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Shanghai Pharmaceuticals Concludes Phase II Study for I037 in Acute Ischemic Stroke
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Shanghai Pharmaceuticals Holding Co., Ltd. (HKG: 2607, SHA: 601607) has announced the completion of data analysis from the Phase II study for its drug candidate I037, used in the treatment of acute ischemic stroke (AIS). LT3001 is recognized as a first-in-class AIS therapy that combines targeted thrombolysis with neuroprotective functions…
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Henlius Biotech Initiates US Commercial Supply of Hanquyou, Biosimilar to Herceptin
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the initiation of commercial supply of its biosimilar product, Hanquyou (trastuzumab; HLX02), in the US market. This move marks the expansion of the company’s commercial supply network to include China, South Asia, North America, Europe, the Middle East, and Latin America. Herceptin…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for Lupus Nephritis Phase II Study
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for its dual-target macromolecular drug, amulirafusp alfa (IMM0306), in lupus nephritis (LN). Dual-Targeting Therapy with IMM0306IMM0306 is a bispecific antibody (BsAb) that targets…
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Healthgen Biotechnology’s Plant-Made Albumin Breakthrough: A Milestone in Serum Therapy
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On November 30th, Healthgen Biotechnology Corp. announced a significant research outcome at the 9th Pharmaceutical Innovation and Investment Conference. The company’s independently developed recombinant human serum albumin injection (Aofumin®) has successfully met its clinical study endpoints, marking a notable advancement in the field of plant-based recombinant protein drugs globally. Clinical…
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XellSmart Bio-Pharmaceutical Achieves Milestone with First Patient Enrollment in Global iPSC Clinical Study for ALS
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XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd., in collaboration with Shanghai East Hospital (Tongji University Affiliated East Hospital) and Liu Zhongmin’s team, has successfully enrolled the first patient in the global clinical study for “Clinical Grade iPSC-Derived Subtype Neural Progenitor Cell Therapy for Amyotrophic Lateral Sclerosis (ALS).” This marks a significant milestone…
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Cutia Therapeutic’s CU-20401 Shows Positive Results in Phase II Subcutaneous Fat Reduction Study
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China-based dermatology specialist Cutia Therapeutic (HKG: 2487) has revealed a positive readout from its Phase II study for the potential Category 1 drug CU-20401, a recombinant mutant collagenase, in the treatment of subcutaneous fat accumulation, meeting its primary endpoint. Efficacy and Safety Profiles of CU-20401The treatment efficacy rates of both…
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CDE Expands Care Plan with Approvals for Ractigen’s RAG-17 and Vitalgen’s VGR-R01
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In a swift succession of actions, China’s Center for Drug Evaluation (CDE) has added two more rare disease drugs to its patient-centered rare disease drug development pilot program, known as the Care Plan. This follows three other approvals within a 10-day period. The latest inclusions are Ractigen Therapeutics’ RAG-17 and…
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Jiangsu Kanion Pharmaceutical Gets NMPA Clearance for Oncolytic Virus Product KYS202003A
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational product, KYS202003A. The Chinese company is set to initiate a clinical study assessing this Category 1 biologic product for the treatment of advanced solid tumors.…
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Sichuan Biokin Pharmaceutical’s BL-M08D1 ADC Receives NMPA Approval for Clinical Trials
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
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Laekna, Inc. Initiates IND-Enabling Study for Monoclonal Antibody LAE123 in Severe Diseases
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe…
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Eisai and Biogen Launch Alzheimer’s Treatment Leqembi in South Korea
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the commercial launch of their co-developed amyloid-beta (Aβ) monoclonal antibody, Leqembi (lecanemab), in South Korea. The Ministry of Food and Drug Safety (MFDS) had previously approved the drug in May 2024 for the treatment of adult…
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Huadong Medicine’s Arcalyst Receives NMPA Approval for Cryopyrin-Associated Periodic Syndromes
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
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Huadong Medicine’s Elahere (Mirvetuximab Soravtansine) Approved by NMPA for Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have…
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MicuRx Pharmaceuticals’ MRX-4 Combo Shows Positive Results in Phase III Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced positive results from a Phase III study for its drug MRX-4 in combination with contezolid as sequential therapy for complex skin and soft tissue infections. The study successfully met its primary efficacy endpoint, demonstrating good clinical and microbiological efficacy. The regimen’s…
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Jiangsu Kanion Pharmaceutical Secures NMPA Approvals for KYHY2302 and KYHY2303
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
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BeiGene’s Tevimbra Receives EC Approval for First-Line ESCC and G/GEJ Adenocarcinoma Treatments
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China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC)…
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Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Cervical Muscle Tone Disorders
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has approved another indication for its product Daxxify (daxibotulinumtoxin, RT002). The type A botulinum toxin is now approved for the treatment of adult cervical muscle tone disorders in China. Background on…
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Phil Rivers Technology Secures IND Approval for PR00012 from NMPA’s CDE
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Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
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Hansoh Pharmaceutical’s Ameile Receives NMPA Review for Fifth Indication in NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic…
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China Medical System Holdings Gets NMPA Approval to Test Obesity Treatment CMS-D005
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China Medical System Holdings Ltd (CMS, HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study in China. The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of CMS-D005 in healthy and overweight and obese adult subjects. Dual…
