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- 2026-07-22 13:21:08
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- Alfresa launches Jenecell to expand stem-cell business in KR
- by Chon, Seung-Hyun Nov 05, 2025 06:22am
- Alfresa Group, a major Japanese pharmaceutical distribution company, has entered the Korean market with the establishment of its subsidiary Jenecell and declared its entry into the stem cell business market. Hee-seok Joo, CEO of Jenecell Alfresa Corporation announced on the 3rd that it has established Jenecell in Korea. The Alfresa Group is a Japanese healthcare company engaged in diverse businesses, including pharmaceutical distribution, operation of dispensing pharmacies, and regenerative medicine–related businesses. The group recorded annual sales of JPN 2.961 trillion (approx. KRW 28 trillion) last year. Jenecell was established to expand the group's business in the stem cell sector, which the group has identified as a next-generation growth engine. Alfresa plans to strengthen its presence in the Asian market and accelerate global expansion through Jenecell. The company appointed Hee-Seok Joo, former Vice President of Medytox, as CEO. Joo is a seasoned industry expert with 35 years of experience at Daewoong Pharmaceutical and Medytox, spanning operational roles through executive leadership. He has led regulatory affairs, pricing, PR, and marketing, and is known for his broad network and expertise across the pharmaceutical industry. Joo selected “Forever Young” as the corporate slogan, reflecting a commitment to the pursuit of eternal youth. Leveraging Korea’s advanced biotechnology infrastructure, Jenecell plans to pursue ▲regenerative medicine research, ▲stem cell and culture-media-based product development, and ▲strategic partnerships and M&A with promising domestic biotech companies. The company is accelerating recruitment talent in key functions, including R&D, marketing, and business development. Hee-seok Joo, CEO of Jenecell, said, “Leveraging the expertise and broad network built through years of experience, I plan to grow Jenecell into a global core hub in the stem cell field. Based on Alfresa’s technological capabilities and know-how, we will advance high-value product development and premium brand positioning.”
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- Vyloy gains reimb momentum...targets gastric cancer mkt
- by Moon, sung-ho Nov 05, 2025 06:22am
- After clearing reimbursement review on its second attempt, Astellas’ Vyloy (zolbetuximab) is expected to reshape the metastatic gastric cancer treatment landscape. The entry of a targeted therapy option into a market previously dominated by immuno-oncology drugs presents a dilemma for treatment selection in clinical practice. #According to industry sources on the 3rd, the Health Insurance Review and Assessment Service (HIRA) recently convened its 8th Cancer Disease Deliberation Committee to review reimbursement criteria for major anticancer drugs submitted for consideration. At this meeting, Vyloy, the first-in-class CLDN18.2-targeted therapy, successfully established reimbursement criteria, and the application will now move up for review by the Drug Reimbursement Evaluation Committee. The indication approved for reimbursement is as ‘first-line treatment, in combination with fluoropyrimidine- and platinum-based chemotherapy, for patients with unresectable locally advanced or metastatic CLDN18.2-positive, HER2-negative gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. The current treatment landscape for metastatic gastric cancer is dominated by immuno-oncology drugs. Specifically, Opdivo (nivolumab) is currently reimbursed in domestic clinical settings and is considered a first-line treatment option. Patients with PD-L1 expression levels of ‘CPS 5 or higher’ are granted Opdivo use with reimbursement. The other two options (Keytruda, Tevimbra) remain non-reimbursed. Under the recently revised partial coverage policy for combination anticancer therapies, only existing platinum and fluoropyrimidine-based chemotherapy regimens qualify for ‘partial coverage (5/100)’, while immuno-oncology drugs remain uncovered. However, Keytruda is currently undergoing price negotiations with the National Health Insurance Service for metastatic gastric cancer indications, with coverage expected in the first half of next year. However, Keytruda's situation is not so rosy. As its reimbursement criteria were set at ‘CPS 10 or higher,’ meaning its listing could actually impose greater restrictions on its use relative to Opdivo. In such a context, the industry believes that Vyloy would be sufficiently competitive if it were to be covered. Furthermore, according to the integrated analysis of the SPOLIGHT and GLOW studies presented at last year's European Society for Medical Oncology Annual Congress 2024 (ESMO 2024), the median progression-free survival (PFS) was 9.2 months in the Vyloy-chemotherapy combination group and 8.2 months in the placebo group. The median overall survival (OS) was 16.4 months in the Vyloy combination group and 13.7 months in the placebo group. Subsequent analysis of the Korean subgroup showed that the Vyloy combination group's mPFS and mOS were 12.6 months and 30.0 months, respectively. This is a marked improvement compared to the results previously published in the global study. Having passed the National Health Insurance Service (NHIS) review, if reimbursement is approved, as nearly 40% of all gastric cancer patients express Claudin-18.2, clinicians may consider between Vyloy and immuno-oncology drugs. Professor Minkyu Jung (Department of Medical Oncology) at Yonsei Cancer Hospital stated, “For clinicians, a major dilemma arises when a patient is both Claudin-18.2 and PD-L1 positive: which agent should be used first?” He added, “For patients who are Claudin18.2-positive and have a PD-L1 CPS (Combined Positive Score) between 5 and 10, the hazard ratio confirmed for Vyloy is 0.77, lower than that for immuno-oncology drugs. If reimbursement status is not a factor, many oncologists prefer using Vyloy in that patient group. He emphasized, “Claudin18.2 is a biomarker expressed in gastric and pancreatic cancers. It may be a pivotal biomarker in the entire gastric cancer treatment paradigm.”
