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- 2026-06-24 09:41:47
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- Price nego for reimb of much-petitioned Enhertu complete
- by Eo, Yun-Ho Mar 18, 2024 05:49am
- The long journey of the petitioned anticancer drug ‘Enhertu’ if finally coming to an end. According to Dailypharm’s coverage, Daiichi Sankyo and AstraZeneca Korea recently completed drug pricing negotiations with the National Health Insurance Service (NHIS) for their antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) Barring any changes, the drug is expected to be covered from next month (April). After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year. Although the application passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee after re-deliberations, it took 8 months afterward for the agenda to pass the Drug Reimbursement Evaluation Committee in February. With 50,000 people signing a petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions. When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million. What is encouraging is the speed with which the negotiations were concluded. Considering how the drug’s pricing negotiations began late last month, the parties had reached an agreement way before the given deadline (60 days). There were certainly challenges that needed to be overcome during negotiations. Even with the extraordinary ICER threshold granted for the drug, the company would have had limitations in accommodating the set standards. In addition to the government and pharmaceutical companies' best efforts, to some extent, the quick progress may also be influenced by the political pressure ahead of general elections. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Enhertu, which was petitioned by 50,000 people, was presented to the Health Insurance Policy Review Committee this month and will be listed in April.
- Company
- Hanmi’s Rolvedon tops KRW 73 bil in US sales
- by Son, Hyung-Min Mar 15, 2024 05:49am
- The U.S. sales of Rolvedon (Korean product name: Rolontis), a treatment for neutropenia discovered by Hanmi Pharmaceutical, surpassed KRW 70 billion last year. Assertio plans to conduct additional clinical trials and demonstrate a competitive edge. According to the reports by Assertio on the 13th, Rolvedon generated $11 million in Q4 sales last year, showing a 38% increase from the previous quarter. Rolvedon’s sales last year amounted to $55.6 million (approx. KRW 73 billion). Rolvedon is a novel anti-cancer drug discovered by Hanmi Pharm. In 2012, Hanmi Pharm transported Rolvedon technology to U.S. Spectrum. After Assertio acquired Spectrum in April last year, it secured the licensing of sales and development of Rolvedon and lung cancer therapy poziotinib. Asserito is a pharmaceutical company specializing in developing treatments for the central nervous system and inflammation. It owns indomethacin, a nonsteroidal anti-inflammatory drug, and simvastatin, an oral film formulation. After the acquisition of Spectrum, Assertio further strengthened its pipelines. Quarterly Rolvedon sales trend (Unit: $1 million). Since its release in the United States in October 2022, Rolvedon has recorded sales of $10 million within three months. After the product launch, 70 distributors purchased Rolvedon. It was then utilized by the top three community oncology networks, accounting for 22% of the clinic market share. It continued to show strong sales up to Q2 last year. Rolvedon generated sales of $15.6 million in Q1 last year, and in Q2, it recorded $21 million (approx. KRW 28 billion), an increase of 34.6% from the previous quarter. Rolvedon’s sales in Q3 last year slowed down since its launch. It recorded $8 million in Q3 last year, a decrease of 62% from the previous quarter. According to Assertio, the demand for Rolvedon after applying the reimbursement system was below expectations. Rolvedon became available on the U.S. public reimbursement list with a permanent reimbursement J-code of 'J1449' starting last April. However, the current reimbursement system is less favorable than when Rolvedon was launched. However, Rolvedon rebounded in Q4 last year, generating $11 million in sales. “Rolvedon’s rebound was made possible by maintaining the principle of Rolvedon pricing and employing an updated commercialization strategy,” Assertio explained. “Rolvedon is expected to generate over $100 million in sales by improving patient accessibility and securing new sales channels,” Assertio stated. They added, “We will continue to conduct a clinical study of same-day administration to implement a differentiated strategy.” Conventional treatments for neutropenia, such as Neulasta, can only be administered 24 hours after cancer therapy, thereby prolonging hospitalization. Assertio plans to gain a competitive edge with its strategy of Rolvedon's same-day administration method. The Phase 1 clinical trials for same-day administration of Rolvedon are being conducted in the United States.
