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- 2025-12-22 15:39:08
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- Oral contraceptive market expands
- by Whang, byung-woo Dec 23, 2024 04:19pm
- As the oral contraceptive market expands, Yaz seems to maintain its market share despite the introduction of generics. According to a report by global market research firm Research and Markets, the global oral contraceptive market is expected to grow from approximately KRW 33.8 trillion (USD 23.6 billion) in 2023 to around KRW 67.3 trillion (USD 47.1 billion) by 2028. Product photo of Yaz.The South Korean market also shows a consistent growth rate, similar to the global trend, with a market size of approximately KRW 42 billion in 2023, encompassing both prescription drugs and over-the-counter drugs. Contraceptives, which contain hormones such as estrogen and progesterone, are classified into four generations. The first-generation drugs have been withdrawn from the market due to side effects. Second- and third-generation oral contraceptives are available as over-the-counter medications and are distributed through pharmacies. The third-generation contraceptives minimize the side effects of the second-generation, such as acne, hirsutism, and weight gain. Bayer's Yaz (drospirenone/ethinyl estradiol) has the largest market share. In 2023 (based on IQVIA), the sales of Yaz amounted to KRW 17.4 billion, holding 41% of the market share and remaining as the No.1 drug in the market. After obtaining domestic approval in 2008, Yaz has been increasingly prescribed over the past 15 years. Contrary to expectations for heightened competition following the patent expiration of Yaz in 2020, it is meaningful that Yaz has maintained its status as the market leader. 5-year sales trend of Bayer The five-year sales of Yaz amounted to ▲KRW 14.4 billion in 2019 ▲KRW 15.9 billion in 2020 ▲peaked at KRW 19.8 billion in 2021, and slightly decreased to KRW 17.5 billion in 2022. Although the sales declined due to the introduction of generics, the original product seems to maintain its impact in the market. Currently, generic versions of Yaz are available as ▲Hyundai Pharm's Yaroz ▲GL Pharma's Plan-A ▲Alvogen Korea's Gvez ▲TheU Pharmaceuticals' Yamiz ▲Kwang-dong Pharm's Esleesi. Besides Yaroz generating KRW 2.1 billion last year, the rest of the generics have not had a significant impact in the market. The analysis is Yaz's impact stems from being the fourth-generation original oral contraceptive as well as having indications for various menstruation-related conditions, such as ▲dysmenorrhea ▲premenstrual dysphoric disorder, and ▲moderate acne treatment. 2023 sales report of Yaz and Yaz generics: from the top, Yaz, Yaroz, Plan-A, Gvez (unit: KRW 100 million, source: IQVIA). The number of patients with menstruation-related conditions in South Korea has been steadily increasing over the past five years. Dysmenorrhea showed an increase of approximately 85% (162,020 in 2017→299,115 in 2022), while premenstrual dysphoric disorder (PMDD) increased by approximately 34% (11,442 in 2017→15,296 in 2022). Regarding this, Bayer emphasizes that they have obtained results of Yaz from real-world studies involving 410 patients with dysmenorrhea. This study demonstrated that short-term and long-term administration of Yaz immediately relieved pain and symptoms and recovered endometrial thickness to normal. Additionally, in a real-world study conducted at 68 domestic hospitals involving 770 healthy women aged 18–50 who visited gynecologists for contraception regardless of premenstrual dysphoric disorder status, 92.3% of participants reported an improvement in premenstrual dysphoric disorder symptoms after six cycles of treatment with Yaz. Expert analysis indicates that real-world data (RWD) from various studies have impacted the prescription of the drug, considering that the contraception and menstruation-related diseases require long-term administration. "Menstruation diseases, such as dysmenorrhea, significantly impact women's lives, and the disease prevalence rate is increasing, requiring more attention to treatments," Dr. Yun Bo Hyun, Professor of Severance Hospital's Department of Obstetrics and Gynecology, said. "The disease requires long-term and frequent treatments. When choosing a treatment option, patients' conditions must be considered for potential incompatibility in combining oral contraceptives." Dr. Yun added, "Yaz has 15 years of prescription history in South Korea, and it is a treatment option with confirmed benefits of improving symptoms related to menstrual diseases and established safety based on numerous studies."