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- 'Mounjaro' prescription now available at general hospitals
- by Eo, Yun-Ho Nov 04, 2025 06:10am
- 'Mounjaro,' which ranked No. 1 in global sales, is actively pursuing the prescription area in Korea. According to industry sources, Lilly Korea's dual GIP/GLP-1GIP/GLP-1 receptor agonist Mounjaro (tirzepatide) has passed drug committees (DC) of 66 medical institutes nationwide, including Samsung Medical Center, Kangbuk Samsung Hospital, Konkuk University Medical Center, Seoul National University Bundang Hospital, Soonchunghyang University Hospital, Ajou University Hospital, Eulji Medical Center, Chung-Ang University Hospital, and Hanyang University Seoul Hospital. Lilly Korea is pursuing an insurance reimbursement listing for the diabetes indication. With the obstructive sleep apnea indication added, the company plans to make prescriptions available at more general hospitals by the end of this year. In Korea, Mounjaro is approved as an adjunct drug to diet and exercise for improving glycemic control in adult patients with Type 2 diabetes (as monotherapy or combination therapy). It is also approved as an adjunct to a low-calorie diet and increased physical activity for chronic weight management in obese adults (initial BMI≥30kg/m2) or overweight adults (initial BMI≥30kg/m2) with at least one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).
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- Imfinzi reimb discussions at a standstill in Korea
- by Son, Hyung Min Nov 04, 2025 06:10am
- Concerns are mounting over multinational pharmaceutical companies’ market strategies as U.S. President Donald Trump’s Most-Favored-Nation (MFN) drug pricing policy moves toward implementation. If enforced, U.S. drug prices would be pegged to the lowest levels among major advanced markets — raising the risk that Korea’s comparatively low prices could be used as reference points, escalating fears of a “Korea-passing” scenario. In fact, the ripple effects of the MFN policy are becoming concrete as major multinational pharmaceutical companies like Pfizer and AstraZeneca engage in negotiations. Domestic drug prices for major new drugs are only about one-fourth of their U.S. counterparts. Consequently, concerns are mounting that multinational pharmaceutical companies may avoid the Korean market or reduce supply, inevitably leading to reduced access to new drugs. During the recent NA audit, Rep. Jia Han of the People Power Party warned, “If the MFN policy is implemented, Korea could be excluded from new drug introductions. Patients with severe illnesses could be particularly harmed.” Bile duct cancer coverage gap remains unfilled for 10 years… Urgent need for ‘Imfinzi’ listing raised ImfinziThis trend is especially critical for bile duct cancer patients, who have extremely limited treatment options. Bile duct cancer is difficult to diagnose early, with over half of patients diagnosed at metastatic stages. The 5-year survival rate for patients diagnosed with distant metastasis is only 4.1%. In 2022, the immune checkpoint inhibitor ‘Imfinzi (durvalumab)’ was approved in combination with chemotherapy as first-line treatment for bile duct cancer, offering the possibility of long-term survival. In clinical trials, Imfinzi demonstrated improved 3-year long-term survival rates compared to the control group, with even more pronounced effects observed in Korean patient cohorts. However, despite being approved over 3 years ago, reimbursement has yet to be granted. Imfinzi received a “redeliberation” verdict from the Drug Reimbursement Evaluation Committee (DREC) in September, but subsequent discussions have stalled, deepening patient anxiety. Notably, no new drugs for bile duct cancer have been reimbursed in the past decade. This stands in stark contrast to the expansion of reimbursement for immune-oncology drugs in other cancers like lung and breast cancer. Professor Changhoon Yoo of the Department of Medical Oncology at Asan Medical Center in Seoul emphasized, "Biliary tract cancer has a very poor prognosis and limited treatment options. While Imfinzi improves survival rates and quality of life, its non-reimbursed status places a heavy financial burden on patients. Patients need rapid access to this global standard of care.