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RemeGen’s RC118 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based RemeGen Ltd announced that its antibody drug conjugate (ADC) drug candidate RC118 has obtained two orphan drug designations (ODD) from the US FDA, for the therapy’s potential use against gastric and pancreatic cancers. RC118: Mechanism and DevelopmentRC118, a novel ADC drug candidate co-developed with contract research organization (CRO) Biocytogen,…
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Innovent Biologics Presents Clinical Study Results at ESMO-IO 2022
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China-based Innovent Biologics Inc. (HKG: 1801) announced the presentation of two clinical studies at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO). IBI939 Phase Ib Study ResultsA Phase Ib study to evaluate the safety, tolerability, and efficacy of anti-TIGIT candidate IBI939 in combination with sintilimab in patients with…
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Science Standard Medical Testing Raises Pre-Series A Funding
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Science Standard Medical Testing, a professional third-party testing institution based in Changzhou, reportedly raised “tens of millions” of renminbi in a Pre-Series A financing round, a private funding backed by Suzhou Xilu Venture Capital Partnership Limited. Ascendin Fund supported the company’s previous angel financing. Company Background and ServicesFounded in 2015,…
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Phanes Therapeutics and BeiGene Partner on Phase I Study of PT199
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Sino-US biotech Phanes Therapeutics Inc. announced a clinical study cooperation and supply agreement with China-based biotech BeiGene (HKG: 6160, SHA: 688235, Nasdaq: BGNE) to carry out a Phase I clinical study assessing the safety and efficacy of Phanes’ PT199 combined with BeiGene’s tislelizumab in multiple advanced solid tumors. PT199: Mechanism…
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XtalPi Partners with CTTQ for AI-Driven Small-Molecule Drug Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. struck a partnership with China-based Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177). The two will work together on the development of small-molecule drugs in the liver disease field. No financial details were disclosed. AI…
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Harbour BioMed Concludes Phase I Study for HBM4003 in Advanced Melanoma
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Harbour BioMed (HBM; HKG: 2142), a biotech operating out of the United States, the Netherlands, and Suzhou (China), announced the conclusion of a Phase I clinical study for its anti-CTLA-4 antibody HBM4003 combined with Junshi Bio’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in advanced melanoma. The study has shown that…
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Frontier Biotechnologies Partners with Yuyue Med for FB2001 Atomizer
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China-based Frontier Biotechnologies Inc. (SHA: 688221) announced a strategic collaboration agreement with compatriot firm Jiangsu Yuyue Medical Equipment Inc. (SHE: 002223). Yuyue Med will supply Frontier Bio the atomizer of the designated model used in the early clinical trials of the FB2001 atomized inhalant bofutrelvir at a discounted price, alongside…
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Harbour BioMed’s Nona Biosciences Licenses Antibody Platform to Kelun-Biotech
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Harbour BioMed (HKG: 2142), a biotech operating out of the Netherlands, the United States, and China, announced that its wholly-owned subsidiary Nona Biosciences entered into a licensing agreement with China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Kelun-Biotech will obtain rights to utilize Nona Bio’s proprietary All H2L2 transgenic Harbour Mice platform…
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ExoNeuglia Secures Angel Funding for iPSC-Based Cell Therapy
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ExoNeuglia, a stem-cell-focused biotech based in Suzhou, reportedly raised “tens of millions” of renminbi in an angel financing round, solely backed by RedHill Capital. The company is self-described as the first domestic cell therapy company utilizing induced pluripotent stem cells (iPSCs) technology to treat demyelinating diseases. Demyelinating Diseases and Treatment…
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Jacobio’s KRAS G12C Inhibitor JAB-21822 Receives Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) website indicates that China-based Jacobio Pharmaceuticals Group Co., Ltd’s (HKG: 1167) KRAS G12C inhibitor JAB-21822 has received breakthrough therapy designation (BTD) status for its potential as a treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS p.G12C mutation. The…
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CSPC and Ascletis Get NMPA Approval for COVID-19 Drug Clinical Trials