- Policy
- Anticipated shortage of Merck’s fertility drug ‘Gonal-F’
- by Lee, Hye-Kyung Mar 15, 2024 05:49am
- Merck has announced that 300/450/900IU Gonal-F Pen are expected to be short in supply. The shortage of Merck’s 'Gonal-F Pen,' which is the world’s first recombinant follicle stimulating hormone (r-FSH), is expected. Merck has announced that three, 300/450/900IU, of the four volumes of Gonal-F Pen approved by the Ministry of Food and Drug Safety (MFDS) are expected to be short in supply. Currently, the 150IU volume is in stock. Gonal-F, a medication for treating infertility, was approved in South Korea in 2007, following approvals in Europe in 1995 and the United States in 1997. It is used in 100 countries worldwide. Due to temporary supply delays stemming from manufacturing plant schedule, domestic supply shortages are expected from the 15th. “We are taking all necessary measures to ensure a smooth supply of our products. Once production at the manufacturing plant resumes, domestic supply is expected to return to normal after April 30th,” Merck stated. Gonal-F is a self-injectable medication used in female fertility procedures to induce follicular maturation and ovulation. Produced using the FBM (Filled-by-mass) method, it reduces batch-to-batch variability from 20% in other infertility treatments to 2%. It is primarily used for anovulation disorders, such as polycystic ovary disease (PCOD), and for ovarian stimulation and ovulation induction in assisted reproductive technology (ART). The Gonal-F prefilled pen form simplifies self-injection by providing clear dosage and administration information, reducing the burden of self-injection with a quick administration time of approximately 5 seconds. In 2020, Gonal-F imports totaled approximately KRW 10 billion when combining the sales of three dosages: 300IU at $1,473,768, 450IU at $915,755, and 900IU at $5,002,681, according to the import performance data from the MFDS. “Treatments can be substituted with Gonal-F 150IU or recombinant human follicle-stimulating hormone (FSH), which is currently approved and marketed,” Merck stated, anticipating that the supply disruption would have a minimal impact. Besides Gonal-F Pen, another medicine that contains the active ingredient follitropin alpha is Yooyoung Pharm’s 'Bemfola Prefilled Pen,' which had an import report of $1,517,095 in 2022. Additionally, Merck’s FDA-approved 'Pergoveris' is available. Pergoveris contains the active ingredients follitropin alpha, recombinant human follicle-stimulating hormone (r-hFSH), and lutropin alfa, recombinant human luteinizing hormone (r-hLH). Pergoveris can be used to treat severe infertility in patients who have deficiencies in both follicle-stimulating hormone and luteinizing hormone.
- Policy
- Gov't will specify scope of expense report details disclosed
- by Lee, Jeong-Hwan Mar 15, 2024 05:49am
- The Ministry of Health and Welfare recently met with physician and pharmacist organizations and the pharmaceutical, biotech, and medical device industries to collect opinions on setting the ‘scope of disclosure of expense reports’ that are prepared to report the expenses legally paid by pharmaceutical and biotech companies and medical devices to doctors and pharmacists. At the meeting, doctors' and pharmacists' organizations and the pharmaceutical, biotech, and medical device industries expressed their opinions that disclosing too much detailed information, such as the names of doctors and pharmacists and medical institutions, could lead to privacy violations or leakage of trade secrets. After reviewing the submitted opinions and consulting with legal experts, the MOHW plans to hold another meeting with medical and pharmaceutical organizations and the pharmaceutical, biotech, and medical device industries next month to deliver the final scope of information that will be disclosed in the expense reports. An MOHW official explained so regarding the government’s expense report disclosure system at a meeting with the press corp. The expense report on economic interests is a system that creates and stores information on items legally provided by pharmaceutical companies, medical devices, distributors, etc. to doctors and pharmacists to improve transparency and self-regulation of drug and medical device transactions. The system was introduced to Korea in 2018 and is known as the 'K-Sunshine Act' after a similar law in the United States. The scope of disclosed information in expense reports in the pharmaceutical, bio, and medical device sectors is a hot topic in the healthcare industry. This is because the disclosed information can