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- 2026-05-04 19:44:19
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- Samsung Bioepis targets Stelara market
- by Hwang, Byung-woo Jul 01, 2024 05:47am
- Samsung Bioepis is seeking to target the Stelara (Ustekinumab) market by directly marketing its Stelara biosimilar Epyztek in Korea. The company is adding Epyztek to the list of autoimmune disease treatments it has been selling directly since March, a strategy that is expected to strengthen its marketing capabilities while increasing profitability. A view of the Samsung Bioepis building in Songdo.Samsung Bioepis will launch Epyztek, an autoimmune disease treatment, in the Korean market in July. Epyztek is a biosimilar of Stelara, Janssen’s treatment for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Epyztek was approved by the Ministry of Food and Drug Safety in April. Stelara inhibits interleukin (IL)-12/23 activity, a class of inflammatory cytokines (signal transmitters). As of 2023, its annual global product was around KRW 1.4 trillion, and domestic market sales were around KRW 41.6 billion. According to the ‘Drug Reimbursement List and Reimbursement Ceiling Table' announced by the Health Insurance Review and Assessment Service as of July 1, Epyztek is priced at KRW 1,298,290 per 45mg/0.5ml prefilled syringe. This is about 40% lower than the price of the existing original drug. Although Stelara’s price will also be reduced following the launch of the biosimilar, Epyztek still has a price advantage. Professor A, Department of Gastroenterology at a tertiary hospital in Seoul, Korea, said, "There seems to be little doubt about the effectiveness of biosimilars as prescriptions have accumulated. The financial burden of Stelara’s initial intravenous infusion may serve to lower the threshold for the introduction of its biosimilars." The biggest characteristic of biosimilars is in their lower cost compared to the original. However, in Korea, the price difference is not large due to the low patient copayment rate applied through Korea’s insurance reimbursement system, but Stelara’s characteristics may still provide competitivity for the biosimilars. Another characteristic of Epyztek is that the company sells the product directly. Since March, Samsung Bioepis has switched to direct sales of 3 autoimmune disease drugs that it had been selling in partnership with Yuhan Corp. With the exception of anticancer and ophthalmic drugs, the company’s decision to switch to direct sales is interpreted as the company’s attempt to increase the profitability of the drugs. Currently, Samsung Bioepis has about 20 domestic sales personnel for direct sales, and in March, it secured a distribution network in the domestic market by signing a pharmaceutical third-party logistics contract (3PL) with Geo-Young. In the field, the prospect is that Epyztek’ssales will depend on Samsung Bioepis' marketing capabilities and how quickly it can land in the market. An industry official said, "It is true that the marketing capabilities cannot be ignored due to the nature of biosimilars. However, given how Samsung Bioepis already has experience in selling biosimilars for autoimmune diseases, we expect sales to be directly related to how quickly the drug can land in each hospital." A Samsung Bioepis official said, “We are able to offer various treatment opportunities for patients with autoimmune diseases with the launch of Epyztek. Based on the reasonable drug price, we expect the drug to address the unmet demand in the field and contribute to saving national health insurance finances."
- Company
- Ilaris’s reimbursement imminent in Korea
- by Eo, Yun-Ho Jul 01, 2024 05:47am
- The ultra-rare disease treatment Ilaris has finally passed the final hurdle to its reimbursement in Korea. Novartis Korea recently completed drug price negotiations with the National Health Insurance Service for Ilaris (canakinumab), a treatment for hereditary periodic fever syndrome. The company was quick to accept the conditional benefit decision from the National Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee in April, and quickly finalized what was expected to be a difficult drug price negotiation process. Novartis' determination for reimbursement is notable. The company resubmitted the application and received a re-deliberation from DREC on the 4th after receiving a conditional reimbursement decision in February, but received the same results. However, the reduced scope of data requested by the government opened up the possibility of reimbursement. In February, Novartis was unable to accept the condition proposed by DREC. However, during this round of review, DREC likely requested less additional supplemental data with the conditional reimbursement approval decision, which Novartis was able to accept this time. It is also notable how the government swiftly responded to the first claim and reduced the scope of the evidence that was required for submission. Ilrais’s reimbursement agenda will be passed along to the Health Insurance Policy Deliberation Committee, after which the company anticipates that the drug will be reimbursed starting in August. Ilrais is indicated for the following diseases in Korea: ▲Periodic fever syndromes (PFS), cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial mediterranean fever (FMF) ▲Active systemic juvenile idiopathic arthritis (Systemic JIA). For CAPS, the indication can be further categorized into the following symptoms: ▲Familial cold autoinflammatory syndrome (FCAS)/ familial cold urticaria (FCU) ▲Muckle-Wells syndrome (MWS) ▲Neonatal onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous and articular syndrome (CINCA).
