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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed daxibotulinumtoxin A for injection (RT002). The drug is intended for use in the temporary improvement of moderate to severe frown lines in adults, attributed…
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has declared that the Phase III FLAMES study for senaparib (JS109/IMP4297), a PARP inhibitor co-developed with Impact Therapeutics Inc., has achieved the pre-set optimal efficiency threshold, marking the trial’s primary endpoint. The study targets the first-line maintenance treatment for stage III/IV ovarian cancer,…
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China-based Luye Pharma Group (HKG: 2186) has announced that the market approval filing for its biosimilar version of Roche’s Avastin (bevacizumab) has been accepted for review by Brazil’s National Health Surveillance Agency (ANVISA). Luye’s Biosimilar Approval and Global OutlookLuye’s biosimilar bevacizumab was approved in China in 2021 to treat indications…
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Global pharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced the market launch in China of Zeposia (ozanimod), the world’s first selective sphingosine-1-phosphate (S1P) receptor modulator indicated for the treatment of recurrent multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. Mode…
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
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China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its product Carteyva (relmacabtagene autoleucel injection; relma-cel). The treatment will be assessed for its efficacy in managing moderate-to-severe refractory systemic lupus erythematosus (SLE). Understanding Systemic Lupus Erythematosus (SLE)SLE is a…
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The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig (ponatinib) is on track to obtain priority review status for the treatment of specific leukemia conditions in China. These include chronic myeloid leukemia (CML) that is resistant or intolerant to previous medications, recurrent or refractory…
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According to an analysis, the US FDA issued complete response letters (CRLs) to six novel drugs seeking first approval approvals during the first quarter of 2023. These CRLs highlight the stringent requirements for efficacy and safety data that the FDA demands before granting market access to new pharmaceuticals. Eli Lilly’s…
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication). XY0206: A Promising Multi-Target Tyrosine Kinase InhibitorXY0206…
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its novel anti-microbial agent MRX-4, used in combination with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in China. Global Multi-Center Phase III Study Design and ApprovalThe global multi-center, randomized, double-blind Phase…
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China-based TYK Medicines, Inc. has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed next-generation tyrosine kinase inhibitor (TKI). This marks a significant step forward in the development of the company’s pipeline, with a separate clinical trial filing for…
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-licensed Category 5.1 drug Hyruan ONE (sodium hyaluronate), which is indicated for use in knee osteoarthritis. Hyruan ONE: A Single-Dose Preparation for Knee OsteoarthritisHyruan ONE, originally developed by LG…
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving the green light from the regulatory body in Singapore to initiate a Phase I clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets fibroblast activation protein (FAP) and is under development to treat FAP-positive advanced solid tumors. This…
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product. The therapy is set to be assessed as a treatment for idiopathic…
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug, HSK38008 oral preparation, in the treatment of prostate cancer. HSK38008: An Androgen Mutant AR-V7 Oral Degradation AgentHSK38008 is an androgen mutant…
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a single-center, randomized, double-blind, placebo-controlled, dosage escalation Phase Ia study. The study will assess the safety, tolerability, and pharmacokinetics of G201-Na in healthy adult males in China. G201-Na: A Small…
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced preliminary clinical data for its antibody-drug conjugate (ADC) 9MW2821, which targets Nectin-4. The data demonstrated positive therapeutic signals in multiple solid tumors and exhibited a good safety profile at the recommended Phase II dosage (RP2D). Mechanism of Action and Pharmaceutical…
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AffaMed Digital, a company wholly owned by AffaMed Technologies—a joint venture between AffaMed Therapeutics and SIFI S.p.A.—has announced the first patient enrollment in a clinical study for its AMD201 at the Beijing Tiantan Hospital. This marks a significant step in the development of digital therapies for post-stroke cognitive impairment (PSCI).…
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Shanghai-based Corxel Pharmaceuticals (CORXEL), supported by RTW Investments, has announced that its OC-01 (varenicline) nasal spray has been approved by the Hainan Medical Products Administration as a clinically urgently needed import drug in Bo’ao Super Hospital. This marks a significant milestone as the product is the world’s first and only…