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Tianjin-Based Protein T Raises RMB 100 Million in Series A Financing
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Tianjin-based biotech Protein T, focused on multi-omics research, has reportedly raised close to RMB 100 million (USD 14.7 million) in a Series A financing round. The sole investor was Shanghai Dinghui Baifu Wealth Management. The proceeds will be used to facilitate Protein T’s business expansion, strategic layout, and the translation…
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Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its ASC10, an oral double prodrug antiviral, to evaluate its potential as a treatment for monkeypox. This approval marks a significant step in expanding the therapeutic applications of…
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Legend Biotech’s Carvykti Meets Primary Endpoint in CARTITUDE-4 Phase III Study
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Legend Biotech (NASDAQ: LEGN) has released positive data from the CARTITUDE-4 Phase III study, evaluating Carvykti (ciltacabtagene autoleucel; cilta-cel) as a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma (MM). The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard…
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CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 2.2 chemical octreotide long-acting injection in acromegaly. This marks a significant step forward in developing more convenient treatment options for patients with this rare…
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BeiGene’s Brukinsa Approved by FDA for Chronic Lymphocytic Leukemia
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In a separate announcement, BeiGene also noted that the Medicines…
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Dartsbio Pharmaceuticals Secures RMB 100 Million in Series B Financing
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Guangdong-based antibody drug developer Dartsbio Pharmaceuticals has reportedly raised over RMB 100 million in a Series B financing round. The round was led by Yuecai Holdings’ biomedicine fund, with participation from Fuho Capital, Qianhai Liyuan Fund Management, Ningbo Jingxing Zhiyuan Venture Capital, and Ningbo Jinghang Intelligent Inspection Venture Capital Fund.…
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CNBG-Virogin’s Omicron-Targeted mRNA Vaccine Approved for Clinical Trials
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CNBG-Virogin Biotech (Shanghai) Co., Ltd has announced obtaining clinical trial approval from the National Medical Products Administration (NMPA) for its Omicron variant-targeted mRNA vaccine. This marks a significant milestone in the development of COVID-19 vaccines tailored to emerging variants. Vaccine Development and InnovationThe product, China’s first COVID-19 mRNA vaccine encoding…
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Hepagene’s FXR Agonist HPG1860 Shows Positive Phase IIa Data in NASH Study
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China-based liver disease specialist Hepagene Therapeutics (HK) Limited has revealed positive data from the Phase IIa clinical study of its in-house developed FXR agonist HPG1860 in non-alcoholic steatohepatitis (NASH). The results highlight the drug’s potential in addressing this metabolic liver disease. Phase IIa RISE Study ResultsThe multi-center, randomized, double-blind, placebo-controlled…
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Ascentage Pharma Raises HKD 550 Million in Secondary Offering for Pipeline Expansion
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Suzhou-based Ascentage Pharma (HKG: 6855) is set to conduct a secondary offering of 22.5 million new shares to prominent investors, including JPMorgan Chase & Co., China International Capital Co., Ltd, and Citigroup Global Markets Asia Ltd. The offering is priced at HKD 24.45 (USD 3.12) per share, raising a total…
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BMS’s Opdivo Approved in China for Neoadjuvant Therapy in Urothelial Carcinoma
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US-based Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another new indication approval in China for its programmed death-1 (PD-1) inhibitor Opdivo (nivolumab). The immunotherapy is now approved for use as a neoadjuvant therapy for patients with urothelial carcinoma (UC) at high risk of recurrence after radical resection. This marks the…
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Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
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China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate a clinical study of its monoclonal antibody (mAb) HBM1007, a fully-human antibody targeting CD73. This marks a significant step forward in the development of innovative therapies targeting this key biomarker. HBM1007: Mechanism and DevelopmentHBM1007 is…
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Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
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China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai Livzon Monoclonal Antibodies Biotechnology Co. Ltd has received marketing approval in China for its biosimilar version of Roche Holding AG’s (OTCMKTS: RHHBY) Actemra/RoActemra (tocilizumab). This approval marks a significant milestone in expanding treatment options for…
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CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
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China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase II part of the ongoing CAN103 Phase I/II study. The trial is focused on treatment-naïve patients with Gaucher disease (GD) Types I and III in China. This milestone marks a significant step forward in the…
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GenScript ProBio Closes $220M Series C Financing for Biologics and Gene Therapy Expansion
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Contract Development and Manufacturing Organization (CDMO) GenScript ProBio has announced the completion of a $220 million Series C financing round led by Legend Capital. Other investors include Highlight Capital, C&D Emerging Industry Investment, New Alliance Capital, Service Trade Innovation Development Guidance Fund, Huatai Zijin Investment, Gf Xinde Investment, and Ciit…
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Roche and HKSTP Collaborate to Boost Life Sciences in Greater Bay Area
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Swiss pharmaceutical giant Roche (SWX: ROG) has signed a multi-faceted collaboration agreement with the Hong Kong Science and Technology Parks Corporation (HKSTP) to further the development of the life sciences industry in Hong Kong and the Greater Bay Area (GBA), which includes Macau and Guangdong Province. Key Areas of CollaborationThe…
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Burning Rock Upgrades 2022 Revenue Growth Forecast to 10% YOY
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Guangzhou-based medical device giant Burning Rock Ltd (NASDAQ: BNR) has issued a notice upgrading its guidance on expected revenue growth for 2022. The company now projects a 10% year-on-year (YOY) increase, up from the 5% announced in November last year. This upward revision is driven by a better-than-forecast performance in…
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Pasithea Therapeutics Partners with WuXi AppTec for API Manufacturing of PAS-004
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US-based Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced that Chinese Contract Research Organization (CRO) WuXi AppTec (SHA: 603259) will provide active pharmaceutical ingredient (API) manufacturing support for its lead candidate PAS-004 (formerly CIP-137401). Specifically, WuXi STA, a subsidiary of WuXi AppTec, will provide Good Manufacturing Practice (GMP) manufacturing to support…
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CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
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The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s rilonacept, and Zai Lab’s sulbactam/durlobactam (SUL-DUR) are set to obtain priority review statuses. These designations highlight the significance of these therapies in addressing critical medical needs. Vonicog Alfa: Vascular Hemophilia TreatmentVonicog alfa is a recombinant…
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Immunofoco’s CLDN18.2-Targeted CAR-T Therapy IMC002 Accepted for CDE Review
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China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an in-house developed CLDN18.2-targeted chimeric antigen receptor (CAR)-T therapy by Suzhou Immunofoco. This marks a significant milestone for the Chinese firm, which aims to develop the drug for treating advanced digestive system tumors with CLDN18.2 expression,…
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Keymed Biosciences’ CMG901 Shows Promising Results in Phase Ia Study for Solid Tumors
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China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase Ia dosage escalation study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of its CMG901. The study focuses on CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) for advanced solid tumors. The data…