directly or indirectly affect the activities between doctors and pharmacists and companies depending on whether the names of doctors and pharmacists, names of medical institutions and pharmacies, and license numbers are included. The MOHW is pondering over disclosing the list of doctors and pharmacists. The MOHW explained that it is seeking advice from legal experts including law firms, as there is potential for legal disputes due to the clash of private and public interests as individual and corporate information is disclosed. Under the current law, 7 categories of economic benefits are allowed to be provided to healthcare providers: sample products, support for academic conferences, support for clinical trials, product presentations, discounts under pharmacy payment terms, post-marketing surveys of medical devices, and use for performance verification before purchase. The MOHW held a meeting with providers including the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, and the Korea Medical Devices Industry Association, as well as the pharmaceutical, biotechnology, and medical device industries, to finalize the scope of the disclosed information on expense report on legitimate economic interests. At the meeting, the providers requested a conservative scope of disclosure, citing concerns about privacy violations and trade secret leaks. The ministry plans to deliver and finalize the scope of information disclosure, including whether to disclose the list of doctors, at a meeting in April after internal review and external legal advice. A MOHW official said, "For example, for conferences, only the amount supported and the name of the conference is disclosed in the expense report. For product briefings, the amount supported and the list of attending doctors are disclosed. "For medical devices, the list of doctors in charge without the amount supported is disclosed to obtain MFDS approval.” The official added, "We plan to disclose the amount of money spent to check the performance of medical devices. However, whether to disclose of the list of doctors will be finalized after internal discussions. If the pharmaceutical, biotech, and medical device industries submit their 2023 expense reports by June, the information will be disclosed on the HIRA’s website by the end of December.” “The Ministry of Health and Welfare will actively promote the disclosure of information about the expense reports by preparing pamphlets for conferences and other events to spread awareness.” Meanwhile, on December 29 last year, the MOHW first disclosed the results of a survey on expense reports on economic interest (expenses) legally provided to doctors and pharmacists in 2022 by pharmaceutical companies, and medical device distributors. At the time, a total of 11,889 pharmaceutical and medical device companies submitted data, of which 3,274 companies provided economic benefits. The amount of benefits provided amounted to KRW 808.7 billion in monetary value, and to 20.47 million items in terms of products.
- Company
- Sam Chun Dang seeks EMA approval for its Eylea biosimilar
- by Nho, Byung Chul Mar 15, 2024 05:48am
- Sam Chun Dang Pharm announced today that its European partner has simultaneously filed for approval of both vial and prefilled syringe formulations of its Eylea biosimilar (SCD411) in Europe. The application is notable as it is the first application filed in Europe following Korea for the prefilled syringe formulation. The application will undergo the EMA’s Centralised Procedure (CP). If the European Medicines Agency (EMA) reviews and approves the application, the drug will be approved simultaneously in more than 30 European countries. An official from Sam Chun Dang Pharm said, ‘The pre-filled syringe formulation is more difficult to develop than vials due to difficulty in developing the manufacturing process, including patent evasion and sterilization, but Sam Chun Dang Pharm focused all its capabilities on developing the prefilled product and was able to complete development and apply for approval before our competitors.” “We applied for the Centralized Procedure (CP) to shorten the approval period and quickly enter the market. The actual application was filed a long time ago, but it took some time for us to agree on whether to disclose the fact with our partners, which is why we disclosed it now." Sam Chun Dang Pharm filed for approval in Korea and Europe in March last year based on the final report of the Phase III clinical trial of its Eylea biosimilar and is in the process of negotiating supply contracts with partners in the U.S., Russia, and the Middle East.
