indication is under review after being granted a fast-track designation in February this year. The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial. Trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients. Progression-free survival (PFS) was nearly double that of previous targeted therapies. The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response). The median duration of response was 34.1 months. In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months. The trial also examined the drug’s effect in treating patients with resistance to existing targeted therapies. The 56 patients with resistance to existing therapies showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months. The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author. ROS1-positive NSCLC accounts for 2% of all lung cancers. The standard of care is to use targeted anti-cancer therapies that target the mutated gene, including ‘crizotinib’ and ‘entrectinib.’ Meanwhile, repotrectinib is gaining attention as a next-generation drug.
- Company
- Chinese Pharmas show presence at BIO Korea 2024
- by Moon, sung-ho May 16, 2024 05:48am
- Chinese pharmaceutical companies are starting to enter the domestic pharmaceutical and biotechnology market in earnest. This was the main observation made by the Korean industry at ‘BIO Korea 2024,’ cohosted by the Ministry of Health and Welfare and the Korea Health Industry Development Institute. The activities of major Chinese pharmaceutical and biotech companies at this year's BIO Korea attracted industry-wide attention. Among the companies, WuXi Biologics, a Chinese company that has grown into a global antibody contract development and manufacturing organization (CDMO), received the most attention. It set up a booth at the front of the venue and actively communicated with visitors and representatives from domestic pharmaceutical and biotech companies. With its CDMO competitors, LONZA and FUJIFILM Diosynth Biotechnology (hereinafter “Fujifilm”), also setting up booths at the event, it was evident that the competition among global CDMOs to expand their territories had begun in earnest. The companies seem to be working to expand their CDMO business through cooperation with domestic pharmaceutical and biotech companies. On the other hand, domestic companies competing in the CDMO market, such as Celltrion and Samsung Biologics, did not open their booths at the event. One Chinese company that stood out was Pharmaron Clinical, a CRO and CDMO company. Although the company’s size is not as large as other CDMOs like Wuxi, but the company actively engaged in talks to collaborate with domestic companies. A representative of a biotech company that participated in the event said, "Chinese companies most actively participated in this year’s BIO Korea event. They seem to be actively working to increase partnerships with domestic pharmaceutical and biotech companies to produce their treatments.” In addition, BeiGene, which has emerged as a strong player in the global anti-cancer drug market, also drew attention for its active cooperation activities at BIO Korea. Rather than setting up a booth, the company participated in the conference and held its own business briefing to strengthen partnerships with domestic Korean biotech companies. At the ‘Bio‧Pharmaceutical Global Open Innovation Cooperation and Activation Strategy’ session of the conference, BeiGene’s key executives in charge of BeiGene Asia introduced the company’s strengths and actively engaged in communication with domestic companies. During the session, BeiGene emphasized its financial resources and clinical strengths as a benefit. In fact, BeiGene’s self-developed anti-cancer drugs, such as Brukinsa (zanubrutinib), Tevimbra (tiselizumab), and Partruvix (pamiparib), are generating sales not only in China but also in the global market. The anticancer drug Brukinsa has been approved in more than 70 countries worldwide and is approved by the US FDA for five indications. In the first quarter of this year, BeiGene’s sales reached USD 752 million (KRW 1.0288 trillion), according to the company's latest financial result that it had released the previous day. Adam Roach, Vice President and Head of Asia Pacific at BeiGene, said, “Our biggest strength is that we don't need a separate CRO because we run our own clinical trials. Rather than using a CRO, we use our own internal clinical team that consists of over 3,000 people. We conduct more than 130 clinical trials in-house in about 48 locations." In the following lecture, Evan Goldberg, Vice President of Business Development at BeiGene, said, “Global big pharma companies used to be interested in only Japan in the Asia-Pacific region, but this is not the case anymore. Asia-Pacific countries, including Korea, have entered the global pharma and bio ecosystem, which is evidenced by the fact that Korean pharma and bio companies have been making frequent global technology transfers in recent years." Goldberg added, "BeiGene is currently working with global big pharma companies like Amgen, BMS, and Novartis, in addition to small and medium-sized biotechs. Some of these companies are seeking to enter the Asian market through the partnership, while Asian companies seek partnerships with the dream of going global." The domestic pharma and biotech companies that participated in BIO Korea have also noted the growth of Chinese companies and agreed on the need to revisit the companies’ treatments. An official from a pharmaceutical and biotech consulting firm who requested anonymity, said, "BeiGene’s clinical strength is definitely attracting attention in the global market. In the past, it only had a large number of trial enrollees in China, but the company is now actively conducting clinical trials in the global market. Considering the recent clinical trials it has been announcing, it’s time for the company to reestablish its position not just in Asia but also in the global market.
