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Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
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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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Innovec Biotherapeutics’ IVB103 Gene Therapy for nAMD Receives Clinical Trial Approval from China’s CDE
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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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Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
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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’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
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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 Gets NMPA Green Light for HP568 Clinical Study in Breast Cancer
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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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Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
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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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Leqembi, Alzheimer’s Drug by Eisai and Biogen, Now Covered by Qihuibao Insurance in China
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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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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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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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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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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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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…
