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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…
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore has accepted for review the New Drug Application (NDA) for its Nefecon (targeted-release formulation-budesonide) for adult patients with IgA nephropathy at risk of disease progression. The drug is anticipated to receive approval within the year.…
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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US-based OncoSec Medical Inc., (OTCMKTS: ONCSQ), majority-owned by China-based Grand Pharmaceutical Group Ltd (HKG: 0512), has revealed disappointing data from a crucial pivotal Phase II trial assessing the firm’s lead DNA drug candidate TAVO-EP (tavokinogene telseplasmid) combined with the programmed death-1 (PD-1) monoclonal antibody Keytruda (pembrolizumab) as a treatment for…
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China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to conduct a Phase I/IIa clinical study for its leukemia inhibitory factor (LIF) monoclonal antibody (mAb) in patients with advanced solid tumors. LIF as a Target for KRAS-driven TumorsLIF is a key target in KRAS-driven tumors, including pancreatic and…