- Company
- Multidisciplinary approach required for urothelial carcinoma
- by Whang, byung-woo Dec 23, 2024 05:50am
- New drugs, such as immunotherapy, have been introduced as the first-line treatment for urothelial carcinoma, which was primarily treated with platinum-based chemotherapies. The treatment landscape for the disease is constantly evolving. As more treatment options became available, doctors are now discussing the optimal treatment for each disease stage to establish the standard therapy. Discussions about being made about curative intent, in other words remission, in the long term. Dr. Enrique Grande, professor at MD Anderson Cancer Center Madrid, and Dr. In-ho Kim, professor at Seoul St. Mary's Hospital, have discussed the treatment landscape and unmet needs of urothelial carcinoma. (From left) Dr. In-ho Kim, professor at Seoul St. Mary's Hospital and Dr. Enrique Grande, professor at MD Anderson Cancer Center Madrid Urothelial carcinoma (UC) is a type of cancer that begins in the epithelial cells lining the urinary tract and accounts for approximately 90% of all bladder cancer diagnoses, making it the most common form of bladder cancer. Unlike other cancer types, such as lung and breast cancer, where the introduction of new drugs has rapidly transformed first-line standard treatments, UC has historically been viewed as a challenging area for anti-cancer drug development, with substantial unmet needs for first-line treatment options. "The treatment landscape has been changing in the past few years. The treatments are now targeting various types of patients, including metastatic UC patients and management of surgical cycles for patients with muscle-invasive bladder cancer (MIBC)," Dr. Grande said. "The maintenance treatment Bavencio plays a significant role in the UC treatment landscape in South Korea," Dr. Kim said. "The enfortumab vedotin+pembrolizumab combination therapy and nivolumab+gemcitabine+cisplatin combination therapy have been approved as first-line treatments in South Korea, offering various treatment options for patients with UC." Additionally, significant advancements in the field have been made, including the approval of therapies such as enfortumab vedotin monotherapy and erdafitinib monotherapy for second-line or later treatments in South Korea. The first-line maintenance treatment Bavencio continues to generate sales…"Expected to play a significant role in South Korea" How are these various options utilized in clinical practice? Dr. Grande emphasizes that patients prioritize achieving treatment effects and improving their quality of life. "Patients with UC are typically heavy smokers in their 60s to 70s with accompanying chronic diseases, and the cancer is often detected before extensive metastasis has occurred," Dr. Grande said. "Treatment begins with chemotherapy to achieve therapeutic efficacy while maintaining quality of life, followed by first-line maintenance therapy options like Bavencio." Dr. Grande stressed the importance of using safe, low-toxicity treatments over long-term use, allowing patients to maintain their quality of life while receiving treatment safely. While the number of available treatment options in South Korea has increased, Bavencio as a first-line maintenance therapy still plays a critical role when considering the reimbursement in practices. Dr. Enrique Grande, professor at MD Anderson Cancer Center Madrid"Many options have been introduced to the treatment landscape for UC. However, in South Korea, Bavencio maintenance therapy continues to play a crucial role and is expected to remain a key option for a significant period," Dr. Kim said. "Bavencio is currently the only reimbursed first-line maintenance therapy option for UC in South Korea." In fact, Bavencio's data has been accumulating. Bavencio's company presented the SPADE study at ESMO Asia earlier this December, reaffirming the drug's efficacy and safety as a first-line maintenance therapy for patients with locally advanced or metastatic UC. The SPADE study is the first prospective study to evaluate the efficacy of Bavencio as a first-line maintenance therapy in the Asia-Pacific (APAC) region. Interim analysis results showed that at the 12-month final follow-up, 61 patients (67.0%) who received first-line chemotherapy treatment proceeded to Bavencio first-line maintenance therapy. Additionally, 72% of patients who received Bavencio maintenance therapy subsequently received second-line treatments. Additionally, the Bavencio study demonstrated safety through global clinical trials, showing a low incidence of adverse events during the treatment period and extending the quality-adjusted time without symptoms or toxicity (Quality-TWIST) to more than double compared to best supportive care (BSC). "A comparison between Bavencio combination therapy and optimal supportive care revealed no significant difference in the quality of life between the BSC and Bavencio combination therapy groups. These outcomes show an excellent tolerability profile for Bavencio maintenance therapy," Dr. Grande said. "Although the results were from a subgroup analysis, Bavencio as a first-line maintenance therapy used for one or two years has demonstrated