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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I/IIa study for its drug candidate HDM2027 (HDP-101). This antibody drug conjugate (ADC), co-developed with Heidelberg Pharma, targets the B cell maturation…
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions in China, has announced that it has received marketing approval from the National Medical Products Administration for its innovative product, NeoGlu 01, a noninvasive blood glucose meter. This new device combines optical and thermal methods…
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Leqembi (lecanemab), an Alzheimer’s disease treatment co-developed by Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB), has been included in the coverage scope of “Qihuibao,” a commercial supplementary health insurance program in Zibo city, Shandong province, China. The drug received approval in China in January of this year…
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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 (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 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 & 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 (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 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 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 (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 (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 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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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 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 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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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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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 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, 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…