“ ” Strengthening compensation for innovative drugs"... attention rises on November DREC review results Experts unanimously agree that a flexible drug pricing evaluation system that reflects disease characteristics and societal needs is necessary for covering innovative treatments like Imfinzi. In the UK, considering Imfinzi was the first approved immunotherapy for primary biliary cancer as a first-line treatment, the ICER (Incremental Cost-Effectiveness Ratio) threshold was applied flexibly to determine its National Health Service coverage. The longer discussions drag on, the more unlikely reimbursement becomes due to the aftermath of MFN-driven global pricing effects. AstraZeneca Korea said it “remains committed to improving access and fulfilling all required procedures for Imfinzi’s reimbursement.” At the recent NA audit, Minister of Health and Welfare Eun-kyeong Jeong acknowledged MFN-related access risks and pledged to “improve compensation for innovative new drugs and improve patient access through expedited listing.” Consequently, attention is focused on whether discussions regarding Imfinzi's reimbursement will resume at the upcoming DREC meeting on November 6. The industry is watching closely to see if this committee meeting could mark a new turning point in treatment for bile duct cancer patients.
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- Bispecific antibodies pass reimbursement hurdle
- by Son, Hyung Min Nov 03, 2025 06:09am
- (from left) bispecific antibodies Major bispecific antibody therapies targeting hematologic cancers have successively cleared the first stage of reimbursement. With patients who have failed prior therapies desperately needing new options, attention is focused on whether these new drugs with innovative-mechanism will secure insurance reimbursement. According to industry sources on November 3, the Health Insurance Review & Assessment Service (HIRA) recently held its 8th Cancer Disease Review Committee (CDRC). At the meeting, reimbursement criteria were established for two hematologic bispecific antibodies: Janssen's 'Tecvayli (teclistamab)' and 'Pfizer's Elrexfio (elranatamab).' Multiple myeloma is a blood cancer characterized by the proliferation of abnormal plasma cells, which are created in the bone marrow, throughout the body. A relatively large number of treatments have emerged for this cancer type, with new drugs being approved for up to fifth-line treatment and beyond. Besides bispecific antibodies, various CAR-T new drugs like 'Kymriah (tisagenlecleucel)' and 'Yescarta (axicabtagene ciloleucel)' also target this disease. Due to exiting alternative like CAR-T had led to the assessment that reimbursement for bispecific antibodies would not be easy. However, limitations of CAR-T therapies include complex manufacturing processes, the time delay of over a month until administration, and the requirement for patients to maintain a certain health condition. Unlike these, bispecific antibodies are off-the-shelf anti-cancer drugs that work by simultaneously recognizing cancer cells and T-cells, activating the T-cells to indirectly eliminate the cancer cells. BCMA is a protein expressed on the surface of B cells, and CD3 is expressed on the surface of T-cells. Elrexfio and Tecvayli have a novel mechanism that induces myeloma cell death by targeting both. Elrexfio demonstrated efficacy in the MagnetisMM-3 Phase 2 study in patients who had failed three or more prior therapies. In the trial, Elrexfio showed an Objective Response Rate (ORR) of 61%, and the rate of maintained response at 15 months was confirmed to be 71%. The median Overall Survival (OS) for the Elrexfio group was 24.6 months, and the median Progression-Free Survival (PFS) was 17.2 months. Tecvayli was administered to 165 patients in the MajesTEC-1 Phase 2 study, resulting in an ORR of 63%, with a stringent Complete Response (sCR) of 32.7%, a Complete Response (CR) of 6.7%, and a Very Good Partial Response (VGPR) of 19.4%. The median time to response was 1.2 months, and the duration of response was reported to be 18.4 months. Bispecific antibodies for B-cell lymphoma also await to be reviewed bispecific antibodiesDiscussions on reimbursement for bispecific antibodies are also progressing in relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL), another type of hematologic cancer. Among these, AbbVie's 'Epkinly (epcoritamab)' passed the CDRC in July, after its reimbursement criteria were established. DLBCL is the most common B-cell lymphoma, accounting for about 40% of non-Hodgkin lymphomas, and has an aggressive nature with rapid progression. The failure rate after first-line treatment reaches