significant clinical survival benefits," Dr. Grande remarked. "The proportion of patients who die within a short period is less than 10–20%, making the continuation of Bavencio as a first-line maintenance therapy after chemotherapy the optimal scenario." "Various changes to treatment options for UC…curative intent approach must be discussed" A common concern among UC treatment experts is identifying the characteristics of patient groups capable of achieving long-term survival. Dr. Kim highlighted the importance of considering both an individual’s health status and their socioeconomic environment. Dr. Kim stated that simplifying treatment sequences could improve patient tolerability rather than repeatedly administering multiple therapies over an extended period. Dr. In-ho Kim, professor at Seoul St. MaryDr. Kim said, "Palliative treatments aimed at prolonging life are important, and there are instances where patients achieve a cure while receiving maintenance therapy with treatments such as Bavencio." Adding, "I believe that for urothelial carcinoma to ultimately achieve the goal of curing cancer, the field of curative treatment must advance further." "In the current treatment landscape for UC, various novel therapies and combination regimens with different mechanisms are being introduced. However, we need more time to observe the real-world clinical effects of these newly introduced treatment options," Dr. Kim said. Additionally, Dr. Grande highlighted the importance of biomarker studies and multidisciplinary approaches to seek optimal treatment options. "We hope to establish a biomarker that can be utilized across treatment planning to surgical cycles and be used towards practices. There are many factors to consider when treating patients. A multidisciplinary approach involving urology, medical oncology, radiology, and nuclear medicine is essential," Dr. Grande remarked.
- Company
- Takeda's Firazyr reimbursable up to four doses per Rx
- by Whang, byung-woo Dec 23, 2024 05:49am
- Product photo of Firazyr Takeda Pharmaceuticals Korea announced on December 19 that the National Health Insurance reimbursement coverage for Firazyr (ingredient: icatibant acetate), a treatment for acute attacks of hereditary angioedema (HAE), has been expanded to up to four doses per prescription starting this December. According to partial revisions to the 'Coverage and Scope of Benefits (Pharmaceuticals),' as notified by the Ministry of Health and Welfare (MOHW), reimbursement coverage for Firazyr has been expanded from two to up to four doses per prescription. According to the revised criteria, patients with a history of at least three self-administrations who, in the past three months, have experienced ▲Either one or more acute attacks per month or ▲Required additional doses for an acute attack, are now eligible for reimbursement for up to four doses per prescription. Firazyr was approved in South Korea in June 2014 and has been reimbursed for adult patients since September 2018. In July 2019, the eligible age group was expanded to include pediatric patients aged two years and older, establishing a basis for quick response during emergencies across various age groups. Since March 2021, reimbursement for up to two doses per prescription has been implemented, allowing patients to better prepare for additional acute attacks. This recent reimbursement expansion reflects the need to address the limitations of previous reimbursement of up to two doses per prescription and improve treatment accessibility for HAE patients in Korea, considering the unpredictable onset and severity of acute swelling episodes. HAE patients often hesitated to use medication during initial acute swelling symptoms due to concerns about depleting their remaining treatment supply, resulting in repeated delays in addressing acute episodes. This status conflicted with international treatment guidelines, which recommend 'prompt treatment at the onset of acute swelling symptoms.' Both patients and healthcare professionals have consistently emphasized the need for improvements in the timeliness and safety of HAE disease management. In response, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service reviewed textbooks, clinical guidelines, and expert opinions comprehensively and decided to expand reimbursement for Firazyr to cover up to four doses per prescription for patients experiencing frequent acute swelling episodes or requiring additional doses. This measure has been implemented three years and nine months after the reimbursement of up to two doses per prescription. Analysis suggests that it is part of Takeda Pharmaceutical Korea's effort to provide a stable treatment environment for patients with hereditary HAE and solve unmet healthcare needs. "Expanded scope of reimbursement for Firazyr will strengthen treatment access to patients with HAE in South Korea. It is an important improvement implementing the recommendations by the international treatment guidelines," Kim Na-kyung, Takeda Korea Rare Disease Business Unit Head, said. "We are pleased to provide a stable treatment environment to patients who experience anxiety and risks associated with acute attacks due to HAE."
