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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…
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3SBio Inc. Reports 7.5% Revenue Growth in 2022 Financials
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China-based 3SBio Inc. (HKG: 1530) released its 2022 financial report, recording revenues of RMB 6.859 billion (USD 995.9 million), a 7.5% increase year-on-year (YOY). Net profits reached RMB 2.163 billion (USD 314 million), up 25.2% YOY. This marks a significant milestone in the company’s ongoing growth and expansion. Core Product…
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Jacobio Pharma Partners with Merck to Evaluate CD73 mAb and Keytruda Combination
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China-based Jacobio Pharma (HKG: 1167) has announced a clinical partnership with Merck, Sharp & Dohme Inc. (NYSE: MRK) to assess the clinical effects of Jacobio’s CD73 monoclonal antibody (mAb) JAB-BX102 combined with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in advanced solid tumors. No financial details were disclosed in the partnership agreement.…
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BioNTech Acquires Global Rights to OncoC4’s Anti-CTLA-4 Antibody ONC-392
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Germany-based mRNA specialist BioNTech SE (NASDAQ: BNTX) has unveiled a licensing deal and collaboration with US-based biotech OncoC4, securing global development and commercialization rights to OncoC4’s anti-CTLA-4 antibody ONC-392. Under the terms of the agreement, BioNTech will pay OncoC4 USD 200 million upfront, with further undisclosed development and commercial milestone…
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L&L Biopharma Completes Series B Financing for Tumor Immunotherapy Development
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Shanghai-based tumor immunotherapy developer L&L Biopharma Co., Ltd has announced the completion of a Series B financing round, led by Hongfeng Venture. Additional investors included Oriental Wisdom Capital, Zhongchuang Yongjian (Ningbo) Venture Capital, and existing investor Qiao Jing Capital. The funds will be directed towards Phase I clinical studies for…
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Yiling Pharmaceutical’s BIO-008 Receives NMPA Approval for Clinical Trials
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel biologic product BIO-008. This marks a significant milestone in the development of the company’s innovative therapeutic biologic. Development and IndicationsBIO-008 is a monoclonal antibody…
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Bayer’s Nubeqa Receives Additional NMPA Approval for mHSPC Treatment-Fineline Info & Tech
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German pharmaceutical giant Bayer AG (ETR: BAYN) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its drug Nubeqa (darolutamide). The drug, which was previously approved for use in non-metastatic castration-resistant prostate cancer (nmCRPC) in February 2021, can now be used to…
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Janssen Withdraws Carvykti from UK Market Amid Manufacturing Concerns
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US-based Janssen Pharmaceutical reportedly decided to withdraw Carvykti (ciltacabtagene autoleucel; cilta-cel) from the UK market last week. The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, which is under development globally by Janssen in partnership with China-based Legend Biotech (NASDAQ: LEGN), was being assessed by the UK’s National Institute of…
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BeiGene Declines Option for Leap Therapeutics’ DKN-01 Development Rights in Asia
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US-based Leap Therapeutics Inc. (NASDAQ: LPTX) announced last week that China-based BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) had declined to exercise its option to take up development and commercial rights in Asia for DKN-01, Leap’s anti-Dickkopf-1 (DKK1) monoclonal antibody (mAb). Despite this decision, the two companies will continue…
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Jacobio Pharma’s JAB-24114 Receives CDE Approval for Phase I/IIa Clinical Study
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/IIa clinical study for its in-house developed JAB-24114, a glutaminase enzyme (GUE) inhibitor. This marks a significant step forward in the development of innovative cancer therapies. Mechanism…
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Tot Biopharmaceutical Terminates Phase III Study for HER2-Targeted ADC TAA013
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Tot Biopharmaceutical International Co., Ltd (HKG: 1875) has announced the termination of the Phase III clinical study for its HER2-targeted antibody-drug conjugate (ADC) TAA013. The decision was made due to significant changes in the market competitive landscape for the drug target and technology. Rational Resource Allocation and Strategic TransformationThe China-based…
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Shouyao Holdings Receives CDE Approval for Phase II Study of Third-Generation ALK Inhibitor
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) to conduct a single-arm pivotal Phase II clinical study. The study will focus on patients with ALK gene fusion-positive advanced non-small cell lung cancer (NSCLC) who…