- InterView
- “Solid position of JAK inhibitors despite ongoing concerns"
- by Eo, Yun-Ho Mar 15, 2024 05:48am
- Professor Seung Cheol Shim. JAK inhibitors, an 'oral drug' that initially gained attention in the field of autoimmune diseases, are now considered one of the treatment options. The first approved ‘Xeljanz (tofacitinib)’ has accumulated a ten-year prescription record. The fifth JAK inhibitor, ‘Jyseleca (filgotinib),’ is now available on the reimbursement listing. With their convenient oral administration, JAK inhibitors have emerged as favorable treatment options, providing an alternative to injectable anti-TNF inhibitors. In the medical field, JAK inhibitors are now considered a treatment option for patients with conditions such as rheumatoid arthritis and ankylosing spondylitis. “Various treatment options are now available for treating autoimmune diseases, including anti-TNF inhibitors and interleukin inhibitors. However, some patients are unresponsive to existing medicines,” Professor Seung Cheol Shim of the Division of Rheumatology at Chungnam National University Hospital stated. “JAK inhibitor, which blocks inflammatory signaling within the cell unlike biological inhibitors, can provide solutions to unmet needs,” he added. However, safety concerns remain an issue that needs to be addressed with JAK inhibitors. In 2021, JAK inhibitors faced issues related to cardiovascular side effects. The U.S. FDA issued warnings about the risks of heart disease, cancer, and other safety issues associated with JAK inhibitors. Similarly, the Ministry of Food and Drug Safety (MFDS) also distributed safety letters. Eventually, the FDA made a decision to include critical cardiovascular events, thrombosis, and mortality risks in boxed warning labels for JAK inhibitors. Although causality between the drug and adverse reactions has not been definitively proven, the safety concerns surrounding JAK inhibitors remain unresolved. “Due to these reasons, I still prefer anti-TNF inhibitors as the first-line treatment. It's not a matter of what's better. I have long experience prescribing anti-TNF inhibitors, and managing adverse reactions (such as tuberculosis) is also possible. However, while there may be hypotheses about JAK inhibitors, the exact cause remains unknown,” Shim explained. “Furthermore, considering the clear advantages of JAK inhibitors, they are often considered for relatively young patients with lower cardiovascular risks during their first medical examination,” Shim added. Some reimbursement criteria have yet to be addressed. While JAK inhibitors are expanding their indications to include atopic dermatitis, rheumatoid arthritis, and ankylosing spondylitis, there are undoubtedly still areas of uncertainty. “Due to special exemption of calculation provisions, patients who meet the reimbursement criteria have significantly reduced economic burdens. However, patients with seronegative rheumatoid arthritis still do not receive benefits. In the case of ankylosing spondylitis, reimbursement prescriptions are only possible for patients with confirmed bone damage. These issues need to be addressed,” Shim stated. The medical field has long complained about the issue of cross-medication between JAK inhibitors. “While cross-medication reimbursement is approved for ankylosing spondylitis, it is not approved for rheumatoid arthritis. The issue lies in the limited availability of data regarding JAK inhibitors in South Korea. More data on JAK inhibitors must be collected to expand reimbursement criteria,” Shim emphasized.
