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Simcere Receives NMPA Clearance for SIM0348 Clinical Study
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced receiving clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its SIM0348, a bispecific antibody (BsAb) targeting TIGIT and PVRIG in advanced malignant solid tumors. Mechanism of Action and DesignSIM0348 is designed to block the interaction between…
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Hainan Shuangcheng Files Paragraph IV Patent Declaration for Paclitaxel, Albumin-Bound
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China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) has announced a Paragraph IV patent declaration in relation to the Abbreviated New Drug Application (ANDA) for its Paclitaxel, albumin-bound. This declaration indicates that Shuangcheng believes its drug does not infringe on the rights of Bristol-Myers Squibb’s (BMS, NYSE: BMY) originator drug…
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Immunotech Biopharm’s CAR-T-19-D2 IND Filing Accepted by NMPA
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China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that an Investigational New Drug (IND) filing for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is recurrent and refractory diffuse large B-cell lymphoma…
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Guangzhou Mygene Raises ‘Hundreds of Millions’ in Series C Financing Led by Efund Capital
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China-based molecular diagnostic product developer Guangzhou Mygene Medical Technology Co., Ltd reportedly raised “hundreds of millions” of renminbi in a Series C financing round led by Efund Capital. Other investors included Anggu Fuge Investment, Juyo Capital, Benchi Capital, and Hongtu Runda Capital. The proceeds will be used for research and…
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Carrier Biomed Raises ‘Tens of Millions’ in Series A+ Financing Round
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Carrier Biomed (Soohow) Co., Ltd, an exosome technology developer based in Suzhou, has reportedly raised “tens of millions” of renminbi in a Series A+ financing round. The funding was led by existing investors Qingnuo Capital and Tianjin Qingzhi Technology Partnership, along with Suzhou Industrial Park Science and Technology Innovation Investment…
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InnoCare Pharma Receives Hong Kong Approval for Tafasitamab in DLBCL
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China-based biopharma InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving market approval from the Department of Health in Hong Kong for its tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).…
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CStone Pharmaceuticals Publishes Ayvakit Study Results on Oncologist Website
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China-based CStone Pharmaceuticals (HKG: 2616) has published the results of the China-based bridging NAVIGATOR study for its Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST), on the Oncologist website. The open-label, multi-center Phase I/II study was designed to assess the safety, pharmacokinetics, and anti-tumor efficacy…
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Biosion Completes Series B Financing Round Led by Guangfa Xinde Investment
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Biosion, a global, clinical-stage biotech committed to developing antibody-based therapies targeting immune and oncologic diseases, has announced the completion of a Series B financing round at upwards of RMB 100 million (USD 14.33 million). The funding was led by Guangfa Xinde Investment, with contributions from FangFund, Addor Capital, and Suxin…
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Ablaze Pharma and Yonghe Partner for Targeted Radiotherapy Development
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China-based Ablaze Pharma and Yonghe Pharmaceutical have struck a partnership agreement for the research and development (R&D) and commissioned manufacturing of targeted radiotherapy (TRT). Yonghe, Ablaze’s Contract Development and Manufacturing Organization (CDMO) partner, will provide R&D and cGMP-compliant manufacturing services from the pre-clinical to clinical stages. Company Background and Partnership…
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Innovent Biologics’ GFH925 Receives Breakthrough Therapy Designation
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China’s Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics (HKG: 1801) has received a breakthrough therapy designation (BTD) for its Category 1 chemical drug GFH925. The drug is intended for the treatment of KRASG12C mutant advanced non-small cell lung cancer (NSCLC) in patients who have previously received…
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Junshi Biosciences’ PD-1 Inhibitor Tuoyi Faces FDA Review Delay
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Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that they have not received an action letter from the US FDA regarding the Biologics License Application (BLA) for the programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab). The ongoing delay is attributed to the failure to inspect the manufacturing site. The…
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Antengene and MSD Collaborate on Global Clinical Study for ATG-037
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China-based Antengene Corporation Limited (HKG: 6996) has announced a global clinical collaboration with Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) to conduct a multicenter, open-label, Phase I dose-finding study for ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab). The targeted indication is locally advanced…
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IASO Biotherapeutics Receives FDA Approval for CT103A IND Application
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China-based IASO Biotherapeutics has announced approval from the US FDA for an Investigational New Drug (IND) application for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy CT103A (equecabtagene autoleucel). The therapy will be assessed in US-based clinical trials for relapsed/refractory multiple myeloma (r/r MM). Drug Profile and DevelopmentEquecabtagene autoleucel…
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CSPC’s NBL-020 Receives FDA IND Approval for Advanced Solid Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving Investigational New Drug (IND) approval from the US FDA for its antibody-drug NBL-020. The targeted indication is advanced solid tumors, marking a significant step forward in the development of this innovative therapy. Drug Profile and Mechanism of ActionNBL-020 is an…
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Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval
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Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.…
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Jing Medicine’s HJM-353 Gains Clinical Trial Approvals in US and China
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China-based Jing Medicine Technology (Shanghai) Co., Ltd’s HJM-353 has obtained clinical trial approvals in the US and China. The investigational embryonic ectoderm development (EED) inhibitor is expected to enter a Phase I clinical study for advanced blood cancer and solid tumors. Mechanism of Action and DevelopmentPolycomb repressive complex 2 (PRC2)…
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Junshi Biosciences Licenses PD-1 Inhibitor Tuoyi to Hikma MENA FZE
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced a licensing agreement with UK-headquartered Hikma MENA FZE, granting the latter exclusive development and commercialization rights to its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in Jordan, Saudi Arabia, the United Arab Emirates, Qatar, Morocco, and Egypt, among a total of 20…
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MSD and Kelun Biotech Ink Record-Breaking ADC Deal
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Merck, Sharp & Dohme (MSD, NYSE: MRK) has set a new benchmark for the largest out-licensing deal between a multinational and a China-based firm. The US giant has returned to sign its third deal of this year with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, securing development, manufacturing, and commercialization rights to…
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Shyndec’s Generic Cytosar-U Gains Marketing Approval in China
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China-based Shanghai Shyndec Pharmaceutical Co., Ltd (SHA: 600420) has announced that its generic version of Pfizer’s (NYSE: PFE) Cytosar-U (cytarabine) has obtained marketing approval in China. This marks the first generic to pass the generic quality consistency evaluation among similar products in the country. Product Profile and Market ContextCytarabine for…
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Antengene Files for Xpovio Approval in Macau, Malaysia, and Thailand
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Antengene Corp., Ltd (HKG: 6996) has announced market filings for its Xpovio (selinexor) in Macau, Malaysia, and Thailand, with indications for relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The China-based biopharma also plans to make another market filing in Indonesia…