- Company
- GC Cell-Artiva-MSD’s 'CAR-NK' co-R&D deal terminated
- by Kim, Jin-Gu Jun 28, 2024 04:33am
- Despite the recent termination of the collaborative R&D agreement with MSD, GC Cell and Artiva will continue their collaborative research on ‘CAR-NK solid tumor treatment.’ GC Cell and Artiva Biotherapeutic’s collaborative research and development (R&D) agreement with MSD for ‘CAR-NK solid tumor treatment’ has been terminated. MSD informed Artiva Biotherapeutic, GC Cell’s U.S. subsidiary, of the contract termination. As a result, Artiva Biotherapeutic and GC Cell’s research agreement has been automatically ended. On June 25th, GC Cell announced a collaborative R&D agreement with Artiva Biotherapeutic for three treatments for CAR-NK solid tumors has terminated. In January 2021, GC Cell signed a collaborative R&D agreement with Artiva for CAR-NK cell treatment targeting solid tumors. GC Cell received an upfront payment of US$15 million (approximately KRW 17 billion) and was to receive milestone payments of up to US$966.75 million (approximately KRW 1.34 trillion). At that time, MSD joined the agreement as well. Artiva was responsible for R&D, with MSD participating as the main sponsor. GC Cell was responsible for the research aspect of Artiva’s R&D. Then, GC Cell completed the research requested by Artiva and delivered the results. However, despite this effort, MSD recently informed Artiva of the contract termination due to an internal decision. As a result, the agreement between Artiva and GC Cell was also terminated. GC Cell stated that despite the termination of the collaborative R&D agreement, with MSD participating as the main sponsor, the CAR-NK platform research conducted by GC Cell and Artiva as a collaborative effort will continue. GC Cell is collaborating with Artiva to conduct research on three candidate products, including AB-101, AB-201, and AB-202. Specifically, AB-101 is in a phase 1/2a trial in the United States. AB-201 has received IND approval for its phase 1 trial in the United States. The company is preparing to enter the U.S. clinical trial for AB-202. “The 2021 agreement was primarily led by Artiva. After the contract between Artiva and MSD was terminated, the agreement between GC Cell and Artiva automatically ended,” GC Cell’s official said. “Consequently, we are not obligated to return the upfront payment of US$15 million.“ The GC Cell official explained, “This does not mean the end of collaborative R&D of the CAR-NK platform with Artiva. GC Cell will primarily continue the R&D of the CAR-NK platform.”
- Company
- KOD will service platform for epilepsy patients next year
- by Lee, Tak-Sun Jun 28, 2024 04:33am
- A platform for epilepsy patients and healthcare professionals will soon be launched in Korea. Japan's Knock on the Door (KOD) announced in May that it has established its branch in Seoul and is preparing to launch the service next year. KOD was established in Tokyo, Japan, in 2018 with the goal of "Realizing a society where patients with intractable diseases and their families can shine and always stay true to themselves.” Hiroomi Hayashi, Representative Director of KOD, said, “To achieve this goal, we provide a platform where we work with patients with intractable diseases and their families to improve their medical care, life, and quality of life.” Specifically, KOD has built a platform for Japanese patients with intractable epilepsy. The platform includes "nanacara," an application that allows patients to record symptoms such as seizures and medication information, "nanacara for Dr.," which allows specialists to check the information recorded by patients and their families during medical visits, and "nana-medi," an online medical consultation and medication guidance service that allows patients to connect with specialists and pharmacists anywhere in the country. Director Hayashi explained, "By leveraging our accumulated data and network of patients, families, and doctors that use Nanacara, we provide solutions to pharmaceutical companies to help improve the quality of medical care for intractable diseases. We strive to create a society where high-quality medical care can be quickly accessed anywhere in Japan." Currently, there are approximately 1 million people with epilepsy in Japan. Approximately 300,000 are intractable epilepsy patients and approximately 100,000 are pediatric intractable epilepsy patients. There are about 900 epilepsy specialists in Japan, affiliated with 450 medical institutions. Currently, about 30,000 people in Japan have downloaded and used Nanacara, mainly pediatric intractable epilepsy patients and their families. This is around 30% of the affected patients in Japan. In addition, 265 of the approximately 450 medical institutions with epilepsy specialists have adopted Nanacara for Dr., which represents a 60% share. Director Hayashi said, “Through these platforms, we can now more easily and accurately measure the patients' seizure records and facilitate smoother communication with healthcare professionals in their institutions. Many patients and their families have also gained physical and mental relief with the use of our platform.” KOD began communicating with epilepsy patients and families in Korea last year. During the discussions, the company identified the need to document seizure records and rapid delivery of information amongst Korean patients as well. To address the need, KOD established a branch office in Seoul in May and is preparing to launch the service in 2025. In Korea, Nanacara will be rebranded as 'Borabora.’ Director Hayashi added, "We want to create an environment in Korea where more people can support people with epilepsy, and where people with epilepsy can live true to themselves. We hope that many people in Korea will use the platform and contribute to establishing an environment where patients can continue living a rewarding and valuable life.” KOD also participated in the International Epilepsy Congress that was held in Seoul from the 21st to the 22nd and held a booth presentation for Nanacara. During the exhibition, we received many opinions from Korean epileptologists. Building on the input, we will begin preparations to make Nanacara for Dr. available to Korean epileptologists as well. "We will also actively promote cooperation with related pharmaceutical companies that develop and provide anti-epileptic drugs in Korea. We hope our collective efforts will contribute to the development of medical care for epilepsy in Korea."
- Company
- MSD seeks to expand NIP subjects for Gardasil
- by Hwang, Byung-woo Jun 28, 2024 04:33am
- With the aim of expanding coverage of its human papillomavirus (HPV) vaccine within the National Immunization Program (NIP), MSD Korea has been working to improve its vaccine awareness. Expanding NIP coverage of the HPV vaccine is one of the hot topics on the government's agenda. In fact, it was ranked the third-most important task in the 'Establishing a Mid- to Long-term Plan for the National Immunization Program' study. MSD KoreaHowever, the fact that the government has set limits on the cost and subject is acting as an obstacle. According to the study, the issues discussed expanding NIP coverage to 'vaccination of girls under 12 years of age with Gardasil 9' and 'vaccination of boys under 12 years of age'. In the study, expanding vaccination of Gardasil 9 to 12-year-old girls ranked third in the overall priority list. However, vaccinating 12-year-old boys with Gardasil 9 was set as the sixth priority. The researchers differentiated the priority for the same vaccine by subject. Against this backdrop, MSD Korea has been emphasizing the need for HPV vaccination in both boys and girls At a conference held in late May, MSD Korea mentioned that 33 out of the 38 Organization for Economic Co-operation and Development (OECD) countries (as of April 24, 2014) have introduced NIP for male HPV vaccinations. Sei-Young Lee, Professor of Otolaryngology and Head-and-Neck Surgery at Chung-Ang University Hospital, said, "In men, HPV-related cancers and diseases on the rise globally, and their effect in increasing disease burden and reducing the quality of life are being undermined. Korea's male HPV vaccination rate is in the single digits, which is far below that of Australia and the United Kingdom, which have been actively carrying out HPV prevention programs." In this situation, MSD Korea is trying to build awareness of the need through social media activities. In addition to the top-down approach of emphasizing the need for HPV vaccination through pharmaceutical companies and academic communities, MSD is also working on a bottom-up approach, increasing awareness of the need for Garadsil’s coverage through NIP amongst vaccine recipients. The company has been promoting the need for HPV vaccination through social media outlets that are occupied by young people during the back-to-school season, coming-of-age day, etc. The key message is that both men and women need to be vaccinated. Pic of Gardasil 9An industry official said, "The ultimate aim for most vaccines is to be included in the NIP, so MSD Korea is constantly knocking on the door for expanded NIP coverage for Gardasil 9. Awareness-raising activities can be cumbersome as even social media posts are subject to advertising review, but the company seems to have recognized the need to increase awareness." According to the drug research institution IQVIA, Gardasil 9’s sales grew to KRW 72.6 billion in 2021, and to KRW 117 billion in 2022, then fell to KRW 106.4 billion last year. If the NIP is only applied to HPV vaccines vaccinated to women, and the product is switched to Gardasil 9, its sales could further decrease due to lowered supply prices. In other words, apart from including male HPV vaccinations in the NIP, the company would need to build awareness of its needs. An industry insider said, "If Gardasil 9 is included in the NIP, the government’s supply price will have to be lower than the current market price. If the NIP vaccination covers boys, the reduced price will be offset by the increased coverage. Even if MSD's best-case scenario of expanding coverage to both genders does not become realized, improving awareness would be essential for sales."