- Policy
- HIRA’s CDDC seeks to revise current regulations
- by Lee, Tak-Sun Mar 15, 2024 05:48am
- The current regulation that randomly selects members for each Cancer Disease Deliberation Meeting will be deleted. The measure was prepared to maintain consistency in the committee’s deliberations. In addition, the Korean Association for Lung Cancer will be added as a recommended organization given that lung cancer drugs are often on the agenda. The Health Insurance Review and Assessment Service issued a notice of the proposed amendments to the Operating Regulations for the Severe Disease Review Committee (Cancer Disease Review Committee, CDDC) on the 13th of this month. The amendments were made for the following reasons: ▲ to specify the legal grounds for establishing the committee in detail ▲ to update the committee's composition practice according to the occurrence of organizations with a low number of recommendations ▲ to change the method of selecting attendees due to the continuous occurrence of agendas for specific cancer types (to maintain consistency in deliberations by including members with continuum when organizing meetings) ▲ to amend the lack of the term of office clause for HIRA members ▲ and to strengthen expertise by adding organizations related to frequent agendas to the recommended organizations. In particular, the current random selection regulation will be removed to maintain the expertise and consistency of the committee members during meetings. Article 3, Paragraph 1 of the current regulations stipulates, "The committee shall consist of no more than 25 members randomly selected for each meeting.” However, since a variety of anticancer drugs are reviewed by the Cancer Disease Deliberation Committee, the committee decided to delete the reregulate as it may be difficult to establish consistent reimbursement standards while replacing members every time. A HIRA official said, “We are already flexibly adjusting the composition of the committee members to reflect the characteristics of the drugs, but decided to remove the regulation to maintain expertise and consistency in our deliberations.” Accordingly, the regulation will be changed to "consist of no more than 25 members, including 9 clinical experts, but may consider Appendix 2 with reference to the specialty and contents of each meeting’s agenda. Appendix 2 refers to the experts recommended by expert societies, and the Korean Lung Cancer Society has been added in the recent amendment. This is a reflection of the recent increase in the number of lung cancer treatments presented on the agenda. The composition of the committee will also be changed. The number of clinical experts recommended by the director will increase from 2 to 3, while the number of experts recommended by health-related organizations will decrease from 3 to 2. In addition, the number of reviewers for solid cancer and hematologic cancer drugs will be changed from 2 reviewers each to 2 reviewers. In addition, the wording of Article 14 regarding the disclosure of review results will be revised. Although the current regulation states that “the committee shall not disclose the results of deliberations,” when the disclosed information is deemed to negatively affect the public's right to receive reimbursement, the reimbursement policy of the Ministry of Health and Welfare, or when to harm the reimbursement order, the revised regulation leaves open the possibility of disclosure, by changing the phrase to “may not disclose the results of deliberations.” The opinion inquiry period for the proposed amendment will end on the 19th. Meanwhile, the 10th Cancer Disease Review Committee recently began its two-year term. The 10th committee consists of 40 members and is chaired by Professor Ho-Young Lim of the Samsung Medical Center.
- Company
- Yuhan’s external investments totaled KRW 85 bil last year
- by Chon, Seung-Hyun Mar 14, 2024 05:42am
- Yuhan spent a total of KRW 85 billion in external investments. By acquiring equity investments in companies across various sectors, such as biotech venture and health-functional food, Yuhan scouted for additional acquisitions to expand its business areas. According to the Financial Supervisory Service on the 12th, Yuhan made ten external investments last year. Yuhan invested a net amount of 84.7 billion in other incorporations, including three new investments and seven additional investments. Yuhan has undertaken new investments, including ProGen, Fermentec, and Meritz Suseong Global Bio No.1. Last May, Yuhan invested KRW 30 billion to acquire the biotech venture ProGen. By acquiring existing shares and issuing new shares, Yuhan invested a total of