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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…
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Likang Life Sciences’ Personalized Neoantigen Vaccine LK101 Receives IND Approval
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Likang Life Sciences has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its LK101, a personalized neoantigen-targeted vaccine. This marks the first personalized neoantigen vaccine and mRNA editing product to be approved for clinical trials by the NMPA. LK101 will…
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RemeGen Gains NMPA Approval for Phase I/IIa Study of RC88 with Junshi Bio’s PD-1 Inhibitor
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China-based pharmaceutical firm RemeGen (HKG: 9995) has received approval from the National Medical Products Administration (NMPA) to conduct an open, multi-center Phase I/IIa study. The study will assess the safety, tolerability, pharmacokinetics, and efficacy of RC88 combined with Junshi Bio’s (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab),…
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ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment…
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Henlius’ OX40 Monoclonal Antibody HLX51 Gains NMPA Approval for Phase I Clinical Study
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Shanghai Henlius Biotech, Inc (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study in mainland China for its OX40 monoclonal antibody (mAb), HLX51. The study will focus on patients with advanced/metastatic solid tumors and lymphoma. Mechanism…
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Haisco Pharmaceutical’s EGFR-PROTAC HSK40118 Gains NMPA Approval for Clinical Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral small molecule EGFR-PROTAC, HSK40118. The drug is targeted for the treatment of advanced non-small cell lung cancer (NSCLC). Drug Mechanism and Pre-Clinical ResultsHSK40118…
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Astellas Pharma’s Xtandi Gains Momentum in China with Positive Phase III ARCHES Study Results
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that its prostate cancer therapy, Xtandi (enzalutamide), is poised to add a new indication for the China market following positive results from the Phase III China ARCHES study. The trial evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with…
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MabPharm Files NDA for CMAB009, Biosimilar to Erbitux, Targeting Metastatic Colorectal Cancer
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Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the filing of a New Drug Application (NDA) for its CMAB009, a biosimilar of Merck KGaA (ETR: MRK)/Bristol-Myers Squibb’s (BMS, NYSE: BMY) cetuximab (trade name: Erbitux). The filing has been accepted for review by the National Medical Products…
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Neowise Biotechnology Secures RMB 200 Million in Series A+ Financing Round
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Neowise Biotechnology Co., Ltd, a T cell receptor (TCR)-therapy developer based in Suzhou, reportedly raised close to RMB 200 million (USD 29 million) in a Series A+ financing round. This investment will support the company’s ongoing research and development efforts in TCR therapies. Investor ParticipationThe financing round was led by…
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Immorna Enrolls First Patient in Phase I Study of JCXH-211 for Malignant Tumors
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Immorna (Hangzhou) Biotechnology, an mRNA-based vaccine developer based in Hangzhou, has announced the enrollment of the first patient in a Phase I clinical study to assess the safety and efficacy of JCXH-211, a potential cancer therapeutic, in malignant solid tumors in China. The study will determine the recommended Phase II…
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CDE Issues Guidelines on Single-Arm Clinical Trials for Antitumor Drugs
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for the Applicability of Single-arm Clinical Trials to Support the Market Filing for Antitumor Drugs.” The document provides clarity on the limitations of single-arm clinical trials, their applicability, and the requirements for confirmatory clinical trials in support of both…
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Laekna Therapeutics Files for IPO on Hong Kong Stock Exchange, Aims to Expand Cancer and Hepatic Fibrosis Therapies
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China’s Laekna Therapeutics Shanghai Co., Ltd has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange (HKSE), according to the exchange. The offering will be sponsored by CICC. This move marks a significant step in Laekna’s growth strategy as it seeks to raise capital to further…
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Juventas Cell Therapy’s CNCT19 Receives FDA IND Approval for r/r B-ALL Treatment
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China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL). Previous Approvals and StatusCNCT19, a CD19-targeted CAR-T therapy, has previously earned IND…
