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Junshi Biosciences’ TAB009/JS009 and JS110 Advance in Cancer Trials
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Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, as a monotherapy for advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110…
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Junshi Biosciences Gets NMPA Go-Ahead for TAB009/JS009 Cancer Study
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Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for its injectable monoclonal antibody TAB009/JS009, targeting CD112R, in advanced solid tumors. The company also plans to initiate a US trial for its XPO1 inhibitor JS110 after gaining FDA…
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Alpha Biopharma Completes EVEREST Trial for Zorifertinib in EGFR+ NSCLC with CNS Metastases
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Shanghai-based Alpha Biopharma announced the completion of the last patient visit in the Phase II/III EVEREST study for its next-generation EGFR inhibitor zorifertinib, targeting EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with central nervous system (CNS) metastases. Topline data is expected by the end of 2022. Study DetailsThe multi-regional…
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Sorrento Therapeutics’ Abivertinib Shows Positive Long-Term Data in NSCLC Trial
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Sorrento Therapeutics Inc. (OTCMKTS: SRNE) announced positive long-term results for its third-generation EGFR inhibitor abivertinib in a pivotal trial for advanced non-small cell lung cancer (NSCLC). The study, conducted exclusively in China, enrolled 209 patients with EGFR-mutated lung cancer previously treated with first-generation EGFR inhibitors. Trial Results The data is…
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Porton Biologics and Royaltech Med Partner on Bacterial and mRNA Drug Platforms
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China-based contract development and manufacturing organization (CDMO) Suzhou Porton Biologics Ltd has partnered with Suzhou Royaltech Med Co., Ltd to establish bacterial (Listeria) and mRNA drug platform technologies. The collaboration aims to integrate both firms’ resources and capabilities, though financial terms were not disclosed. Company Profiles Strategic OutlookThe partnership will…
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Ranok Therapeutics Doses First Patient in RNK05047 Study for BRD4-Targeted Cancers
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Ranok Therapeutics Co., Ltd, a Hangzhou-based biotech firm, announced that the first patient has been dosed in the Phase I/II CHAMP-1 study (NCT05487170) of its lead drug candidate RNK05047 in the United States. The trial will evaluate the safety and optimal dosage of the potential first-in-class small-molecule degrader targeting BRD4…
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Mabwell Bioscience Receives NMPA Approval for 6MW3511 Clinical Trial in Solid Tumors
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its drug candidate 6MW3511, targeting advanced solid tumors. The trial will evaluate the drug’s efficacy and safety in patients with advanced solid tumors. Drug Profile6MW3511 is a bifunctional…
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Bio-Thera Solutions Receives NMPA Approval for BAT8008 Clinical Trial in Solid Tumors
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biotech firm, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical trial for BAT8008, its antibody-drug conjugate (ADC) targeting solid tumors. This marks the fourth product from Bio-Thera’s pipeline to advance into clinical trials. Drug ProfileBAT8008 combines a recombinant…
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BeiGene’s Tislelizumab Receives 11th NMPA Filing for First-Line Esophageal Cancer
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced that the National Medical Products Administration (NMPA) has accepted a supplementary Biologic License Application (sBLA) for its PD-1 inhibitor tislelizumab, seeking approval for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This marks the 11th market…
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BIOPSEE Series A+ Financing Confocal Microendoscope
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BIOPSEE, a Hubei-based microendoscope specialist, has raised tens of millions of renminbi in a Series A+ financing round led by Ezhou Changda Investment, Suzhou High-Tech Venture Capital, Suzhou Kejicheng Venture Capital, and SND Group. The funds will support research and development, scaled manufacturing, and clinical applications of confocal microendoscope products.…
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Scitop Bio-tech’s KEX02 Live Bacteria Therapy Gets FDA IND Approval for NSCLC
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Beijing Scitop Bio-tech Co., Ltd (SHE: 300858) announced that the US Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its live bacteria therapeutic candidate KEX02, to be tested in combination with a PD-1 inhibitor for the treatment of non-small cell lung cancer (NSCLC). About KEX02KEX02…
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InnoCare Pharma’s 2022 Interim Report Shows Strong Revenue Growth Driven by Orelabrutinib Sales
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China-based InnoCare Pharma (HKG: 9969) announced its 2022 interim financial results, reporting total revenues of RMB 246 million (USD 36 million), a 142% year-on-year (YOY) increase. The growth was primarily driven by a 115% sales volume increase of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib, which was added to the…
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Allist Pharmaceuticals Receives NMPA Approval for Furmonertinib in Exon 20 Insertion NSCLC
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that the National Medical Products Administration (NMPA) has approved a clinical trial for its furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor, targeting exon 20 insertion mutated non-small cell lung cancer (NSCLC). Drug ProfileFurmonertinib received conditional market approval from the NMPA in…
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Fosun Kite’s Yescarta CAR-T Therapy Secures New Clinical Trial Approval in China
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Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead’s Kite Pharma, has received another clinical trial approval for its anti-CD19 chimeric antigen receptor (CAR) T therapy Yescarta (axicabtagene ciloleucel). The new indication targets adult large B-cell lymphoma (r/r LBCL) that…
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mProbe Raises Funds in Series B1 Round Led by AstraZeneca and CICC
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Zhejiang-based mProbe, a protein and metabolomic marker discovery technology-based platform company, has reportedly raised an undisclosed amount of money in a Series B1 financing round. The round was solely led by AstraZeneca and CICC’s first joint global medical fund. Proceeds will be used to expand its product pipeline for women’s…
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Biocytogen Pharmaceuticals Makes HKSE Debut with USD 70 Million IPO
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Sino-US contract research organization (CRO) Biocytogen Pharmaceuticals (Beijing) Co., Ltd has completed an initial public offering (IPO) of 21.76 million shares on the Hong Kong Stock Exchange (HKSE), raising a total of HKD 549 million (USD 69.97 million). Company Overview and Core ProductsFounded in 2009, Biocytogen has a pipeline that…
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Jemincare Licenses Oral Androgen Receptor Degrader to Roche’s Genentech
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China-based Jiangxi Jemincare Group has entered into a licensing agreement with Swiss giant Roche’s Genentech. The deal grants Genentech exclusive global development and commercialization rights to Jemincare’s oral androgen receptor (AR) degrader, JMKX00299, including all related intellectual property rights. Financial TermsUnder the agreement, Genentech will pay a USD60 million upfront…
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ICT’s GCC19CART Enters US Phase I Study for Colorectal Cancer
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Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced. Study DetailsThe open-label,…
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MingMed Biotech’s Hong Kong IPO Signals Push for First-in-Class Drugs
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Guangzhou-based MingMed Biotech has officially made an initial public offering (IPO) to the Hong Kong Stock Exchange (HKSE). CICC and Credit Suisse are acting as co-sponsors. Company OverviewThe innovation-driven pharmaceutical company is focused on the self-discovery and development of potential first-in-class (FIC) drugs. These drugs aim to address major unmet…
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Junshi Biosciences’ JunMaiKang Biosimilar Gets NMPA Approval Filing
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China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been accepted by the National Medical Products Administration (NMPA). In addition, the NMPA also accepted a clinical trial filing for…
