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- 2026-05-04 00:25:53
- 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.
- Company
- "Camzyos, reimbursement would benefit gov and patients"
- by Eo, Yun-Ho May 16, 2024 05:48am
- Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital The reason for delayed drug development in a particular disease typically falls into one of two. It’s either low awareness of the disease or challenges to drug development. Despite falling into these two categories, 'Camzyos (mavacamten)' was developed. It is a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a rare heart disease characterized by thickened heart muscles that cause narrowing or obstruction of the left ventricular outflow tract (LVOT). Not only does it cause abnormality in heart structure, but it decreases heart function. The symptoms include shortness of breath, chest pain, dizziness, and fainting. It is a fatal disease that could cause cardiovascular complications and sudden cardiac death. Furthermore, there has been a lack of disease-modifying treatment besides short-term management of symptoms. Thus, the development of Camzyos, which works by significantly reducing cardiac myosin actin cross-bridge formation, was exciting news to doctors. However, the concern is whether it could be covered by insurance reimbursement. Although Camzyos was approved in South Korea in May of last year, it has not yet been covered by reimbursement. BMS is pursuing an application for the drug’s listing and is awaiting the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). Daily Pharm interviewed Hyung-Kwan Kim, Professor of the Department of Internal Medicine at Seoul National University Hospital, about Camzyos’ value and the necessity of reimbursement. -HCM diagnosis has increased following the expansion of reimbursement criteria for cardiac ultrasonography. Has the diagnosis rate increased in the real-world? What is the patient size of HCM in Korea? We don’t have accurate data for Korea yet, but the National Health Insurance Service (NHIS) data shows that the number of patients who are diagnosed with HCM has increased since 2010. Between 2010 and 2016, the number of HCM patients doubled. The increase in diagnosis rate may have been due to the routine health examination in Korea: cardiac ultrasonography can be added to the examination option. This supports the trend since the number of diagnoses has increased, particularly among patients over 50. -It seems that there is a low level of awareness among medical personnel regarding oHCM. In fact, due to the lack of effective treatments for HCM, awareness of the condition has been low, and research has not been very active. Even if someone showed signs of suspected HCM or received a diagnosis, the lack of available therapies meant that coordinated care across tertiary healthcare facilities was almost non-existent. Patients were typically advised to manage their symptoms and avoid strenuous exercise, as no competitive treatment options were available. -The development of Camzyos must be particularly meaningful. Previously, beta-blockers and calcium channel blockers were commonly used to treat oHCM. However, these medications do not target the pathophysiological mechanisms of oHCM, leading to limited effectiveness, and many patients do not experience significant improvement. Disopyramide was previously used but is no longer recommended due to its side effects. Furthermore, since it is not prescribed in South Korea, there are few options for treating oHCM. Medical professionals couldn't help but have high expectations when Camzyos became available. Initially skeptical, I found the clinical data remarkably convincing regarding effectiveness. Even data from patients treated with Camzyos abroad showed significant changes in cardiac ultrasonography findings. Among the seven patients under my care who received Camzyos, almost all showed improvement to the extent that it could be 100%, with effects evident within a month. -The clinical results of Camzyos demonstrated improved exercise capacity in oHCM patients. How significant is this result? Exercise capacity can be categorized into objective measures that can be quantitatively assessed and subjective measures that patients evaluate based on their experience. In clinical studies, Camzyos significantly improved both of these indicators. The subjective indicators of patients currently undergoing Camzyos treatment have also improved across the board. NYHA classification has improved by at least one level, with some cases improving from grade 3 to grade 1. In addition to exercise capacity, cardiac function can be evaluated by checking NT-proBNP levels through blood tests. Among the patients under care, those with elevated NT-proBNP levels at the start of Camgios treatment all experienced decreased NT-proBNP levels. Some patients saw remarkable effects, with NT-proBNP levels dropping from 2,000 to 3,000, within the normal range after just one month of Camzyos treatment. -Last year, the European Society of Cardiology (ESC) updated its guidelines for the management of cardiomyopathy for the first time in about 9 years since 2014, adding recommendations for the treatment of Camzyos. What do you think about this? It's promising. I had hoped it would be recommended as a first-line treatment, but ESC seemed to take a conservative approach. Considering the nature of ESC guidelines, where first-line recommendations are not often made right away, there is ample possibility for Camzyos to be recommended as a first-line therapy in the future. -It sounds like Camzyos could possibly be a first-line treatment. Yes. Considering the pathophysiological mechanism of oHCM, I believe it is important for Camzyos to become the first-line treatment option in the long term. This way, we can reduce the unnecessary time and medical expenses of patients who use ineffective medication for 2-3 months. -The concern is that Camzyos is still a non-reimbursed drug. There must be disappointments in the real-world. oHCM is associated with a higher risk of stroke because atrial fibrillation and aneurysms of the left ventricle are not uncommon even in younger age groups. In the case of a oHCM patient in his late 40s, who had no symptoms at all, an aneurysm was found in a screening test conducted every 2-3 years. Currently, in Korea, NOACs (new oral anticoagulants) cannot be used to prevent stroke with aneurysms alone, and warfarin must be used, which requires continuous monitoring when administering warfarin, which is very difficult. So, I explained to the patient that I thought oHCM caused the aneurysm and suggested surgery or treatment with Camzyos. In the end, the patient opted for Camzyos treatment, and within one month, what appeared to be a pericardial aneurysm improved, and the condition of the heart that had been obstructed improved. If he hadn't been treated for Camzyos, his aneurysm would have become stuck, increasing his risk of stroke, and he would have been forced to stay in the hospital and suffer from shortness of breath while being treated with ineffective medications. If Camzyos is covered by reimbursement, patients with similar difficulties will be able to receive many benefits and help. However, it seems that there are many difficulties in discussing reimbursement adequacy with previous treatment options as a comparison. In the real-world practice of medicine, many patients are unable to take their medications due to high non-reimbursement costs and are just waiting for reimbursement. -Camzyos is awaiting the DREC review. As mentioned before, medical personnel voice that there are no comparable treatments to Camzyos. What should government consider when determining the reimbursement? From a short-sighted point of view, reimbursement listing of a drug may seem like a disadvantage in health insurance finances, but if we expand our view on a macro level, we can see that this is not the case. If left untreated, patients with oHCM are at increased risk of developing heart failure, which inevitably increases the direct and indirect health care costs. In addition, an aneurysm increases the risk of stroke, which adds the cost of hospitalization to the cost of stroke medication. These costs can be considered in the long run as more patients are treated with Camzyos before complications occur. If their condition improves, the additional costs associated with emergency room admissions and treatment for other complications can be reduced. Ultimately, patients, doctors, and health authorities can benefit from each other.
- Policy
- Multiple sclerosis drug Ocrevusis approved in Korea
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced on the 13th that it has approved Roche Korea’s orphan drug Ocrevus (ocrelizumab) for multiple sclerosis (MS) in Korea. Multiple sclerosis is a chronic condition that develops in the central nervous system, which consists of the brain, spinal cord, and optic nerves and is an autoimmune disease in which the patient's immune system attacks the body’s healthy cells and tissues. Ocrevus Inj is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets CD20-expressing B cells, reducing the number and function of B cells to inhibit MS. The initial dose is 600 mg divided into 2 intravenous infusions, followed by a single 600 mg intravenous infusion every 6 months. Ocrevus was approved by the US FDA in March 2017 for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis. At the time of its initial approval, Ocrevus was approved for twice-yearly dosing following 2 two-week induction therapies. The drug was then additionally approved in December 2020 to reduce the dosing time to 2 hours from 3.5 hours. Ocrevus is the top-selling drug for multiple sclerosis, posting sales of USD 6.27 billion (KRW 8 trillion) in 2020. The MFDS said, "We expect this drug to provide a new treatment opportunity for patients with relapsing-remitting and primary progressive MS. We will continue to do our best to ensure that treatments with sufficiently verified safety and effect are promptly supplied based on our regulatory science expertise.”
