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CStone Pharmaceuticals’ Sugemalimab Study Published in JCO for R/R ENKTL Treatment
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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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IceCure Medical Gains NMPA Approval for Cryoablation Technology in China
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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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ImmVira’s MVR-C5252 Receives NMPA Approval for Glioma Treatment Development
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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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Transcenta’s Osemitamab Receives FDA Orphan Drug Designation for Pancreatic Cancer
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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 Achieves Full Enrollment in Phase II Study of IMM01 for CMML
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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’s OncoVent Secures Licensing Deal with Orient EuroPharma for Oregovomab
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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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Kintor Pharmaceutical Realigns Funds from COVID-19 Studies to Other Pipeline Candidates
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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’ SPH4336 Earns Orphan Drug Status for Liposarcoma Treatment
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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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Junshi Biosciences and Rxilient Biotech Form JV to Commercialize Tuoyi in Southeast Asia
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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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CDE Grants Priority Review Status to TQB3454, HLX208, and Infigratinib for Cancer Treatments
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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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Berry Genomics Partners with MGI Tech to Advance Cancer Diagnostics and Screening
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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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BJ Bioscience Partners with MSD for Phase I Clinical Trial of BJ-001 and Keytruda
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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…
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CANbridge Pharmaceuticals Completes Enrollment in Phase II GBM Trial for CAN008
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Sino-US biopharma CANbridge Pharmaceuticals (HKG: 1228) has announced the completion of patient enrollment in a Phase II trial for its pipeline candidate CAN008 (asunercept) in combination with temozolomide for the treatment of glioblastoma multiforme (GBM). The multi-center, randomized, placebo-controlled study, which is potentially registrational, has recruited a total of 117…
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CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Development
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The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on “Clinical R&D of Anti-tumor Drugs for Children,” which are now in immediate effect. These guidelines were drafted in response to the need for more targeted research and development efforts for pediatric anti-tumor drugs, an area…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Gain Clinical Trial Approvals
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Akeso Biopharma and LaNova Medicines Collaborate on Clinical Studies for Cancer Therapies
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China-based Akeso Biopharma (HKG: 9926) has announced a strategic partnership with fellow Chinese firm LaNova Medicines to advance a series of clinical studies. The collaboration will assess a combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), with LaNova’s LM-302,…
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Sihuan Pharmaceutical’s XZP-KM602 and XZP-6877 Secure Clinical Trial Approvals for Solid Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that its minority-owned subsidiary, Xuanzhu Biopharmaceutical Co., Ltd, has obtained clinical trial approvals for two in-house developed drugs: CD80 mutant Fc fusion protein XZP-KM602 and DNA dependent protein kinase (DNA-PK) inhibitor XZP-6877. Both drugs are aimed at treating advanced solid…
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Akeso Biopharma and LaNova Medicines Collaborate on AK112 and LM-302 Combo for Solid Tumors
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China-based Akeso Biopharma (HKG: 9926) has entered into a strategic partnership with compatriot firm LaNova Medicines to advance a series of clinical studies. These studies will assess the combination regimen of Akeso’s AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF), alongside LaNova’s LM-302,…
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CDE Launches Technical Guidelines for Pediatric Anti-tumor Drug Clinical R&D
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The Center for Drug Evaluation (CDE) has released a set of Technical Guidelines focused on “Clinical R&D of Anti-tumor Drugs for Children,” which are now in immediate effect. These guidelines were drafted to address the specific needs and considerations in the development of anti-tumor drugs for pediatric patients. Public Consultation…
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Sihuan Pharmaceutical’s KM501 Receives Clinical Trial Approval for HER2-Positive Tumors
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China-based Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its XZP-KM501 (KM501) in solid tumors with HER2 positive, middle to low-expression. This marks a significant step forward in the development of innovative treatments for…