- Company
- Spinraza tops Q1 revenue in SMA mkt with KRW 17.7 billion
- by Nho, Byung Chul Jun 28, 2024 04:32am
- (From the left) Spinraxa Inj, Zolgensma Inj, and Evrysdi for spinal muscular atrophy Biogen Korea's Spinraza remains the No. 1 drug for spinal muscular atrophy (SMA) in the KRW 80 billion market. However, its performance has been somewhat sluggish due to the launch of competitors such as Roche Korea’s Evrysdi and Novartis’s Zolgensma. In terms of drug distribution performance, Spinraza's sales in Q1 of this year were KRW 17.7 billion, 9 to 14 times higher than that of Zolgensma (KRW 1.8 billion) and Evrysdi (KRW 1.2 billion). Sales of Spinraza (nusinersen sodium) were in the range of KRW 72.2 billion, KRW 61.2 billion, KRW 62.3 billion, and KRW 58.9 billion, in 2020, 2021, 2022, and 2023, respectively. Zolgensma (onasemnogene abeparvovec), which was approved in Korea in 2021 sold KRW 16.2 billion and KRW 14.4 billion in 2022 and 2023, respectively. Evrysdi (risdiplam), which was approved by the MFDS in 2020 generated KRW 600 million and KRW 1.123 billion during the same period. What is unusual is that Zolgensma exceeded last year's sales in just the first quarter of this year, while Evrysdi’s sales tend to be somewhat sluggish in terms of quarterly results alone. Spinraza (5m), Evrysdi (80ml), and Zolgensma (1 kit) are all ultra-high-priced orphan drugs and are priced at KRW 92.35 million, KRW 9.52 million, and KRW 1.98172 billion, respectively. . Spinraza can be administered directly to the central nervous system, where motor neurons are located, through intrathecal injection to deliver the treatment at the source of the disease. It can also be administered in multiple doses, making it easier to monitor clinical outcomes. Based on clinical study data and real-world evidence (RWE) accumulated over up to 8 years of treatment, the treatment has confirmed sustained efficacy and safety profile across all ages and types of patients. In addition, its reimbursement extension to patients with Type 3 SMA who have developed symptoms after the age of 3 is working in favor of the drug. As a one-shot treatment, Zolgensma works by inserting a functional replacement copy of the SMN1 gene into a carrier called a vector and delivering it to motor neuron cells in the body via intravenous infusion. The disadvantage is that it is difficult to administer multiple doses to patients who cannot be treated with a single dose.
- Company
- 'Increased' competitiveness in autoimmune diseases
- by Son, Hyung-Min Jun 27, 2024 05:47am
- The Korean biopharmaceutical industry is successfully signing license agreements of drugs for autoimmune diseases. HK inno. N, IMBiologics, and Y-Biologics have signed license agreements for their jointly developed novel drug candidates. AprilBio has also signed a license agreement for a novel drug candidate that has shown efficacy in a phase 1 trial. This is not the first time Korean companies have successfully entered into license agreements for novel drugs for autoimmune diseases. LG Chem, Voronoi, Hanall Biopharma, and Daewoong have also completed technology transfers overseas. Even after out-licensing, these treatments have demonstrated efficacy, confirming South Korea’s R&D capacity. Autoimmune diseases occur when the body’s immune system attacks healthy cells after mistakenly recognizing them as antigens rather than exterior antigens, such as germs and viruses. Since the cause of these diseases is still unknown, targeted treatments are not available. As a result, there is an unmet need for more new treatment options. According to industry sources on June 25th, HK inno. N signed a license agreement with Navigator Medicines, a U.S. new drug development company, for 'IMB-101,' a novel drug candidate for the treatment of autoimmune diseases. The contract totaled US$940 million (approximately KRW 1.3 trillion), including an up-front payment of US$20 million (KRW 27.6 billion). Navigator Medicines secured global development and sales rights through this agreement, excluding Asia. IMB-101 was jointly developed by HK inno. N and Y-Biologics in 2016, and it was transferred to IM Biologics in 2020. The current agreement was led by IM Biologics, a bioventure company established by people who worked at HK inno.N. IMB-101 is a novel bispecific antibody