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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has announced a new attempt at a market filing with the US Food and Drug Administration (FDA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, in combination with the small-molecule targeted cancer therapy apatinib, as…
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Beijing InnoVec Biotherapeutics Inc., a leading gene therapy company based in China, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its IVB103 treatment for neovascular (wet) age-related macular degeneration (nAMD). This follows a clinical trial approval for the same indication in…
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CORXEL, formerly known as Ji Xing Pharmaceuticals and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved a significant milestone with the acceptance of their market filing for aficamten by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. Aficamten, a next-generation cardiac myosin inhibitor, is…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its drug candidate, hetrombopag olamine. This new indication is for the use of hetrombopag olamine in combination with…
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech firm based in Chengdu, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its drug candidate HP568. This new drug is intended for the treatment of estrogen receptor (ER) positive, human epidermal…
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Boehringer Ingelheim (BI), a leading German pharmaceutical company, has announced a research collaboration and license agreement with Circle Pharma, a US-based firm. This strategic partnership aims to develop a first-in-class cyclin inhibitor, a novel approach that could halt the growth of cancer cells and offer new hope for patients struggling…
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TenNor Therapeutics, a clinical-stage pharmaceutical company based in China, has announced the successful completion of its Series E financing round, raising RMB 300 million (USD 42.16 million). The financing was co-led by Zhongshan Venture Capital and the AMR Action Fund. The funds raised will be directed towards the late-stage clinical…
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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…