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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
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On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of…
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Paratek Pharmaceuticals to Acquire Optinose for $330 Million
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Paratek Pharmaceuticals and Optinose, Inc. (NASDAQ: OPTN) announced a definitive merger agreement on March 19, 2025. Under the terms of the agreement, Paratek will acquire Optinose, including its approved product XHANCE (fluticasone propionate), an innovative drug-device combination for the treatment of chronic rhinosinusitis (CRS) with or without nasal polyps. Transaction…
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Boji Medical’s Huasheng Transfers Glucosamine Sulfate Capsules Technology to Panlong
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On March 20, 2025, Boji Medical Technology Co., Ltd (known as Boji Biomedicals) (SHE: 300404) announced that its subsidiary, Huasheng Pharmaceutical, has signed a technology transfer contract with Panlong Pharmaceutical. The agreement involves the transfer of technology for “Glucosamine Sulfate Capsules” from Huasheng to Panlong, with a total transfer fee…
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Oxford BioTherapeutics Partners with Roche on Cancer Therapeutics Discovery
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On March 19, 2025, Oxford BioTherapeutics announced a multiyear collaboration with Roche (SWX: ROG, OTCMKTS: RHHBY) to discover novel potentially first-in-class antibody-based therapeutics for the treatment of cancer. This partnership leverages Oxford BioTherapeutics’ innovative discovery platform to identify and validate new targets for cancer therapies. OGAP-Verify Discovery PlatformOxford BioTherapeutics’ recently…
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Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
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On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients…
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CDE Announces 92nd Batch of Reference Preparations for Generic Drug Evaluation
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China’s Center for Drug Evaluation (CDE) has released the 92nd batch of reference preparations for generic quality and consistency evaluation (GQCE). This initiative is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the market. New AdditionsThe latest batch includes 33 new drugs and…
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HutchMed’s 2024 Financial Report Shows Dip in Revenue Amid Oncology Product Growth
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) released its 2024 financial report, revealing a total revenue of USD 630.2 million, marking a 25% year-on-year decline. The oncology/immune business segment reported USD 363.4 million, a decrease of 31% compared to the previous year. Oncology Product PerformanceDespite the overall decline, oncology product sales…
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Servier and Black Diamond Therapeutics Ink Global Deal for BDTX-4933
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French pharmaceutical company Servier and US-based Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) announced a strategic global licensing agreement for BDTX-4933 on March 19, 2025. This collaboration aims to advance the development of BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Drug ProfileBDTX-4933 is uniquely designed by Black Diamond to…
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NMPA Seeks Public Input on Drug Trial Data Protection Measures
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On March 19, 2025, China’s National Medical Products Administration (NMPA) released draft measures and procedures for drug trial data protection, soliciting public opinions until May 18, 2025. The initiative aims to foster drug innovation and meet public medication needs, in line with relevant pharmaceutical regulations. Data Protection FrameworkThe draft measures…
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Telix Pharmaceuticals Gains Brazilian Approval for Prostate Cancer Diagnostic Agent TLX591-CDx
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Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer. This approval allows the drug to be used in positron emission tomography (PET) for detecting prostate-specific membrane…
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Distinct Healthcare Files for Hong Kong IPO to Expand Integrated Medical Services
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Shenzhen-based Distinct Healthcare Holdings Limited, a comprehensive medical service provider with integrated online and offline offerings, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. This move marks a significant step in the company’s growth strategy and capital market expansion. Company OverviewSince its inception in…
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Pfizer Restructures China Operations to Boost Growth and Innovation
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US-based pharmaceutical giant Pfizer Inc. (NYSE: PFE) announced a significant leadership and organizational restructuring in China, effective March 18, 2025. The move aims to enhance the company’s growth and innovation capabilities in the Chinese market. Organizational ChangesThe restructuring involves merging the retail business team and national bidding team with the…
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CDE’s 2024 Annual Drug Review Report Shows Continued Growth in Regulatory Filings
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The Center for Drug Evaluation (CDE) released its 2024 annual drug review report, highlighting continued growth in drug regulatory filings. The CDE accepted a total of 19,563 filings of various types, marking a 5.73% year-on-year increase. Filings BreakdownThe filings included 17,476 for drug preparations, up 3.42% YOY, and 2,087 for…
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Everest Medicines Initiates Jiashan Plant for Etrasimod Tablet Production
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China-based Everest Medicines (HKG: 1952) announced the start of construction for a manufacturing plant in Jiashan, Zhejiang province, dedicated to producing its S1P receptor modulator etrasimod (formerly known as velsipity). The project, valued at RMB70 million (USD9.7 million), is expected to produce up to 50 million tablets of etrasimod upon…
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GE Healthcare and NVIDIA Expand Partnership to Advance Autonomous X-ray and Ultrasound Technologies
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) announced an expanded partnership with US-based chip giant NVIDIA (NASDAQ: NVDA) focused on the innovative application of autonomous X-ray technologies and ultrasound. This collaboration aims to transform medical imaging through artificial intelligence. Partnership DetailsThe expanded partnership will…
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Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy. Drug Profile and…
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Formosa Pharmaceuticals Inks Licensing Pact with Cipla for APP13007 in 11 Countries
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) announced a licensing agreement with India-headquartered Cipla Limited (BOM: 500087, NSE: CIPLA). Formosa is granting Cipla commercialization rights for its APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) in 11 countries, including India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia. Deal…
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AccurEdit Therapeutics Receives FDA Orphan Drug Designation for ATTR Treatment
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China-based AccurEdit Therapeutics (Suzhou) Co., Ltd announced receiving Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug ART001, targeting transthyretin amyloidosis (ATTR). This marks a significant milestone in the development of this innovative gene-editing therapy. Drug Profile and MechanismART001 is the first non-viral…
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Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sjögren’s Disease
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year. Mechanism…