KRW 30 billion, becoming the largest shareholder of ProGen with a 38.9% stake. ProGen is a company holding a multi-specific antibody-based platform technology. Established in 1998, ProGen is an R&D-focused company that utilizes genetic engineering. In September 2022, Yuhan and ProGen signed a memorandum of understanding (MOU) for research collaboration in innovative new drug development. Yuhan and ProGen plan to jointly develop next-generation innovative bio candidates such as multi-specific antibody therapeutics. Last September, Yuhan invested KRW 5.7 billion in the health-functional food company Fermentec, acquiring a 10.0% stake. Fermentec's primary business is in the manufacturing of microbial fermenters. As of the end of 2022, Yuhan Medica holds a 42.11% stake, making it the largest shareholder. Yuhan Medica is a subsidiary of Yuhan. Yuhan invested in Fermentec to produce high-quality, low-cost probiotics. Yuhan has increased its investment in companies it already owns. At the end of last year, Yuhan acquired KRW 28.2 billion worth of shares in ImmuneOnsia. Yuhan purchased the shares in ImmuneOnsia previously held by Sorrento Therapeutics. In 2016, Yuhan established ImmuneOnsia through a joint venture with Sorrento Therapeutics, a Nasdaq-listed company. ImmuneOnsia focuses on developing immune checkpoint inhibitors targeting PD-L1 with 'IMC-001' and CD47 with 'IMC-002'. ImmuneOnsia collaborates with Yuhan Research Institute and Sorrento's antibody library to supply promising clinical candidates, maximize drug value, and engage in technology exportation. Yuhan initially invested KRW 17.8 billion at the establishment of ImmuneOnsia and later invested KRW 6 billion as a strategic investor (SI) during ImmuneOnsia's pre-IPO fundraising round in 2022, raising a total of KRW 24.5 billion. Last year, Yuhan invested an additional KRW 7 billion in AtoGen. In September 2022, Yuhan acquired AtoGen by investing KRW 10.5 billion. By purchasing 338,000 shares (52.15% ownership) held by AtoGen's largest shareholder, Tony Mori, and shares held by venture capital, Yuhan secured a 59.9% stake in AtoGen. Based on its independent development platform, AtoGen is developing microbiome therapies for various diseases, such as metabolic disorders, immune disorders, and muscular diseases. It also possesses R&D capabilities for developing health-functional food probiotic materials with specific functionalities. By acquiring AtoGen, Yuhan plans to expand its business by developing microbiome-based therapies and functional probiotics. Last December, Yuhan invested KRW 6 billion to acquire 43,550 common shares of SB BioPharm. SB BioPharm specializes in developing and manufacturing veterinary medicines and food, while Neodin BioVet. Laboratory and Zoonolab focus on conducting diagnostic tests and producing diagnostic kits for companion animals. In 2021, Yuhan purchased KRW 7 billion worth of redeemable convertible preference shares from SB BioPharm and made additional investments last year. Yuhan launched the pet care brand Wilopet in collaboration with SB BioPharm. In partnership with SB Biopharm, Yuhan plans to release various new products in pet medicines, over-the-counter medication, premium pet nutrition, and veterinary diagnostics. Last year, Yuhan invested KRW 2 billion J INTS BIO and KRW 1 billion in Aimedbio. J INTS BIO is a bio company focused on the development of novel anticancer drugs. It acquired new pipelines through a transfer agreement of two products, 'JIN-A01' and 'JIN-A02,' developed by Kwangho Lee of the Korea Research Institute of Chemical Technology and Byoung Chul Cho of the Lung Cancer Center at Yonsei Cancer Hospital. Yuhan entered into a partnership with J INTS BIO by investing KRW 20 billion each in equity in 2021 and 2022. Last May, Yuhan signed a licensing agreement with J INTS BIO for the targeted therapy ‘JIN-A04’. The technology transfer agreement has a total contract size amounting to KRW 429.8 billion, with a non-refundable upfront payment of KRW 25 billion. Yuhan invested KRW 8.5 billion in equity investments and upfront payments for technology transfer. Yuhan Pharmaceuticals invested KRW 1 billion in acquiring Aimedbio's redeemable convertible preference shares in October last year. Aimedbio is focused on developing new antibody drugs in the field of brain science. In 2021, Yuhan invested KRW 3 billion in Aimedbio, acquiring a 3.0% stake in its common stock. Furthermore, Yuhan made additional investments last year. Yuhan increased its investment in MediRama, a clinical development strategy consulting company. Over a year, Yuhan’s ownership in the stock rose from 8.1% at the end of 2022 to 15.0%.