- Company
- Xcopri’s cumulative revenue surpasses KRW 1 trillion
- by Chon, Seung-Hyun May 16, 2024 05:48am
- Xcopri, SK Biopharmaceutical's new epilepsy drug, is continuing to show strong growth in the US market. Since its launch, sales have continued to rise every quarter, with cumulative sales exceeding KRW 600 billion. When including the revenue it had collected by licensing-out Xcopri’s technology, the company has secured more than KRW 1 trillion with Xcopri alone. According to SK Biopharmaceuticals on Thursday, Xcopri recorded KRW 90.9 billion in US sales in Q1 this year. This is a 68.6% rise from the KRW 53.9 billion it had posted in Q1 last year and is the largest amount earned since the drug entered the US market. This is also a 17.0% increase in a single quarter, from the KRW 77.7 billion in Q4 last year. Quarterly U.S. sales of Xcopri (Unit: KRW 100 million, Source: SK Biopharmaceuticals) Xcopri, which contains ‘cenobamate,’ is a new drug for epilepsy that SK Biopharmaceuticals. SK Biopharmaceuticals had independently performed the whole course of Xcopri’s development and commercialization from early development to US Food and Drug Administration (FDA) approval. It is prescribed for the treatment of partial-onset (focal) seizures in adult patients. Its mechanism of action relieves seizure symptoms by simultaneously regulating two targets related to excitatory and inhibitory signaling, which are causes of epilepsy. The company received approval for its cenobamate under the brand name ‘Xcopri’ in November 2019, and has been selling the drug through SK Life Science since May 2020. SK Life Science has about 150 medical representatives. Epilepsy is a condition that is treated by a small number of focus specialists in the United States. Due to the small number of target physicians, the company was able to sell the drug directly in the U.S. with such a small sales force. SK Life Science’s marketing center, which consists of sales and marketing personnel, has experts with more than 20 years of experience in successfully launching and selling epilepsy treatments and major central nervous system drugs at Johnson & Johnson, UCB, and other leading companies in the U.S. CNS market. Since its U.S. launch, Xcopri has been setting new sales records every quarter. It generated its first revenue of KRW 2.1 billion in Q2 2020 and surpassed KRW 10 billion in Q1 2020. Its sales surpassed KRW 50 billion in revenue in Q1 last year and have reached nearly KRW 100 billion in quarterly revenue this year. Xcopri’s cumulative revenue in the US totaled KRW 621.7 billion. Since 2019, Xcopri has earned more than KRW 400 billion in technology fees. In February 2019, SK Biopharmaceuticals signed a licensing-out agreement with Switzerland's Arvelle Therapeutics to transfer technology on cenobamate for up to $530 million. At the time, SK Biopharmaceutical received an upfront payment of $100 million with no obligation of return. In October 2020, the company entered into an exclusive licensing agreement with Ono Pharmaceutical for Ono to develop and commercialize Xcopri in Japan. Under the agreement, SK Biopharmaceutical received an upfront payment of ¥5 billion with no obligation of return. In November 2021, SK Biopharmaceuticals licensed out 6 new central nervous system (CNS) drugs including cenobamate to the Chinese company, Ignis Therapeutics. Under the deal, SK Biopharmaceutical received an upfront payment of $20 million. Through the technology export, SK Biopharmaceutical also acquired 150 million shares of Ignis (share amounts to 44.9% including common stock). In December 2021, SK Biopharmaceutical signed a license deal with Endo Group for the commercialization of its epilepsy drug cenobamate across Canada. Under the deal, SK Biopharmaceutical received an upfront payment of CAD 20 million. Paladin Labs Inc, a Canada-based operating subsidiary of Endo, will be responsible for all commercial activities related to cenobamate in the region, including its release. Endo is a global healthcare company headquartered in Ireland. In July last year, SK Biopharmaceuticals signed a licensing out deal with the Brazilian pharmaceutical company Eurofarma Laboratorios SA for cenobamate. Under the agreement, SK Biopharmaceuticals will receive an upfront payment of USD 15 million and up to USD 47 million in milestone payments. Under the licensing out agreement, Eurofarma will be selling cenobamate in 17 Latin American countries including Brazil and Mexico In addition to upfront payments, the company has also received milestone payments upon cenobamate’s approval abroad. SK