candidate that is designed to target both OX40L and TNF, simultaneously modulating adaptive and innate immune responses. OX40L pathway is involved in activating T cells, and TNF is a cell signaling protein involved in immune responses. Until now, no novel drugs have targeted both OX40L and TNF. IBM-101 and Sanofi’s SAR442970, in a phase 2 trial, are the only two novel drug candidates that have entered clinical trials. IM Biologics received approval from the U.S. Food and Drug Administration (FDA) to conduct Phase 1 trials for 'IMB-101' in August of last year. The company is currently conducting a Phase 1 trial. Phase 1 trial will evaluate the safety and drug tolerance of the drug in healthy adults and in patients with autoimmune diseases. AprilBio has also successfully signed a license agreement with Evommune, a novel drug development company in the United States, for 'APB-R3,' a novel drug candidate for the treatment of autoimmune diseases. The deal was valued at a total amount of up to US$475 million (approximately KRW 655 billion), including a non-refundable up-front payment of US$15 million (KRW 20.7 billion). The sales royalty will be paid separately. APB-R3 is a biologics candidate targeting interleukin (IL)-18. So far, there are no commercialized products with similar mechanisms of action. Once APB-R3 is commercialized, it will become the first-in-class. AprilBio has confirmed the drug tolerance and safety of APB-R3 in a phase 1 trial. Evommune plans to conduct a phase 2 trial of APB-R3 in the first half of next year. This marks the second time AprilBio has signed a license agreement for novel drug candidates for treating autoimmune diseases. In 2021, it out-licensed APB-A1 to Danish pharmaceutical company Lundbeck for US$448 million (approximately KRW 540 billion). APB-A1 is a novel drug candidate that inhibits CD40L.. CD40L is commonly expressed in activated T-cells due to inflammations. When T Cells’ CD40L binds to CD40 of natural killer cells, large quantities of cytokines are released. APB-A1 works by targeting CD40, inhibiting the formation of cytokine-releasing antibodies through B cells and natural killer cells. Now, UCB’s dapirolizumab and the U.S. biotech company Horizon Therapeutics’ Dazodalibep are under development with mechanisms of action similar to APB-A1. Increased out-licensing of novel drugs for autoimmune diseases…clinical trials are making good progress Clinical trials conducted by companies that have developed novel drug candidates for autoimmune diseases are going well. Hanall Biopharma is developing a subcutaneous formulation of a drug candidate for FcRn antibody therapy batoclimab (HL161). In 2017, Hanall Biopharma out-licensed HL161, a drug candidate for the treatment of autoimmune diseases, to Roivant Sciences, a Swiss company that also owns Immunovant. The company is investigating the potential of batoclimab for treating various autoimmune diseases, including myasthenia gravis (MG), thyroid eye disease (TED), immune thrombocytopenic purpura (ITP), neuromyelitis optica (NMO), and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The efficacy of batoclimab has been confirmed in a phase 2 trial, and it is currently undergoing multinational phase 3 trials. Hanall Biopharma plans to present its top-line results within this year. LG Chem is developing an autoimmune disease pipeline, ‘LC510255.’ In 2021, the company successfully out-licensed the pipeline to China’s TransThera Biosciences. The drug is undergoing a phase 2 trial involving patients with ulcerative colitis and atopic dermatitis. The drug tolerance and satey of LC510255 have been confirmed in a phase 1 trial. Daewoong Pharmaceutical is developing a novel drug called 'DWP213388' for the treatment of autoimmune diseases. DWP213388 has a bispecific mechanism of inhibiting both BTK and ITK, which are involved in activating immune cells such as B cells and T Cells. The phase 1 trial is being conducted in the United States. Daewoong Pharmaceutical has proven its potential by signing a global license agreement with Vitalli Bio of the United States for DWP213388 at the Korea-U.S. Digital and Bio-Health Business Forum, which was held in Boston, U.S., last year. The agreement amounted to US$477 million, including an up-front payment of US$11 million, excluding a royalty payment.