- Company
- LG Chem wins Zemiglo patent dispute
- by Kim, Jin-Gu Dec 20, 2024 05:46am
- Pic of Zemiglo LG Chem has won the 2nd trial of a patent dispute over the use of DPP-4 inhibitor diabetes drug Zemiglo (gemigliptin). The company was able to reverse its first trial loss and won the second trial, enabling it to prevent patent challengers from launching their generic versions early. The pharmaceutical industry's attention has now turned to another second trial. LG Chem is battling generic companies in patent court over the invalidity of its use patent. If LG Chem wins, it will make it even harder for generics to launch their generic versions of Zemiglo early. The 5th Division of the Patent Court ruled in favor of the plaintiffs in the passive scope of rights confirmation review trial filed by LG Chem against 8 generic companies, including Shin Poong Pharm. The court overturned the decision of the Patent Trial and Appeal Board and ruled in favor of the original company, LG Chem. The Zemiglo patent dispute began in May last year when generic companies filed for both passive confirmations of scope and patent invalidation at the same time. Shin Poong Pharm, Daehwa Pharmaceuticals, DongKoo Bio&Pharma, Boryung, Sam Chun Dang Pharm, Celltrion Pharm, Jeil Pharmaceutical, and Korea Prime Pharm were among the companies that filed for the judgment. Generic companies have filed two judgment requests for the same patent, signaling their intention to launch generics early. They planned to avoid or invalidate the use patent and launch generics early. In the first instance, the generic companies won. In April this year, they won the patent avoidance case, and in September, they won the invalidation case. LG Chem appealed the decision to the patent court. Upon appeal, LG Chem got the first laugh. The patent court overturned the first court's ruling that was in favor of generics and sided with LG Chem. The pharmaceutical industry's attention now turned to the company’s appeal of the invalidity judgment, which is yet to be decided. Upon. If LG Chem wins, it will likely block generic entry until 2039, when the patent expires. However, this also depends on the generic companies’ appeal to the Supreme Court and a reversal. On the other hand, if LG Chem loses, it will encourage generic companies to launch their product early. If the generic companies win and Zemiglo’s patent is invalidated, they can overcome the remaining two patents and launch Zemiglo-Zemimet generics. Quarterly prescriptions of Zemiglo and Zemimet (Unit: KRW 100million, Data: UBIST) Zemiglo is currently protected by three patents. The use patent expires in October 2039, the salt-hydrate patent expires in October 2031, and the substance patent expires in January 2030. For Zemimet (gemigliptin + metformin), there are two additional composition patents that expire in October 2033 and May 2039, respectively. Generic companies plan to overcome Zemiglo’s use patent first and then overcome the remaining patents to launch generics early in time for the expiration of its composition patent. According to the market research institution UBIST, Zemiglo-Zemimet is the top prescribed diabetes drug in the DPP-4 inhibitor class. In the third quarter of this year, Zemiglo's prescriptions totaled to KRW 10.5 billion and Zemimet's totaled to KRW 25.6 billion, up 1% year-on-year. Zemiglo and Zemimet became the leading diabetes drugs in the third quarter of last year.
