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Elevation Oncology’s Claudin 18.2 Targeting ADC Earns FDA Fast Track Designation for Gastric Cancer
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Elevation Oncology, Inc. (NASDAQ: ELEV), a biopharmaceutical company based in the U.S., has announced that it has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational therapy EO-3021 (SYSA1801). This antibody-drug conjugate (ADC) targets Claudin 18.2 and is being developed for the treatment…
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Beijing Bohui Innovation and BOAOVAX End Collaboration on Rabies Vaccine Development
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Beijing Bohui Innovation Biotechnology Group Co., Ltd. (SHE: 300318), a biopharmaceutical company based in China, has announced an agreement with domestic firm BOAOVAX to terminate their collaboration on the development of a freeze-dried human rabies vaccine cultivated using serum-free Vero cells. As a result of this agreement, the clinical trials…
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InnoCare Pharma’s H1 2024 Revenue Boosted by Orelabrutinib, Anticipates Minjuvi Approval in 2025
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InnoCare Pharma (HKG: 9969; SHA: 688428), a biopharmaceutical company based in China, has released its financial report for the first half of 2024, highlighting a revenue of RMB 4.197 billion, marking an increase of 11.2% year-on-year. This growth was primarily driven by the rapid adoption of its key product, orelabrutinib,…
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China Medical System’s Opzelura Cream Filing for Vitiligo Accepted by NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that its market filing for Opzelura (ruxolitinib) cream for the treatment of vitiligo has been accepted for review by the National Medical Products Administration (NMPA). Opzelura is a topical Janus kinase (JAK) inhibitor designed for external use. It received approval in…
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Junshi Biosciences’ Toripalimab Secures EC Nod for Two Cancer Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received two indication approvals from the European Commission (EC) for its PD-1 inhibitor, Loqtorzi (toripalimab). This marks a significant expansion of the drug’s utility in the European Union, where it can now be used in combination…
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Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
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Huadong Medicine’s V20 Device Receives NMPA Approval for Market Launch
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, V20. The V20 is an intense pulsed light radiofrequency therapy device designed for various dermatological treatments. The V20 therapeutic…
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Winner Medical Expands Global Footprint with Acquisition of Global Resources International
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China-based Winner Medical Co., Ltd., a prominent manufacturer of disposable medical products, has announced the acquisition of a controlling stake in U.S. medical consumables firm Global Resources International, Inc. (GRI). The transaction values GRI at approximately USD 120 million for a 75.2% ownership interest. Established in 2000, GRI has an…
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AstraZeneca Launches South Korea Innovation Program with Focus on Chinese Market Expansion
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AstraZeneca plc (LON: AZN, Nasdaq: AZN), a UK-based pharmaceutical and biopharmaceutical company, is reportedly launching an innovation program in South Korea aimed at fostering innovative collaborations and facilitating entry into the Chinese market. The company is currently accepting applications for the program until October 11, with the AZ K-Bio Expressway…
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UCB’s Bimzelx Gains FDA Approval for Three Additional Autoimmune Indications
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Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted approval for Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody, in three new indications. The FDA’s approval expands the use of Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic…
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HBOW Bio’s First-in-Class Tumor Imaging Drug NC527-X Receives NMPA Clinical Trial Approval
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HBOW Bio, a precision oncology company supported by Sherpa Healthcare Partners, has secured clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug candidate NC527-X. This first-in-class near-infrared fluorescence (NIRF) tumor imaging agent is recognized as the world’s first drug to harness low oxygen pathways for…
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CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Acotec Scientific’s Heart Valve Balloon Dilatation Catheter RunFlow Wins NMPA Approval
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product RunFlow, a heart valve balloon dilation catheter. Designed for autologous valve dilation of the aorta during artificial aortic…
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AimingMed Technologies Partners with RekeyMed to Advance Biotech and Organoid Innovations
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Hangzhou AimingMed Technologies Co., Ltd., a leading organoid specialist based in China, has entered into a strategic partnership with RekeyMed Technology Co., Ltd, a company focused on regenerative medicine biomaterials. The collaboration aims to leverage the complementary strengths of both entities to foster the integration and innovative application of modern…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in U.S. Phase II Study for Port Wine Stain Treatment
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
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Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
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Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
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Haisco Pharmaceutical’s HSK21542 for Itching in Dialysis Patients Receives NMPA Review
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
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CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
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The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs and one companion diagnostic (CDx) are on track to receive priority review status. The drugs include: Novartis’ Fabhalta (iptacopan) for C3 glomerulopathy (C3G), a best-in-class specific complement factor B oral inhibitor that comprehensively controls intravascular…