- Company
- New drug 'Mylotarg' for AML makes another attempt at reimb
- by Eo, Yun-Ho Jun 27, 2024 05:47am
- Pfizer Korea’s Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML). A new drug 'Mylotarg' for the treatment of acute myeloid leukemia (AML) is making another attempt to obtain insurance reimbursement listing. According to industry sources, Pfizer Korea has recently reapplied for reimbursement review for Mylotarg (gemtuzumab ozogamicin), a treatment for acute myeloid leukemia (AML). In May 2022, Mylotarg was considered for review by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). However, it received a decision of unestablished reimbursement criteria. It passed the Cancer Disease Review Committee review in October last year, but the subsequent decision was canceled. It is to be watched whether Mylotarg, which previously failed, will successfully acquire the listing this round. This drug is an antibody-drug conjugate (ADC) that can be used for the first-line treatment of newly diagnosed adult patients with CD33-positive AML. Mylotarg received approval in South Korea in December 2021. It is an ADC made of a CD33-targeting monoclonal antibody and calicheamicin. Mylotarg works in CD33-antigen-expressing cells found in 90% of all AML patients. The drug blocks the cancer cell growth and induces cell death through this mechanism. The basis of Mylotarg was a clinical trial involving 271 AML patients, aged between 50 and 70 years, who had not received any treatment before and were newly diagnosed. ALFA-0701 clinical trial of Mylotarg was conducted as an open-label, randomized, multi-center Phase 3 trial. The trial compared the conventional chemotherapy of daunorubicin plus cytarabine to the combination therapy of Mylotarg plus daunorubicin plus cytarabine. The result showed that the Mylotarg plus daunorubicin plus cytarabine combination therapy group had a median event-free survival (EFS) of 17.3 months, which was 7.8 months longer than 9.5 months of the daunorubicin plus cytarabine combination therapy group. It also reduced the risks of induction failure, relapse, or death by approximately 44%. The Mylotarg plus daunorubicin plus cytarabine combination therapy group had a median relapse-free survival (RFS) of 28.0 months, whereas the daunorubicin plus cytarabine combination therapy group had an RFS of 11.4 months, showing a significant difference of approximately 16.6 months. Furthermore, the Mylotarg plus daunorubicin plus cytarabine combination therapy group had an overall survival (OS) of 27.5 months, whereas the daunorubicin plus cytarabine combination therapy group had an OS of 21.8 months, indicating no statistical significance.
- Company
- SGLT-2 diabetes drug Jardiance outsells mkt leader Forxiga
- by Nho, Byung Chul Jun 26, 2024 05:47am
- Boehringer Ingelheim's Jardiance and AstraZeneca's Forxiga are striving for mastery of the KRW 110 billion SGLT-2 inhibitor class single-agent diabetes drug market in Korea. In the first quarter of this year, Jardiance and Forxiga generated sales in the range of KRW 11.1 billion and KRW 8.0 billion, respectively. Notably, this is a reversal of fortune for Forxiga, which had held the lead SGLT-2 class drug market for the past 5 years. In 2020-2021-2022-2023, Forxiga was ahead of second-place Jardiance with sales of KRW 32.2 billion, KRW 38.1 billion, KRW 45.4 billion, and KRW 49.9 billion, but in the first quarter of this year, Jardiance outperformed Forxiga by nearly KRW 3 billion. This is likely due to the rumor of AstraZeneca’s market withdrawal of Forxiga in Korea. While news that AstraZeneca's diabetes combinations, including Xigduo (dapagliflozin-metformin) and Sidapvia (dapagliflozin-sitagliptin), will replace the single-agent Forxiga has been around for over 2 years, Forxiga had remained the market leader. If the anticipated withdrawal of Forxiga takes place, sales of its competitor Jardiance will rise, as well as that of less-selling dapagliflozin products. Among dapagliflozin drugs, Forxiga is followed by Boryung’s Trudapa and Hanmi Pharmaceutical's Dapalon, which generated sales of KRW 2.1 billion and KRW 1.6 billion respectively last year. The reimbursement extension granted for Jardiance is also gaining attention. If Forxiga is withdrawn from the market, Jardiance will be the only product that owns 3 indications - diabetes, heart failure, and kidney - among the original drugs. If Jardiance were to gain reimbursement for chronic kidney disease, this would further expand its share in the SGLT-2 inhibitor market. However, AstraZeneca has granted HK Inno.N Forxiga’s clinical data in chronic heart failure and chronic kidney disease. In April, the indication for HK Inno.N's Dapa N Tab was extended to include chronic