- Company
- 'Vyloy' to expand treatment options for gastric cancer
- by Whang, byung-woo Dec 19, 2024 05:52am
- Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics. As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the early next year when it launches as non-reimbursed. Vyloy logoVyloy is the first and only Claudin-18.2-targeted treatment. A monoclonal antibody that is designed to work by binding to It binds to Claudin-18.2, a protein expressed in the stomach. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' It is gathering attention from experts since a new targeted treatment option for stage 4 gastric cancer has emerged decades after the introduction of 'trastuzumab'-based therapy for HER2-positive patients. At the Korean Society of Medical Oncology-American Association for Cancer (AACR) joint symposium held last month, two accounts of Phase 3 clinical trials were presented. The SPOTLIGHT and GLOW studies, which conducted sub-group analysis of Korean patients, show that the drug has reduced the risk of death by half in patients with locally advanced and metastatic gastric cancer. The Vyloy group had a median progression-free survival (PFS) of 12.8 months compared to 8.1 months of the placebo group, which shows that both groups had longer PFS than all patient groups. 12‧24 months PFS for the Vyloy group were 53% and 30%, and those for the placebo group were 32% and 23%. Additionally, the Vyloy group had a median overall survival of 30.0 months, twice longer than the 15.8 months of the placebo group. 12‧24 months overall survival for the Vyloy group was 78% and 54%, whereas those for the placebo group were 65% and 34%, demonstrating that the Vyloy group's death risk was lower by 50%. "The introduction of Vyloy, targeting the new biomarker for gastric cancer Claudin-18.2, will bring paradigm shift of the treatment outcome of locally advanced or metastatic gastric cancer with limited treatment options until now in South Korea," Dr. Keun-Wook Lee, Professor in the Department of Oncology at Seoul National University Bundang Hospital. The drug's clinical application in South Korea was likely to be delayed as a companion diagnostic (CDx) used to diagnose Claudin-18.2 has been considered for assessment as a new health technology. However, the drug is categorized as having 'companion diagnostic pricing (Level 1).' "The pathology department states that Level2 companion diagnostic pricing is needed for the drug that requires companion diagnostic. However, now, patients can be readily treated with the drug as Level1," Professor A from a tertiary general hospital, who requested to remain anonymous, said. In other words, If Vyloy's companion diagnostics had been assessed as a new health technology, the drug's entry into the domestic market would have been delayed by over one year. However, such concerns have now been resolved. Clinical anticipates Vyloy's prescription to be made in early 2025 when Vyloy launches in South Korea. "Diagnosis reveals that Claudin-18.2 is more frequent than expected with 3-4 individuals out of 10 new patients," Professor A said. "We expect the drug to be in stock by the end of January or February. Its use in patient treatment is expected to be higher."
- Company
- Kuhnil signs licensing agreement with Mochida
- by Whang, byung-woo Dec 18, 2024 05:55am
- Kuhnil Pharm announced on the 16th that it has signed a sales partnership agreement for Epadel, an original version of the highly purified eicosapentaenoic acid (EPA) ethyl ester formulation, with Mochida Pharmaceutical in Japan. Founded in 1913, Mochida Pharmaceuticals is a leading Japanese innovative pharmaceutical company that has played a leading role in the development of high-purity omega-3 fatty acid products. Epadel (generic name: icosapent) is a highly purified EPA ethyl ester formulation developed by Mochida as the world's first medical drug. The drug is indicated for hyperlipidemia and ulcer, pain, and chilliness associated with arteriosclerosis obliterans in Japan. Through this agreement, Kuhnil Pharm will own exclusive development and marketing rights to Epadel in Korea. Epadel has demonstrated an effect in preventing cardiovascular disease through Japan’s EPA Lipid Intervention Study (JELIS Study). Currently, Epadel’s active pharmaceutical ingredient is supplied by Nissui Corporation, which has advanced EPA purification technology and the capacity for mass production. Han-Kuk Lee, CEO of Kuhnil Pharm said, “The agreement allows us to add a new formulation to our existing portfolio, which includes Omacor and Rosumega, which have been leading the market for hyperlipidemia treatment, and further strengthen our leadership in the Korean hyperlipidemia market. Epadel will be a great treatment option for hyperlipidemia patients in Korea.