about 15%, and even patients who achieve CR have a relapse rate of 25% within 18 months. Although existing CAR-T therapies are reimbursed and utilized, their application to elderly patients is limited due to treatment initiation delays and neurotoxicity (ICANS). Thus, the demand for new treatments still exists. Epkinly was evaluated in the EPCORE NHL-1 Phase 1/2 study, involving 167 patients with CD20-positive relapsed or refractory DLBCL who had received two or more prior lines of therapy. The results showed an ORR of 62%, a CR of 39%, and a median Duration of Response (DOR) of 15.5 months. bispecific antibodyAttention is also focused on the re-attempt for Roche's bispecific antibody, 'Columvi (glofitamab).' Columvi was submitted to the CDRC in December last year and July this year but failed to establish reimbursement criteria. Columvi was submitted concurrently with Epkinly in December last year; however, Epkinly succeeded in passing the CDRC hurdle in June on its second attempt. Since Columvi has expanded its indication to second-line DLBCL treatment in the U.S. and Europe, Roche may be considering a simultaneous reimbursement application for both second- and third-line settings. Columvi is a treatment with a maximum duration of 12 cycles, approximately 8 months, and has a defined end of treatment. In clinical trials, Columvi showed a CR of 40%, an ORR of 52%, and a median DOR of 26.9 months for patients who achieved CR. It also recorded a 67% CR maintenance rate at 18 months.
- Company
- Olympus to redefine BPH treatment landscape with iTind
- by Hwang, byoung woo Nov 03, 2025 06:09am
- Olympus Korea is moving to reshape the urology market with its benign prostatic hyperplasia (BPH) treatment device, “iTind.” Leveraging the advantages of its non-resection, shape-memory alloy structure, the company is highlighting key features such as sexual function preservation and rapid recovery as it pushes to expand market penetration. Olympus Korea held a press conference on the 31st to outline strategies to broaden adoption at domestic clinics and improve patient accessibility following the recognition of its new health technology. (From the left) Naeun Min (UG Marketing Cell Leader), Jeongsoo Kim (SP Unit Leader), Junsoo Lee,(SP Marketing Sub-Unit Leader) Olympus Korea strengthens urology portfolio Olympus Korea already possesses a diagnostic and therapeutic portfolio for various diseases, including cancer, through medical endoscopes, laparoscopes, and surgical equipment. Its core areas are gastroenterology, respiratory, and urology, while also providing diagnostic and therapeutic solutions in otolaryngology, surgery, and other fields. In April, Olympus Korea introduced the minimally invasive BPH treatment device ‘iTind’ to the domestic market. iTind is a temporary implantable device made from Nitinol alloy. When inserted into the prostatic urethra in a folded state, it gradually unfolds at the 5 o'clock, 7 o'clock, and 12 o'clock positions in response to body temperature, gently exerting pressure on the prostatic urethra and bladder neck. This process induces localized ischemia and tissue remodeling, widening the urinary channel. The device is removed after 5–7 days via a simple procedure, leaving no foreign material behind. Junsoo Lee, SP Marketing Sub-Unit Leader at Olympus Korea, stated, “iTind is a non-incisional treatment that creates a channel without using energy, thus avoiding tissue damage. It is a minimally invasive option that preserves sexual function while offering rapid recovery.” The first domestic procedure was performed at Kangdong Sacred Heart Hospital in April. The company noted that the simple procedure enables use even at clinic-level facilities and plans gradual site expansion. Jeongsoo Kim, SP Unit Leader at Olympus Korea, added, “Unlike resection surgery, it offers differentiated value by leaving no foreign objects in the body and enabling faster recovery. It will become a new treatment strategy that reduces the burden on both patients and clinicians.” Clinical evidence-based efficacy and safety...strengths of new health technology iTind’s clinical data simultaneously demonstrated long-term efficacy and safety. In a 48-month follow-up study of 81 patients with benign prostatic hyperplasia (BPH), the International Prostate Symptom Score (IPSS) decreased by 45.3%, and maximum urinary flow rate (Qmax) increased by 114.7%. A 12-month follow-up multicenter study (120 patients) confirmed a 54.9% reduction in