heart failure and chronic kidney disease. However, the outlook for Jardiance’s performance is not so rosy. A number of domestic pharmaceutical companies are developing a generic version of Jardiance with the goal of releasing it within the first half of next year. Astellas Korea, which generated sales of about KRW 3.7 billion last year, also reported to the MFDS that it will stop supplying its drug in mid-August for business reasons. In March, MSD Korea reported to the MFDS that it would supply Steglatro Tab 5 mg (ertugliflozin L-pyroglutamic acid) until May. The decision was based on declining market demand. SGLT-2 inhibitors inhibit glucose reabsorption in the kidneys, allowing sugar to be excreted in the urine, and have the advantages of being able to control blood sugar while not stimulating the pancreas, and reducing the risk of heart failure. The downside is that as sugar is excreted in the urine, patients become more prone to hypoglycemia and urinary tract infections, both of which are less common. Clinical studies have shown that dapagliflozin-based agents like Forxiga, etc. were associated with a 39% reduction in the composite efficacy endpoint, which was defined as the risk of death from worsening renal function, cardiovascular and renal disease, compared with placebo. Dapagliflozin also reduced cardiovascular death and heart failure exacerbation in chronic heart failure patients with reduced left ventricular systolic function with or without type 2 diabetes. Chronic kidney disease is a severe and progressive disease with a high risk of heart failure and cardiovascular events, and the results above indicate the potential of dapagliflozin as a new treatment option in the area. Jardiance and other empagliflozin drugs have been shown in clinical studies to reduce the incidence of cardiovascular death and hospitalization for heart failure in patients with heart failure with preserved ejection fraction who were receiving standard of care. The study is regarded as the first to show empagliflozin’s effect in patients with heart failure with preserved ejection fraction.
- Company
- Another anticancer drug 'Augtyro' set to be launched in KOR
- by Eo, Yun-Ho Jun 26, 2024 05:46am
- Augtyro (repotrectinib), an anticancer drug effective regardless of cancer types. A ROS-1 targeting lung cancer treatment called 'Augtyro' is entering the Korean market. According to the industry sources, Bristol Myers Squibb (BMS) Korea has recently applied for market approval from the Ministry of Food and Drug Safety (MFDS) for its Augtyro (repotrectinib), an anticancer drug effective regardless of cancer types. This drug has been designated as an orphan drug by the MFDS in early June. Augtyro is specifically indicated for ▲the treatment of patients with ROS-1 positive topical advanced or metastatic non-small cell lung cancer (NSCLC) ▲the treatment of patients with NTRK(Neurotrophic tyrosine receptor kinase) fusions in topical advanced, metastatic solid cancer or who have a high likelihood of severe morbidity upon surgical removals. Augtyro initially received U.S. FDA approval for the treatment of NSCLC in November of last year. Its indication for the treatment of solid cancer accompanying NTRK fusions is being processed for approval after having been designated for expedited review in February. The drug’s efficacy was confirmed through multinational Phase 1/2 TRIDENT-1 studies. The results showed that 71 patients who had not previously received TK1 treatments had an objective response rate (ORR), which was the primary endpoint, of 79% after Augtyro treatment. Progression-free survival (PFS) doubled compared to conventional targeted therapy. The ORR was defined by the percentage of patients showing decreased tumor sizes (partial response) or no more cancer symptoms (complete response) during the specified treatment period. The median duration of response (DOR) was 34.1 months. 56 patients who had previously undergone ROS1 TK1 therapy and no chemotherapy had an ORR of 38% and a median DOR of 14.8 months. The study also demonstrated the drug’s effectiveness in patients who had developed drug tolerance to previously administered targeted therapies. 56 patients with drug tolerance had an ORR of 38% and a PFS of 9 months. Notably, 17 patients who acquired G2032R mutation had an ORR of 59% and a PFS of 9.2 months. TRIDENT-1 study was 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) as the corresponding author. Meanwhile, lung cancers with ROS1 mutation account for 2% of all lung cancers. Conventional therapy includes targeted anticancer therapies that target the mutated gene. The common drugs are 'crizotinib' and 'entrectinib.' 'Repotrectinib' is gaining attention as the next-generation drug.