- Company
- Celltrion launches subsidiary 'BioSolutions' for CDMO
- by Cha Jihyun Dec 18, 2024 05:55am
- Seo Jung-jin, chairman of Celltrion Group (source: virtual press conference photos).Celltrion group launches Celltrion BioSolutions, a company specializing in drug contract development and manufacturing organization (CDMO). The company aims to build a manufacturing plant and research center next year and generate sales from 2028. According to the Financial Supervisory Service on December 17, Celltrion acquired 2 million shares of Celltrion BioSolutions for KRW 10 billion. After the acquisition of shares, Celltrion will secure 100% of the shares of Celltrion BioSolutions. "We have decided to commence the CDMO business in September, considering increased demands for biological drugs globally and consistent requests for CDMO services from Korea and foreign markets," Celltrion said. "We have quickly established a corporate body and initiated establishing infrastructure, such as a manufacturing facility, and running the business." The new corporate body plans to provide services for drug development spanning all stages, including new drug candidate identification, cell culture, manufacturing development, clinical trial planning, regulatory document preparation, and commercial production. Lee Hyuk-jae, senior vice president of Celltrion, has been appointed the CEO of Celltrion BioSolutions. Lee has experience in product approval, clinical trials, and production. Based on Celltrion's experience running a contract manufacturing organization (CMO) service, Celltrion BioSolutions aims to challenge the competition. Previously, Celltrion had a history of running a CMO service in 2002. However, as the company reestablished its core value of the company as a biosimilar developer in the late 2000s, the company discontinued the CMO service. "We plan to secure production by reducing the cost of expansion based on Celltrion's experience running a drug CMO service for global pharmaceutical companies spanning all phases of the pharmaceutical business, such as various business project records, proprietary production, and approvals, and also by securing price-cost competitiveness through high production·efficiency," Celltrion said. The company is reviewing site candidates for the new corporation's production facilities. Celltrion plans to design production facilities in South Korea with a maximum capacity of 200,000 liters, beginning construction on the first plant with a 100,000-liter capacity next year. The company will continuously assess the optimal location to ensure sustainable production and supply while expanding production capacity. The investment in the new company will be funded through internal capital and external funding. Initially, Celltrion plans to allocate up to KRW 1.5 trillion of its capital to establish facilities and launch contract development (CDO) services. Following this, the company plans to secure an additional KRW 1.5 trillion in external funding to expand specialized overseas research centers and to develop next-generation modality production facilities. The company plans to place multiple large·small-scale bioreactor placements to enable mass production in the new facility. Celltrion also plans to establish production facilities for next-generation modalities, including antibody-drug conjugates (ADC), multi-antibody therapies, cell and gene therapies, and peptide-based new drugs. To expand into new modality areas, strengthen production capabilities, and enhance technological competitiveness, the company will establish specialized research centers domestically and internationally, including in the United States, Europe, and India. The company aims to offer an integrated CDMO solution through the convergence of technologies. The company expects commercial production to begin in 2028, which is expected to generate significant revenue. "Based on our know-how accumulated over 20 years, Celltrion has commenced a CDMO company that could provide customized service spanning all phases of drug development for clients," Celltrion said. "Celltrion BioSolutions will strive to provide truly end-to-end service based on cost-price competitiveness and customer-oriented policy."
