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Bayer AG and Meituan Deepen Partnership to Transform Skin Health Market in China
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Bayer AG (ETR: BAYN), a leading German multinational pharmaceutical and life sciences company, has expanded its partnership with Meituan’s medical and healthcare business unit, a major player in China’s delivery services. The new collaboration will concentrate on the skin health sector, with a focus on online retail, digital marketing, and…
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Changchun High & New Technology Industries Receives FDA Tacit Approval for GenSci122 Clinical Study
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Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company, has announced that it has received tacit approval from the US Food and Drug Administration (FDA) to commence a clinical study for its drug candidate, GenSci122, in patients with advanced solid tumors. GenSci122 is a small…
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Jiangsu Hengrui’s HR19042 Earns Breakthrough Designation for Autoimmune Hepatitis Treatment in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its modified drug HR19042, which targets active autoimmune hepatitis (AIH). AIH is a rare liver disease that, if untreated,…
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Eli Lilly’s Mirikizumab Shows Statistically Significant Improvement in Crohn’s Disease VIVID-1 Study
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Eli Lilly & Co. (NYSE: LLY), a leading pharmaceutical company in the U.S., has published the results of the VIVID-1 study, demonstrating the efficacy of mirikizumab in patients with moderately to severely active Crohn’s disease. The study showed that mirikizumab achieved nominally statistically significant improvements across all histological and histological…
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Humanwell Healthcare Secures NMPA Approval for Clinical Trial of HW211026 to Treat Actinic Keratosis
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate HW211026. This Category 1 chemical drug is designed to treat actinic keratosis, a skin condition caused by prolonged sun…
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Thermo Fisher Faces FDA Scrutiny Over Syringe Air Bubble Protocols at North Carolina Plant
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Thermo Fisher Scientific’s (NYSE: TMO) Greenville, North Carolina, facility has come under scrutiny after a US Food and Drug Administration (FDA) inspection revealed certain production procedure issues, including the monitoring and measurement of air bubbles within syringes, according to a Form 483 document obtained by Reuters. The inspection was part…
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United Laboratories’ TUL12101 Eye Drops Enter Phase IIa Clinical Trial for Dry Eye Syndrome
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United Laboratories International Holdings Ltd (HKG: 3933), a Hong Kong-based pharmaceutical company, has announced the enrollment of the first subject in the Phase IIa clinical study for its Category 1 drug, TUL12101 eye drops, in China. This development marks a significant step forward in the clinical evaluation of the drug.…
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3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
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3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
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Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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Beijing Aims to Build a Leading Cell and Gene Therapy Hub by 2026 with New Action Plan
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The Beijing Municipal Science & Technology Commission, in conjunction with the Administrative Commission of Zhongguancun Science Park, has unveiled the “Beijing Action Plan for Accelerating Collaborative Innovation in Medicine and Health (2024-2026)”. The plan is designed to cement Beijing’s position as a global hub for cell and gene therapy (CGT)…
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RemeGen’s Disitamab Vedotin Receives Priority Review for New Indication in Breast Cancer by China’s NMPA
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
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Lundbeck Secures Rights to Bexicaserin with Acquisition of Longboard Pharmaceuticals
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Lundbeck A/S (VIE: LUNA), a Danish pharmaceutical company, has announced its intention to acquire U.S.-based Longboard Pharmaceuticals, Inc. (NASDAQ: LBPH) in a deal valued at USD 60.00 per share in cash. The transaction, on a fully diluted basis, is worth USD 2.6 billion in equity terms and USD 2.5 billion…
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Stemirna Therapeutics, Once a Leading mRNA Developer in China, Enters Bankruptcy Proceedings
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Stemirna Therapeutics Co., Ltd, a one-time leading mRNA developer in China, has officially commenced bankruptcy proceedings, with the case accepted by the Pudong New Area People’s Court of Shanghai. Established in 2016, Stemirna secured a war chest exceeding RMB 1.5 million through a series of financing rounds from 2020 to…
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Novo Nordisk Expands Legal Campaign to 50 Cases Against Semaglutide Compounders
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Novo Nordisk (NYSE: NVO) has escalated its legal battles in the healthcare sector by filing a lawsuit against another semaglutide compounder, increasing the total number of such cases to 50. The Danish pharmaceutical giant, along with Eli Lilly (NYSE: LLY), has initiated legal campaigns targeting medical spas, weight loss clinics,…
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AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Sichuan Biokin Pharmaceutical Gets FDA Approval for CD33-Targeting ADC in Acute Myeloid Leukemia
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Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
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iRegene Therapeutics Secures Over USD 14 Million in Series B Financing to Advance Cell Therapies
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iRegene Therapeutics, a Wuhan-based biotechnology company specializing in the development of AI-enhanced chemically induced cell therapies, has announced the successful completion of its Series B financing round, raising over RMB 100 million (USD 14.15 million). The financing was co-led by Orinno Capital, with additional investments from Optics Valley Industrial Investment…
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BrightGene’s BGM0504 Shows Promise in Phase II Obesity Study Without Diabetes
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BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of…