- Policy
- BIO KOREA 2024 concludes a success
- by Lee, Hye-Kyung May 14, 2024 05:48am
- BIO KOREA 2024, cohosted by the Korea Health Industry Development Institute (President: Soon-do Cha) and the Provincial Administration of Chungcheongbuk-do (Governer: Young-hwan Kim), concluded successfully on the 10th. BIO KOREA 2024, which celebrates its 19th anniversary this year, was held for 3 days at COEX in Seoul under the theme of 'The Future of Biotechnology Innovation and Global Collaboration. Pic of BIO KOREA 2024 event At the event, participants shared the trends and prospects of innovative technologies that have recently attracted attention in the biohealth industry. The event also provided opportunities for global companies, institutions, researchers, and investors needed for the successful development of these technologies to forge business partnerships. 55 countries, 707 companies, and over 30,000 people attended the event. In a congratulatory speech at the opening ceremony, Minister of Health and Welfare Kyoo-HongChosaid, "We will continue to expand R&D support, create a mega fund, support exports, and foster specialized talent for the goal of making the leap and becoming a global biohealth hub. We expect BIO KOREA to spark cooperation for open innovation for Korean innovative businesses with innovative technologies of the future generation to expand their presence in the global market.” The event included business partnering, investment fair, exhibition, and conference programs. In the business partnering program, which had been expanded due to increased demand for meetings following the participation of leading domestic and international biohealth companies, more than 1,800 meetings were held over 3 days to explore various business opportunities such as finding new partners, discussing technology cooperation and joint research, technology transfer, and investment. The number of overseas participants attending to discover excellent domestic technologies increased by about 25% from the previous year, and the number of meetings held increased by about 36% in the same period. The number of overseas companies participating in the exhibition increased by 37% , and 81 local companies from 10 countries participated in the National Pavilion and actively discussed business opportunities with domestic companies. The conference featured 11 sessions that introduced and shared the latest advances and technology trends in the biohealth industry, including next-generation drug discovery platforms, diabetes and obesity treatments, microbiomes, and global open innovation. The conference hall was filled with attendees showing great interest in the special sessions on next-generation drug discovery platforms, diabetes and obesity drugs that are gaining explosive interest and demand, and AI new drug development. KHIDI President Soon-Do Cha remarked, “Thanks to the interest and active participation of domestic and international companies, organizations, and stakeholders, the BIO KOREA 2024 has concluded smoothly. We hope that BIO KOREA will continue to serve as the largest technology and business exchange venue in Korea where Korean companies can forge global partnerships and create new business opportunities."
- Opinion
- [Reporter’s View] MFDS’ Regulatory Innovation 3.0
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS)’s announcement of the regulatory innovation tasks is now an annual event. The Regulatory Innovation 1.0, announced just two months after Oh Yu-kyoung’s appointment as the minister, focused on regulations that need system improvements. Since 1.0 was criticized for not considering citizens’ opinions, 2.0 announced tasks, including managing digital safety, increasing consumer and small business benefits, and supporting future businesses. What about the implementation rate? The Regulatory Innovation 1.0, which included 100 tasks in three fields as part of the 'Improvement of Safety and Enhancement of Convenience for Health Functional Food,' had 88% implementation rate. 'Regulatory Innovation 2.0 Tasks for Food and Drug' solved 65 out of 80 tasks in five fields, showing 81.3% implementation rate. Both projects achieved over 80% implementation rate in a year. On May 2, the Regulatory Innovation 3.0 was announced. Unlike previous regulatory innovation announcements that felt like a mandatory annual event, 3.0 was different. Previous announcements lacked innovative tasks related to pharmaceuticals despite their intentions to include both food and drugs. While 1.0 and 2.0 merely updated old regulations, 3.0 aimed to solve regulations essential to the field. 3.0 included regulatory innovation tasks that would meet the needs of the pharmaceutical industry. After the Regulatory Innovation 3.0 announcement, the MFDS also provided a separate session for the pharmaceutical industry, sharing 3.0’s policy and agenda related to the field of pharmaceuticals. This year, there will be significant changes to the GMP evaluation policy, the department of approval, the clinical trial system, and the post-management of drugs. After the 3.0 announcement, there was significant interest from the pharmaceutical industry regarding the revision of requirements for registering APIs. The GMP evaluation for APIs will be replaced with documents proving the country of origin and PIC/S countries. The MFDS is already discussing internally to revise the regulation related to GMP within this year. They will announce the legislation this month and set a goal to implement the revision by December after hearing experts’ opinions and the review by the Office for Government Policy Coordination. The revision will be made so that facility audits will be substituted with submitting documents for GMP evaluation of APIs starting next year. There were doubts when Regulatory Innovation 1.0 was announced three years ago, but now the industry looks forward to the announcement of 4.0.