Biopharmaceuticals received USD 123.22 million from its European partner Angelini Pharma as milestone payments in 2022. Angelini Pharma (formerly Arvelle Therapeutics UK) has paid additional milestone payments after receiving marketing authorization for Xcopri from the European Commission in March 2021. SK Biopharmaceuticals’ cash inflow from upfront payments and further milestones from the technology transfer of cenobamate is USD 301.22 million and ¥5 billion. The company has secured about KRW 450 billion through upfront and milestone payments through technology transfer agreements with cenobamate. Combined with US sales, the single product had brought in over KRW 1 trillion. Xcopri’s sales growth has also improved SK Biopharmaceuticals’ performance. In Q1 this year, SK Biopharmaceuticals posted an operating profit of 10.3 billion won, a YoY turnaround and its sales rose 87.5% YoY to KRW 114 billion. An official from SK Biopharmaceuticals said, "This is the first time since its establishment that SK Biopharmaceuticals has achieved a surplus for 2 consecutive quarters, and it is significant that the profitability in Q1 was achieved entirely due to the growth of cenobamate’s sales in the US.”
- Opinion
- [Reporter’s View] Drug Review Coordination Council
- by Kim, Jin-Gu May 16, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) has launched the Drug Approval and Review Coordination Council. The council will directly receive coordination requests from complainants when matters for supplemental measures arise during the drug approval and review process. With the Director-General of the Drug Safety Division heading the council, director-level officers at MFDS and 4-5 external experts will be coordinating the issues at hand. In other words, the council will coordinate issues that the MFDS has requested supplementation for under the leadership of the Director-General of the Drug Safety Division. Although it is a 1-year pilot program, the pharmaceutical industry has high expectations. This is because a significant portion of the pharmaceutical industry's complaints related to approval and review arose during the process of handling the supplementary measures. There always has been a discrepancy between the data requested by the MFDS and the data submitted by the pharmaceutical companies, and the process of closing the gap has always been fraught with complaints. The pharmaceutical industry was constantly thirsty for communication in this area. As the MFDS voluntarily offered to meet this need in this situation, the pharmaceutical industry welcomed the decision with open arms. In particular, the industry expressed expectations over the fact that the coordination process will be handled by the Director-General of the Drug Safety Division. The industry’s hope is that the complaints, which had become an ongoing hassle between working-level staff members of the MFDS and companies, will be adjusted more flexibly from a larger direction. However, no system, no matter how good, can satisfy 100% of the complainants who have expressed concerns over MFDS’s plan. The biggest concern is that the approval and review period could increase. With so many complaints focused on the processing of supplemental measures, the fear is that handling a large number of coordination complaints with limited manpower will create a kind of bottleneck phenomenon, increasing the time required for approval and review. As if acknowledging these concerns, the MFDS announced that it will exclude complaints for which there are clear regulations or have already gone through Central Pharmaceutical Affairs Council review. Furthermore, the MFDS is also planning to limit the number of coordination applications to '1 case per product by company'. Some in the industry are disappointed with this decision regarding the restriction. There were also concerns about equity. As the criteria for determining the coordination subjects is not clearly laid out, there is a possibility that complaints may arise on how the MFDs are only responding to the needs of certain pharmaceutical companies. The MFDS’s decision to open up a communication channel that the pharmaceutical industry has long awaited for is great news. Some industry insiders have complimented that the “MFDS has changed for the better.” However, this is the crucial moment. In order for the acclaimed MFDS’s plan to avoid becoming a ‘nothingburger,’ the authorities now need to prepare substantive sub-regulations, such as criteria for selecting coordination subjects, coordination procedures, and on how to apply the coordinated results.