IPSS and a 106.6% increase in Qmax, with no reports of sexual dysfunction or ejaculation disorders. Naeun Min, UG Marketing Cell Leader at Olympus Korea, stated, “Long-term benefits have been confirmed overseas, and early domestic procedure cases show high patient satisfaction. There is no residual material in the body and no tissue deformation, reducing the burden of repeat procedures.” In this regard, Olympus disclosed on-site feedback from clinicians, noting that patients reported improved urination and a rapid return to daily life after the procedure, indicating high initial satisfaction. iTIND was officially designated as a new health technology by the Ministry of Health and Welfare in May last year and is currently used in 23 countries, including the US, Europe, and Korea. It is also listed in the American Urological Association (AUA) guidelines for benign prostatic hyperplasia (BPH), securing treatment evidence. Confidence in market expansion...“Will enhance patient accessibility to spread treatment value” According to statistics from the Health Insurance Review and Assessment Service, the number of BPH patients in Korea reached 1.61 million in 2024, a roughly 24% increase compared to five years ago (1.3 million in 2019). Pic of iTindOf these, 98% are managed with medication, driving rapid growth in demand for the minimally invasive surgical therapies (MIST) category, which bridges the gap between drugs and surgery. Currently, iTind is a non-reimbursed procedure, leading to cost variations between hospitals. This means that even with good technology, cost limitations can create access barriers. Lee noted, “Although non-reimbursed, the cost is roughly half that of existing minimally invasive procedures, improving accessibility. It’s a realistic option for patients delaying surgery or struggling with drug side effects.” In the long term, Olympus Korea is focusing on expanding adoption primarily in clinics and delivering patient-tailored treatment solutions. Lee added, “We will continue education and awareness efforts to position iTind as a low-burden treatment option. Expanding access and delivering the clinical value of iTind will be our key priorities.” Kim concluded, “Olympus Korea is expanding its medical device portfolio beyond cancer treatment to enhance patient quality of life. Beginning with iTind, we will continue delivering innovative solutions in urology and minimally invasive care.”
- Company
- Samsung Bioepis wins second trial in Eylea patent dispute
- by Kim, Jin-Gu Nov 03, 2025 06:08am
- Samsung Bioepis has overturned a prior loss and secured victory in the second-instance trial on invalidating the formulation patent for Eylea (aflibercept). The ruling strengthens expectations that commercial sales of its Eylea biosimilar ‘Afilivu’ may resume. According to industry sources on the 31st, the Patent Court on Oct. 30 ruled in favor of Samsung Bioepis in its lawsuit seeking invalidation of Regeneron’s registered patent. This patent pertains to the composition of Aflibercept. It centers on formulation technology to ensure stable preparation of aflibercept, the main component of Eylea, at high concentrations (40-50mg/mL) as a ‘VEGF antagonist formulation suitable for intravitreal administration’. Samsung Bioepis filed a patent invalidation trial in December 2022. In October last year, the Intellectual Property Trial and Appeal Board (IPTAB) partially dismissed and partially rejected the petition, siding with Regeneron. Following the IPTAB ruling, domestic sales of Samsung Bioepis’ biosimilar Afilivu were suspended in Korea. Based on that decision, Regeneron had filed both a main patent-infringement lawsuit and a preliminary injunction request for sale suspension, and the court granted the injunction in May this year. Samsung Bioepis contested this, filing a lawsuit with the Patent Court to overturn the IPTAB ruling. One year later, the Patent Court reversed the earlier decision and ruled in favor of Samsung Bioepis. As a result, prospects are rising that Afilivu sales may resume. Because the preliminary injunction relied on the IPTAB decision, observers expect the injunction may now be lifted following the Patent Court ruling. The company is also seen gaining a strategic advantage in its broader legal battle with Regeneron. In addition to this invalidation lawsuit, Samsung Bioepis has appealed an earlier loss in the injunction case. The main patent infringement lawsuit is ongoing at the first-instance level.
