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Zhejiang Huahai’s HB0034 Meets Primary Endpoint in GPP Study
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its multi-center, double-blinded, randomized, placebo-parallel controlled pivotal study for HB0034, a Category 1 biologic product for acute generalized pustular psoriasis (GPP), has achieved the primary efficacy endpoint and all secondary efficacy endpoints. Study ResultsGPP is a rare, life-threatening, systemic neutropenic…
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CStone Pharmaceuticals and SteinCares Ink Licensing Deal for PD-L1 Inhibitor in Latin America
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China-based CStone Pharmaceuticals (HKG: 2616) and Costa Rica-based drug maker and distributor SteinCares have entered into a licensing agreement. Under the terms of the agreement, SteinCares will obtain exclusive commercialization rights to CStone’s anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) in the Latin American market, including Brazil, Argentina,…
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Fosun Pharma’s 24-Valent Pneumococcal Vaccine Receives NMPA Approval for Phase I Trial
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd’s (SHA: 600196, HKG: 2196) subsidiary Fosun Adgenvax (Chengdu) Biopharmaceutical Co.,Ltd. is set to commence a Phase I clinical study for its 24-valent pneumococcal polysaccharide conjugate vaccine in China, following clearance from the National Medical Products Administration (NMPA). Vaccine ProfileThe preventative biologic product is…
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Bio-Thera Solutions Inks Licensing Deal with World Medicine for BAT2206
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China-based Bio-Thera Solutions (SHA: 688177) has entered into a licensing agreement with World Medicine, granting the Turkiye-based firm exclusive distribution and marketing rights to its BAT2206, a biosimilar version of Roche’s Stelara (Ustekinumab). Partnership DetailsUnder the agreement, World Medicine will handle the import, regulatory filing, and sales of the drug…
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Hainan Poly Pharm’s US Partner Slate Run Pharmaceuticals Collaborates with Premier on Contrast Agents
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced a significant partnership between its US partner Slate Run Pharmaceuticals and Premier, Inc. (NASDAQ: PINC), a healthcare-focused group purchasing organization (GPO) in the US. The collaboration centers on contrast agents. Partnership DetailsUnder the agreement, Premier’s members have the freedom to purchase…
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Gensaic and Novo Nordisk Team Up to Develop Cardiometabolic Therapies
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US-based AI-powered biotech Gensaic, Inc. announced the signing of a licensing and discovery cooperation agreement with Denmark-based Novo Nordisk A/S (NYSE: NVO). The collaboration, combining Novo’s deep therapeutic knowledge and drug development experience with Gensaic’s novel protein design technology, is designed to discover tissue-targeting ligands and develop new therapeutic candidates…
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MSD China Reorganizes to Boost Mature Product Lines
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Anna Van Acker, Senior Vice-President of Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) and President of MSD China, announced this week a significant adjustment to the company’s organizational structure. A new entrepreneur business unit will be established, focusing on the US giant’s mature products in the fields of infection,…
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Suzhou Abogen’s RSV mRNA Vaccine IND Approved by China’s CDE
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China-based nucleic acid drug developer Suzhou Abogen Biosciences announced that the Investigational New Drug (IND) filing for its freeze-dried respiratory syncytial virus (RSV) mRNA vaccine has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). RSV and Vaccine TechnologyRSV is a common viral…
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CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
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China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its Support Anti-tumor drugs R&D for Kids (SPARK) project within one month. This initiative marks a significant step forward in promoting the development of pediatric antitumor drugs. Project BackgroundThe SPARK project is a pilot effort in…
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BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
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BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change its name to BeOne Medicines Ltd, announced that it has received another indication approval from the US Food and Drug Administration (FDA) for its Tevimbra (tislelizumab). The PD – 1 inhibitor is now approved for…
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Organon’s 2024 Financial Report Shows Steady Growth in Women’s Health and Biosimilars
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Women’s health specialist Organon (NYSE: OGN) released its 2024 financial report, showing a 3% year-on-year (YOY) increase in revenues, excluding foreign exchange effects, to USD 6.4 billion. Global PerformanceGlobally, Women’s Health revenues rose 5% YOY to USD 1.78 billion, primarily driven by a 17% growth in Nexplanon (etonogestrel implant) sales,…
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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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Boehringer Ingelheim Appeals CNIPA’s Invalidation of Jardiance Patents
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The Intellectual Property Court of the Supreme People’s Court of China issued a notice, holding a hearing on the case of administrative dispute over the invalidity of invention patent between the appellant Boehringer Ingelheim and the appellee China National Intellectual Property Administration (CNIPA), as well as third parties of first…
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Genentech’s TNKase Approved by FDA for Acute Ischemic Stroke Treatment
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Genentech, a subsidiary of Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), announced that its thrombolytic agent TNKase (tenecteplase) has been approved by the US Food and Drug Administration (FDA) for the treatment of acute ischemic stroke (AIS) in adults. Drug ProfileTNKase, a tissue plasminogen activator, is administered as a single…
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Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
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Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia. Background and PartnershipsEisai entered into a licensing agreement with…
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Boston Scientific to Acquire SoniVie, Boosting Hypertension Treatment Portfolio
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Boston Scientific Corporation (NYSE: BSX) is set to acquire SoniVie Ltd, an Israel-based medical device company known for its TIVUS intravascular ultrasound system. The TIVUS system is designed to treat hypertensive disorders, including renal artery denervation (RDN) for hypertension, by denervating nerves surrounding blood vessels. The product is expected to…
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Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
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China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy. Drug ProfileFP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA).…
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Kyorin Pharmaceutical Licenses KRP-M223 to Novartis for Global Development
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Japan-based Kyorin Pharmaceutical Co., Ltd. announced a licensing agreement with Novartis (NYSE: NVS), granting the Swiss pharmaceutical giant exclusive global development, manufacturing, and commercialization rights to its KRP-M223. Under the agreement, Kyorin retains an option to commercialize the drug in Japan and manufacture it for the Japanese market, while Novartis…
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GSK’s Depemokimab Accepted for FDA Review as Ultra-Long-Acting Biologic
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GSK plc (LON: GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has accepted indication approval filings for its depemokimab, a monoclonal antibody (mAb) targeting IL-5, with a PDUFA target date set for December 16, 2025. The UK-based pharmaceutical giant is seeking FDA approval for the drug’s…
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Juvestar and Raziel Therapeutics Launch Phase III Study for RZL-012 in China
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Juvestar Biotech Co., Ltd., a subsidiary of China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), and Israel-based Raziel Therapeutics jointly announced the initiation of a Phase III study for RZL-012 in submental fat (SMF) reduction in China. Drug ProfileRZL-012, an injectable lipolytic drug developed by Raziel for…