- Company
- Numerous K-Bio drugs secure FDA ODD
- by Son, Hyung Min Dec 18, 2024 05:55am
- Korean pharmaceutical and biotech companies seek to enter the market for rare diseases through the orphan drug designation. Th rare disease field has a small pool of patients, but companies can obtain an exclusive status by acquiring innovative new drugs when they succeed and create high-added value. New drug candidates from various companies, including Hanmi Pharm, GC Biopharma, GI Innovation, and Rznomics, successfully obtained the U.S. Food and Drug Administration (FDA)'s Orphan Drug Designation (ODD). According to industry sources on December 16, twenty-one new drug candidates under development by Korean pharmaceutical and biotech companies received ODD from the FDA. ODD provides companies developing treatments for patients with rare and intractable diseases, which have a disease prevalence of under 100,000 population, benefits such as expedited review, tax reductions, and exclusive status for new drugs. Pharmaceutical companies, Boryung·GC Biopharma, have secured FDA's ODD in the first half of the year In the first half of this year, new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. First half-year 2024 report: new drug candidates by Boryung, Rznomics, NeoImmuneTech, SPARK Biopharma, SN BioScience, Oscotec, Ingenium Therapeutics, Dr. Noah Biotech, Hanmi Pharm, GC Biopharma, and GI Innovation have successfully obtained ODD. Boryung's BR-101801, a novel drug candidate to treat blood cancer, was the first to receive FDA ODD this year. Boryung is investigating BR-101801's potential in various blood cancers, including peripheral T-cell lymphoma and mycosis fungoides. In January, it received the approval for the treatment of angioimmunoblastic T-cell lymphoma. BR101801 is the first-in-class drug candidate to inhibit phosphoinositide 3-kinase (PI3K)γ/ δ and DNA-dependent protein kinase (DNA-PK). It can effectively induce cell death through triple target inhibition and suppress a cancer protein c-Myc. NeoImmuneTech's NT-I7 received an ODD in the treatment of pancreatic cancer. NT-I7 is a novel drug candidate that targets interleukin (IL)-7, which regulates T-cell development and function. It has been investigated for various indications. Besides the current ODD for pancreatic cancer, NT-I7 received ODDs in the treatment of CD4 lymphocytopenia (2019), multifocal leukoencephalopathy (2020), and glioblastoma (2023). A Fabry disease treatment, LA-GLA, developed jointly by Hanmi Pharm and GC Biopharma, successfully received an ODD in the United States. LA-GLA is formulated for once-per-month subcutaneous administration. Fabry disease is a type of lysosomal storage disorder (LSD) resulting from a genetic deficiency in a particular enzyme, leading to metabolic alterations. In June, GI Innovation's GI-102, a candidate immunotherapy for cancer, received FDA ODD. The company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. In the second half of this year, 11 new drug candidates received FDA's ODD In the second half of this year, eleven new drug candidates from Korean pharmaceutical and biotech companies received ODD in the United States. Second half-year 2024 report: new drug candidates by K-Bio companies, including Zymedi, Connext, iLeadBMS, HysensBio, and Rezolute, successfully received the FDA Zymedi successfully received the FDA's ODD for its antibody-drug ZMA001 in July. ZMA001 targets intractable disease, pulmonary hypertension. Pulmonary hypertension is a disease characterized by narrowing of the blood vessels in the lungs, leading to increased pulmonary blood pressure and ultimately causing heart failure. In South Korea, approximately half of the patients with pulmonary hypertension die within five years of diagnosis. While treatments such as phosphodiesterase type 5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, they only provide symptom management. More new drugs are needed. ZMA001, a human monoclonal antibody, prevents inflammatory macrophages from infiltrating the lungs, fundamentally inhibiting pulmonary hypertension symptoms from the initial stage. In preclinical animal model studies, ZMA001 demonstrated superior efficacy to existing drugs. In August, Connext's acute graft-versus-host disease (GVHD) treatment, 'CNT101,' was added to the FDA's ODD list. CNT101 is a recombinant protein that targets the TLR5 receptor expressed on epithelial and immune cells and is being developed as a treatment for acute radiation syndrome caused by radiation exposure. Connext explains that CNT101 minimizes gastrointestinal tissue damage resulting from radiation toxicity during hematopoietic stem cell transplantation, thereby preventing the onset of GVHD. In October, a Target Protein Degrader (TPD) molecular glue from iLeadBMS, Ildong Pharmaceutical's subsidiary specializing in new drug development, was designated as the FDA's ODD. iLeadBMS is developing a molecular glue that targets cyclin-dependent kinase 12 (CDK12), a protein that controls the expression of cancer-related genes. A complex formation between CDK12 and Cyclin-K is known to influence the growth and metastasis of cancer cells in refractory cancer. Earlier this year, iLeadBMS presented preclinical results at the ESMO Targeted Anticancer Therapies Congress 2024 (ESMO TAT 2024), demonstrating that its molecular glue effectively inhibits CDK12 activity and induces degradation of Cyclin-K, thereby suppressing the growth of HER2-negative gastric cancer cells. This success led to the designation of the drug as an orphan drug for gastric cancer. In December, HysensBio's treatment for amelogenesis imperfecta received ODD in the United States. Amelogenesis imperfecta is a rare genetic disorder that impairs the formation of enamel on teeth. The disease causes symptoms such as tooth sensitivity, erosion, and fractures, and currently, no effective treatment options are available. Rezolute, Handok’s US subsidiary, received the FDA ODD for its 'RZ358,' a treatment for tumor-mediated hyperinsulinism. VasThera's pulmonary arterial hypertension therapy 'VTB-10' also received the FDA's ODD this month.