- Company
- "Kisqali's adjuvant therapy, results from the NATALEE study"
- by Hwang, byoung woo Nov 03, 2025 06:07am
- The 5-year follow-up results of the NATALEE study, unveiled at the European Society for Medical Oncology (ESMO Congress 2025), are drawing significant attention. The data suggest the potential for further widening of the long-term survival curves across a broad patient population, including lower-risk groups such as node-negative patients. This evidence is evaluated as expanding the potential for 'complete remission access' in early breast cancer treatment. Im Seock-Ah of Seoul National University Hospital's Division of Hematology-Medical Oncology assessed that "Patients who are node-negative (N0) or have 1-3 positive nodes often relapse at 5th-7th year," and said, "The preventive effect in this late-relapse patient group will further widen the long-term survival gap." "3-year dosing design, clear evidence for inhibiting early recurrence" Im Seock-Ah of Seoul National University HospitalHormone Receptor-positive (HR+) / HER2-negative (HER2-) breast cancer is known to account for approximately 70% of all breast cancers. Furthermore, it is reported that one-third of stage 2 patients and over half of stage 3 patients experience recurrence even after the standard Endocrine Therapy (ET). The NATALEE study is a Phase 3 clinical trial evaluating the long-term recurrence prevention effect of Kisqali (ribociclib, 400mg, 3 weeks on/1 week off) combination therapy compared to non-steroidal aromatase inhibitor (NSAI) monotherapy in 5,101 patients with high-risk stage 2-3 HR+/HER2- early breast cancer. Regarding Kisqali's adjuvant therapy design, Professor Im explained, "The peak of recurrence is most pronounced between 2 and 3 years post-surgery. Continuing treatment for three years to cover this period has clear clinical evidence." She stated, "We have pharmacodynamic data showing that target inhibition is possible even at the 400mg dose, and the suppression of early recurrence is the key factor that widens the gap between the future iDFS and OS curves." The current Hazard Ratio (HR) in the NATALEE study is around 0.8, already indicating a positive outcome. Professor Im assessed that the study is following the same trend as the monarchE study of Verzenio (abemaciclib), which demonstrated improvement in Overall Survival (OS) in its 7-year follow-up analysis. Professor Im emphasized, "As the follow-up of the NATALEE study continues, OS improvement will clearly become visible within 3-4 years." She stressed, "Even an absolute benefit of 2-3% in adjuvant therapy is clinically significant, and the large-scale design of breast cancer studies is intended to secure this statistical power." "Reducing non-reimbursement burden... high economic acceptance" Professor Im also mentioned that patient access to Kisqali in clinical practice is relatively high, although it is currently non-reimbursed. She said, "Novartis is trying to improve price accessibility, and some patients can receive assistance from private insurance," and added, "The perception of it being a 'high-cost new drug' has decreased since it has been used for over seven years in metastatic breast cancer." Professor Im believes that patients view the cost not as spending millions of KRW to live a few more months with metastatic cancer, but as investing a significantly smaller amount to 'live a healthy life forever.' This perspective results in a relatively high rate of patients choosing the drug in clinical practice. However, the patient burden due to the non-reimbursed status still exists. Professor Im also shared her view that simply differentiating between overlapping patient populations when future reimbursement is applied would not be desirable. She emphasized, "Since there are patients who need to switch to Kisqali due to side effects from abemaciclib, or vice versa, the system should allow for flexible patient choice based on individual circumstances." She stressed, "Restrictions like 'you can't use this because an alternative drug exists' ultimately limit patient freedom. The system should be more open based on scientific evidence." Finally, Professor Im concluded by stressing the importance of 'precision medicine' as the future direction for breast cancer treatment, alongside discussions on treatment access. She stated, "Although breast cancer treatment is nearing a cure, there is a need to precisely differentiate the biological differences between the patient group that rapidly progresses early on and the long-term survival group." Professor Im also pointed out, "Genomic testing and biomarker analysis are the answers, but since they are not covered by insurance, the patient burden reaches 80%." He added, "Genuine long-term survival is only possible when medical professionals' scientific judgment is trusted and the system adopts a more flexible approach."
