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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study assessing the safety, pharmacokinetics, and preliminary efficacy of its antibody-drug conjugate (ADC) CPO301 in patients with advanced lung cancer characterized by…
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline drug candidate, FCN-338. The study will assess the efficacy of FCN-338 in treating malignant hematological diseases of the…
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China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and/or azacitidine,…
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has announced the publication of efficacy study results for its Category 1 chemical drug, KC1036, in the treatment of advanced esophageal squamous cell carcinoma (ESCC). The drug was evaluated as a second-line therapy for patients who have already failed previous standard treatments. Study…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its next-generation FGFR4 mutant inhibitor, ABSK012, intended for the treatment of soft-tissue sarcoma. Preclinical Efficacy of ABSK012 Against FGFR4 MutantsPreclinical studies have…
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Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor of VEGFR-1, -2, and -3, fruquintinib. The drug is proposed for the treatment of refractory metastatic…
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Ablaze Pharma, a Chinese biopharmaceutical company, has announced its development plan for a GPC3-targeted polypeptide drug candidate, as part of an ongoing licensing deal with US-based RayzeBio. The agreement aims to develop and commercialize the product in Greater China, expanding Ablaze’s portfolio and strengthening its commitment to cancer therapies. Licensing…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a prominent Chinese pharmaceutical company, has announced the start of a Phase III clinical study in the Chinese mainland for its HER2-targeted antibody drug conjugate (ADC), FS-1502. The study is focused on the treatment of HER2-positive unresectable, locally advanced, or…
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, announced that the Journal of Clinical Oncology (JCO) has published the results of the registrational clinical study GEMSTONE-201 for the PD-L1 antibody sugemalimab in the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). This study represents the largest registrational clinical…
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Israel-based IceCure Medical (NASDAQ: ICCM) has announced that it has obtained regulatory approval from China’s National Medical Product Administration (NMPA) for the commercial launch of its IceSense3 disposable cryoprobes product and its accompanying product console. This minimally-invasive cryoablation technology utilizes liquid nitrogen to freeze and destroy tumors, offering a treatment…
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China-based biotechnology company ImmVira has received approval from the National Medical Products Administration (NMPA) for its potentially groundbreaking oncolytic virus product, MVR-C5252, which is under development to treat gliomas. This first-in-class product marks a significant step forward in the treatment of brain tumors. Global Context and PrecedenceIn June 2021, Japanese…
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China-based biotechnology company Transcenta Holdings Ltd (HKG: 6628) has announced that its drug TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin 18.2 monoclonal antibody (mAb), has received orphan drug designation (ODD) status from the US FDA for the treatment of pancreatic cancer. This follows a previous ODD granted in 2021 for the…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced the successful completion of patient enrollment in its Phase II clinical study (IMM01-02), which investigates the combination of IMM01 with azacitidine for the treatment of naïve chronic myelomonocytic leukemia (CMML). The study has fully enrolled 20 patients, marking a significant milestone in the…
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399) has announced that its subsidiary, OncoVent, has entered into a licensing agreement with Taiwan-based Orient EuroPharma Co., Ltd for the immunotherapy drug oregovomab. The agreement grants Orient exclusive commercialization rights to oregovomab in Taiwan, with additional preemptive rights for exclusive sales, marketing,…
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced a strategic change in the allocation of proceeds from previous subscriptions. The company has decided to redirect HKD 509 million (USD 64.8 million), initially intended for the clinical development and commercialization of proxalutamide, pyrilutamide, and AR-PROTAC GT20029, away from clinical studies for…
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Shanghai Pharmaceuticals, a leading pharmaceutical company based in China (HKG: 2607, SHA: 601607), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its drug candidate, SPH4336. This designation is for the potential treatment of liposarcoma, a rare form of cancer.…
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China-based biopharmaceutical company Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a joint venture (JV) with Taiwan-headquartered Rxilient Biotech to develop and commercialize its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), across Southeast Asia. The agreement covers key territories including Thailand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, and Vietnam.…
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The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQB3454, Henlius Bio’s HLX208, and LianBio’s infigratinib are all set to be awarded priority review status as Category 1 chemical drugs. TQB3454: A Promising IDH1 Mutase InhibitorTQB3454 is an in-house developed IDH1 mutase inhibitor intended for the…
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Chengdu-based Berry Genomics Co., Ltd has announced a strategic partnership with MGI Tech, a subsidiary of BGI Group (SHE: 300676), based in China. The collaboration aims to localize and transform comprehensive cancer care by introducing automation platforms for sequencing pipelines across the entire cycle of precise diagnosis and treatment of…
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Shanghai-based biotech BJ Bioscience Inc. has announced a clinical trial collaboration and supply agreement with Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK). This strategic partnership will see the combination of BJ Bio’s pipeline candidate, BJ-001, with MSD’s programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), in a Phase I clinical trial…