- Policy
- MFDS starts regulatory innovation program for Big Techs
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- The Ministry of Food and Drug Safety (MFDS) announced that will be operating a ' 2024 Big Tech Company Regulatory Innovation Program’ again this year to provide continuous regulatory support to domestic digital medical device companies. Last year, the MFDS identified the exact needs of the industry through the Big Tech Company Regulatory Innovation Program and selected 5 regulatory improvement tasks in the field of AI medical devices for regulatory improvement, and this year, the program has been expanded to include not only AI medical devices but also digital medical devices and increased the number of participating companies. In addition to the Big tech companies that have previously participated in the program including KT, LGU+, Naver, Kakao Brain, and Kakao Healthcare, this year, SKT, Samsung Electronics, Samsung Fire & Marine Insurance, and Hyundai Motor Company, will be included as participants. When looking at the main business areas of the newly added companies, SKT is developing a pet AI healthcare service (X Caliber: X-ray-based animal image diagnosis assistant), while Samsung Electronics is developing wearable devices and applications to monitor blood pressure, ECG, etc. In addition, Samsung Fire & Marine Insurance is developing an application (Anyfit Plus) that provides meaningful healthcare services to health insurance subscribers, and Hyundai Motor is developing a wearable rehabilitation robot. The MFDS will hold meetings with each company from March to monitor the business progress and implementation plans of each company, discover additional regulatory improvement tasks, and share results of the MFDS’s regulatory improvement, and will hold semi-annual meetings with all big tech companies participating in the program. The MFDS said, "We expect the Big Tech Company Regulatory Innovation Program 2024 to achieve field-oriented regulatory innovation that companies can practically experience, and plan to do our best to ensure that our regulations can serve as a reference for global regulations and support the companies’ growth into leaders in the global digital medical device market.”
- Policy
- Chong Kun Dang also enters low-intensity atorvastatin mkt
- by Lee, Hye-Kyung Mar 14, 2024 05:42am
- Amid fierce competition in the hyperlipidemia drug market to develop 2nd generation ‘statin + ezetimibe’ combination drugs using low-strength statins, some low-dose atorvastatin products are also soon to enter the market. On the 12th, the MFDS approved Chong Kun Dang's ‘Lipilou Tab 5mg.’ It is a 5 mg low-strength single tablet that contains atorvastatin calcium trihydrate. This is the second single low-dose atorvastatin drug to be approved after Yuhan Corp’s 'Atorvastatin 5mg' in May last year. Chong Kun Dang owns 3 ‘Lipilouzet Tab’ combination drugs that contain atorvastatin and ezetimibe. The three contain the same dose of ezetimibe of 10 mg, with different doses of atorvastatin of 10mg, 20mg, and 40 mg. The company also owns monotherapy atorvastatin in 10mg, 20mg, 40mg, and 80mg doses as ‘Lipilou Tab,’ and the lineup has been extended with the addition of the 5mg formulation. With the approval of the low-strength monotherapy drug, Chong Kun Dang is expected to also develop a combination drug using the 5 mg atorvastatin and expand its Lipilouzet lineup. In Korea, the development of the low-dose statin-based hyperlipidemia combination drug was pioneered by Hanmi Pharmaceutical. In September 2021, Hanmi Pharmaceutical received approval for ‘Rosuzet Tab 10/2.5mg,’ a combination of rosuvastatin 2.5 mg and ezetimibe. After being released in October of the same year with reimbursement, the drug’s sales have been rapidly increasing in the market. According to the market research institution UBIST, outpatient prescriptions for Rosuzet in 2022 reached KRW 140.3 billion, up 14% year-on-year. The rising demand for low-dose rosuvastatin has prompted other companies to develop combination products based on low-dose rosuvastatin. Following Daewoong Pharmaceutical's approval of Crezet Tab 10/2.5 mg, which contains the same ingredient-dose combination as Rosuzet in August 2022, Yuhan Corp released ‘Rosuvamibe,’ HK Inno.N ‘Rovazet,’ and GC Biopharma ‘Daviduo’ in their product lineup. Yuhan Corp then introduced a low-dose(5 mg) atorvastatin product, continuing the low-dose boom in hyperlipidemia treatment that began with rosuvastatin. To date, no 5 mg low-dose atorvastatin calcium trihydrate has been granted reimbursement in Korea. With Yuhan Corp having established a foothold in the hyperlipidemia market, the addition of Chong Kun Dang’s product is expected to open up the low-dose atorvastatin market shortly.