- Company
- JW Pharm's in-licensed drug ' Tavalisse' can be prescribed
- by Eo, Yun-Ho Oct 31, 2025 06:12am
- JW Pharmaceutical's new drug under contract, 'Tavalisse,' is now available for prescription at general hospitals. According to industry sources, immune thrombocytopenic purpura (ITP) treatment Tavalisse (fostamatinib) has passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Sinchon Severance Hospital, and medical institutes, including Incheon St. Mary's Hospital, Jeonbuk National University Hospital, and Chungbuk University Hospital. After receiving insurance reimbursement approval in July, this drug is quickly expanding its prescription areas. Tavalisse is the first Spleen Tyrosine Kinase (SYK) inhibitor approved in Korea. It has a mechanism inhibiting platelet destruction. It works by blocking the activation of Fc gamma (γ) receptors, which regulate the immune response, thereby suppressing excessive immune reactions and preventing thrombocytopenia. This drug was developed by the U.S. pharmaceutical company Rigel Pharmaceuticals and obtained U.S. FDA approval in 2018. Tavalisse was designated as an orphan drug in the United States (2015), Japan (2020), and Korea (2021). In 2018, Japan's Kissei Pharmaceutical secured the development and commercialization rights for Japan, China, Korea, and Taiwan from Rigel Pharmaceuticals. Consequently, JW Pharmaceutical signed a license-in agreement with Kissei Pharmaceutical in 2021 for domestic development and sales rights. According to the Korean Society of Hematology's ITP Clinical Practice Guidelines, corticosteroids and immunoglobulins are recommended as first-line treatments. If ITP persists long-term, splenectomy or thrombopoietin receptor agonists (TPO-RAs) are used as second-line treatments. However, some patients do not achieve sufficient efficacy with existing treatments, necessitating the development of a new treatment option. Tavalisse can serve as an alternative for these patients. Meanwhile, Tavalisse is reimbursable for adult patients with chronic immune thrombocytopenia who are refractory to corticosteroids and immunoglobulins. The reimbursement criteria apply to patients with a platelet count leq 20,000/㎕ or with a platelet count of 20,000 to 30,000/㎕ who also have clinically significant bleeding (such as central nervous system disease, gastrointestinal bleeding, or ocular bleeding).
- Company
- Lotte Biologics·SK Pharmteco jointly target global ADC mkt
- by Cha, Jihyun Oct 31, 2025 06:12am
- Letter of Intent signing ceremony between Lotte Biologics and SK Pharmteco (Source: Lotte Biologics) Lotte Biologics (CEO James Park) and SK Pharmteco (CEO Joerg Ahlgrimm) announced on the 30th that they have signed a Letter of Intent (LOI) for strategic business collaboration to strengthen their competitiveness in the global Antibody-Drug Conjugate (ADC) market. The signing ceremony took place at the Lotte Biologics booth at ‘CPHI Worldwide 2025’, the world's largest pharmaceutical and biotech industry held in Frankfurt, Germany. Executives from both companies, including James Park, CEO of Lotte Biologics; Yoo-Yeol Shin, Head of Global Strategy; Joerg Ahlgrimm, CEO of SK Pharmteco; and Andrew Penny, CCO. Through the collaboration, the two companies plan to jointly provide an integrated, one-stop CDMO service based on various ADC-specialized solutions to potential customers in the global market. Lotte Biologics will leverage its cGMP manufacturing capabilities and global quality competitiveness at the Syracuse Bio Campus in the U.S. to provide ADC-specific CDMO services from API manufacturing to conjugation. SK Pharmteco will be responsible for the chemical synthesis processes, including linkers and payloads. By optimizing and combining each company’s respective expertise, the companies aim to establish a full-cycle CDMO system, deliver customized integrated services, expand order intake through joint marketing, and secure global clients through joint marketing. Furthermore, they aim to address the clients’ overall chemical, manufacturing, and control (CMC) requirements and present an integrated technology and operational platform that minimizes gaps between development and manufacturing. Lotte Biologics expects to provide differentiated value to customers based on its credibility and quality competitiveness as a global bio CDMO. This is underpinned by its antibody conjugation production infrastructure at its Syracuse, USA facility, global client service experience, and track record of flawless FDA inspections. Lotte Biologics further explained that this agreement, leveraging the synergies of the production infrastructures in the U.S. and Europe, will also enable a strategic response to the ongoing US-driven supply chain restructuring and rising bio-reshoring demands. James Park, CEO of Lotte Biologics, said, “This collaboration represents a significant achievement as the pharmaceutical-biotech affiliates of Korea's leading companies join forces on the global stage for the first time. We will strive to secure a competitive advantage in next-generation modalities such as ADCs and demonstrate the potential of K-Bio on the global stage.” Joerg Ahlgrimm, CEO of SK Pharmteco, said, “This strategic partnership will accelerate the development of next-generation therapy, enabling both companies to deliver greater value and bring innovative new drugs to patients around the world faster.”
