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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…
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Alphax Bio Raises Millions for Spatial Proteomics and Tumor Immune Microenvironment Research
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Beijing-based Alphax Bio, a developer of immune-testing technologies, has reportedly raised “tens of millions” of renminbi in a recent financing round, led solely by Cui Capital. The funds will be directed towards the clinical transformation of spatial proteomics tumor immune microenvironment assessment, the development of functional proteomics solutions, and the…
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Luye Pharma’s Lurbinectedin Gains Priority Review Status for SCLC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186) lurbinectedin (LY01017), an RNA polymerase II inhibitor, is set to obtain priority review status for the treatment of metastatic small cell lung cancer (SCLC) with tumor progression during or after platinum-based chemotherapy. Development and Mechanism…
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Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
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Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer…
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Sino Biopharmaceutical’s F-star Therapeutics Signs Second Licensing Deal with Takeda
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a second licensing agreement between its recently acquired subsidiary, F-star Therapeutics Inc. (NASDAQ: FSTX), and Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502). The deal provides Takeda with a next-generation tumor immunotherapy bispecific antibody (BsAb), with the specific target or other molecule details undisclosed.…
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AstraZeneca’s Calquence Receives Conditional Approval in China for MCL
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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Hinova Pharmaceuticals’ HC-1119 NDA Accepted for Review by NMPA
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Chengdu-based biotech Hinova Pharmaceuticals Inc. (SHA: 688302) has announced that the New Drug Application (NDA) filing for its Category 1 drug HC-1119 has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is for patients with metastatic castrate-resistant prostate cancer (mCRPC) who have failed to…
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Advenchen Lab’s AL8326 and Hengrui’s SHR-A1811 Receive Breakthrough Therapy Designations
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The Center for Drug Evaluation (CDE) website indicates that Advenchen Lab’s AL8326 and Hengrui Pharmaceuticals’ (SHA: 600276) SHR-A1811 have been awarded separate breakthrough therapy designations (BTDs). This recognition highlights the potential of both drugs to significantly improve the treatment of cancer patients. Advenchen’s AL8326: A Promising TKI InhibitorAdvenchen’s drug candidate…
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Biokin’s BL-B01D1 Receives NMPA Approval for Phase II Solid Tumor Study
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its drug candidate BL-B01D1 as a treatment for solid tumors. The study will evaluate the…
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Immunotech Biopharm’s CAR-T-19-D2 Receives NMPA Approval for DLBCL Clinical Trial
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) in recurrent/refractory diffuse large B-cell lymphoma (DLBCL). Mechanism of Action and Clinical NeedCAR-T-19-D2 targets the CD19…