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China-based firms CSPC Pharmaceutical Group Ltd (HKG: 1093) and Ascletis Pharma Inc. (HKG: 1672) both announced receiving the green light from the National Medical Products Administration (NMPA) to carry out clinical trials for their respective SYH2055 and ASC11, both inhibitor drugs targeting 3-chymotrypsin like protease (3CLpro) for COVID-19. Market Landscape…
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Yuanmai Cell Biotechnology Secures Angel Funding for Macrophage Immunotherapy
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Yuanmai Cell Biotechnology Co., Ltd, a macrophage immunotherapy developer based in Nanjing, reportedly raised “tens of millions” of renminbi in an angel financing round. CDH Investments and Renai Group led the funding, which included contributions from Nanjing Jiangbei New Area Sci-tech Investment Group and Nanjing Laoyan Venture Capital. Proceeds will…
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Yantai Dongcheng Pharma Acquires Rights to 18F-APN-1607 from Aprinoia Therapeutics
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced the plan to acquire the clinical trial approval and research and development (R&D) materials of 18F-APN-1607, a Tau protein positron photography tracer used for PET imaging diagnosis, from Japan’s Aprinoia Therapeutics Inc. and Aprinoia Therapeutics Suzhou, along with exclusive clinical…
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Shanghai Hantong Medtech Raises Angel Funding for Ultrasound Platform
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Shanghai Hantong Medical Technology Co., Ltd reportedly raised “tens of millions” of renminbi in an angel financing round led by Cowin Capital. Other investors included HiMed Angel Fund and Joyin Center. Proceeds will go towards interventional ultrasound platform construction, product research and development, and manufacturing. Company Focus and TechnologyHantong Medtech,…
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GenAssist Therapeutics Secures Series A Funding for Gene Therapy Development
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China’s Suzhou GenAssist Therapeutics Co., Ltd, a base editing technology-based gene therapy developer, reportedly raised “tens of millions” of US dollars in a Series A financing round. The medical business jointly set up by AstraZeneca and CICC Capital led the round, which included contributions from Baidu Venture, Sequoia Capital China,…
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Hansoh’s Generic Firazyr Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that China-based Hansoh Pharmaceutical Group Co., Ltd’s (HKG: 3692) generic version of Japan firm Takeda Pharmaceutical Co., Ltd’s Firazyr (icatibant) has been approved for marketing in China. Firazyr: Mechanism and Approval HistoryFirazyr, a selective bradykinin B2 receptor antagonist developed by Shire Pharmaceuticals,…
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NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
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The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi Lo (efavirenz, lamivudine, tenofovir) has been approved for marketing in China. The drug was awarded priority review status in May 2020 for use in human immunodeficiency virus type 1 (HIV-1) infection in adults and children…
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SciClone’s Danyelza Approved for Marketing in China by NMPA
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The National Medical Products Administration (NMPA) website indicates that SciClone Pharmaceuticals Inc’s (Nasdaq: SCLN) Danyelza (naxitamab) has been approved for marketing in China. Danyelza is a GD2-targeted monoclonal antibody originated by Y-mAbs Therapeutics Inc., and was fast-tracked for marketing approval in November 2020. SciClone struck a licensing deal with Y-mAbs…
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Enhertu Confirmed as New Standard of Care for Breast Cancer in Phase III Study
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AstraZeneca PLC (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) released the latest data supporting the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) as a new standard of care for breast cancer. An update from the DESTINY-Breast03 Phase III study assessing Enhertu head-to-head against Roche’s Kadcyla (trastuzumab emtansine, TDM-1) in patients with…
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Shaanxi Panlong Pharma Partners with Porton Pharma Solutions for Drug Development
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China-based Shaanxi Panlong Pharmaceutical Group Co., Ltd (SHE: 002864) announced a technology commission (development) agreement with compatriot firm Chongqing Porton Pharma Solutions, a contract development and manufacturing organization (CDMO) that will complete technical development, raw material research, process research, quality research, pharmacodynamics and toxicology research, clinical study, production, and regulatory…