- Company
- SK Plasma will exclusively distribute Janssen’s Velcade
- by Nho, Byung Chul Dec 17, 2024 05:51am
- (From the left) Seungjoo Kim, CEO of SK Plasma, Christian Rodseth, Managing Director of Janssen Korea) SK Plasma, which specializes in plasma derivatives, has secured an additional rare disease treatment for its portfolio. SK Plasma (CEO: Seungjoo Kim) announced on the 16th that it had signed an exclusive domestic distribution agreement for the multiple myeloma and mantle cell lymphoma treatment Velcade inj (bortezomib triple complex) with Jassen Korea, Johnson & Johnson’s pharmaceutical division. Under the agreement, Janssen will manufacture and supply Velcade Inj, and SK Plasma will be responsible for its distribution and marketing in Korea. With this agreement, SK Plasma now owns a portfolio of leading blood cancer treatments, including Dacogen (myelodysplastic syndromes, acute myeloid leukemia) and Velcade (multiple myeloma, malignant lymphoma). “This agreement strengthens our oncology portfolio and enables us to supply a drug that has become a standard of care for multiple myeloma patients,” said Seungjoo Kim, CEO of SK Plasma. ”We will continue to develop and introduce various treatments for rare and incurable diseases to contribute to improving the quality of life for patients in Korea.” Meanwhile, SK Plasma signed an exclusive agreement with Janssen Korea in 2023 to market and sell Dacogen Inj (decitabine), a treatment for myelodysplastic syndromes and acute myeloid leukemia.
- Company
- Celltrion receives CHMP positive opinion for 4 biosimilars
- by Chon, Seung-Hyun Dec 17, 2024 05:51am
- Celltrion announced on the 16th that the. European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorizations for its 4 biosimilar candidates. With the recommendations, Celltrion’s 4 biosimilar versions for Actemra, Eylea, Prolia, and Xgeva are expected to be approved in Europe. The biosimilars are named Avtozma, Eydenzelt, Stoboclo, and Osenvelt, respectively. Avtozma is a biosimilar version of the original Actemra, which is used to treat autoimmune diseases such as rheumatoid arthritis and giant cell arteritis. Celltrion’s biosimilar demonstrated bioequivalence and similarity to the original in a global Phase III clinical trial. The original Actemra posted global sales of approximately KRW 4 trillion last year. Eylea, the original version of Eydenzelt is used to treat ophthalmic conditions such as (wet) age-related macular degeneration (AMD), retinal vein occlusion macular edema, and diabetic macular edema. It generated global sales of about KRW 12 trillion last year. Stoboclo and Osenvelt are biosimilar versions of Prolia and Xgeva, respectively. Prolia and Xgeva are based on different doses and dosing intervals of the active ingredient denosumab. Prolia is approved for the treatment of osteoporosis and Xgeva is approved for the prevention of skeletal-related events in patients with bone metastases and the treatment of giant cell tumors of the bone. Together, Prolia and Xgeva generated KRW 8 trillion in sales last year. If Celltrion’s 4 biosimilars receive marketing authorization in Europe, Celltrion will be able to achieve its goal of securing 11 products in its portfolio by 2025. Celltrion currently has received approval or recommendation for approval for 11 biosimilars: Remsima, Remsima SC, Zymfentra, Yuflyma, SteQeyma, Avtozma, Herzuma, Truxima, Vegzelma, Omlyclo, Eydenzelt, Stoboclo, and Osenvelt. The global market size for all of the original products is nearly KRW 13.5 trillion. A Celltrion official said, “It is rare for the CHMP to recommend marketing authorization of 4 products from a single company at the same time, which became an opportunity for us to demonstrate our technology and development capabilities globally. We look forward to completing the remaining marketing authorization process and commercializing our products in Europe.”
