-
Allogene Overland Biopharm Completes State-of-the-Art AlloCAR T Facility in Shanghai
•
Allogene Overland Biopharm, a joint venture between Overland Pharmaceuticals and Allogene Therapeutics, Inc. (NASDAQ: ALLO), has announced the completion of its state-of-the-art AlloCAR T manufacturing facility in Shanghai, China. This marks a significant milestone in the company’s efforts to expand its cell therapy production capabilities. State-of-the-Art GMP FacilityThe new 68,000…
-
Shandong Buchang Partners with REMD Bio for Bispecific Antibody Development
•
China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) has announced a co-development and licensing agreement with US-headquartered REMD Biotherapeutics Inc. and its subsidiary Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. Under the agreement, REMD Bio will grant Luzhou Buchang an exclusive license for REMD-290 in mainland China and Russia. Agreement Details…
-
Eucure Biopharma Partners with ISU ABXIS to Develop Tri-Specific Antibodies Using YH003
•
Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen, has entered into a partnership agreement with South Korea-based ISU ABXIS Co., Ltd (ISU ABXIS, KOSDAQ: 086890). Under the agreement, ISU ABXIS has been granted the use of Eucure’s YH003 sequence to develop multiple tri-specific antibodies for the…
-
Zhejiang Medicine’s ARX788 Advances to Phase II Study for HER2-Positive Cholangiocarcinoma
•
China-based Zhejiang Medicine Co., Ltd (SHA: 600216) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its ARX788, an anti-HER2 monoclonal antibody conjugate with AS269, in patients with HER2-positive cholangiocarcinoma. This approval marks a significant step…
-
Simcere’s SIM0235 Begins US Phase I Trial for Anti-Tumor Therapy
•
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the enrollment of the first patient in a Phase I clinical study for its novel anti-tumor drug candidate SIM0235 (formerly SIM1811-03) in the United States. This marks a significant milestone in the global development of the drug. SIM0235: Mechanism and PotentialSIM0235 is…
-
Sanofi’s Q3 Sales Rise 9% on Dupixent and Flu Vaccine
•
French pharmaceutical major Sanofi (NASDAQ: SNY) released its Q3 2022 financial report, recording EUR 12.482 billion (USD 12.394 billion) in global net sales, up 9% year-on-year (YOY) in constant exchange rates. The growth was driven by strong performances from Dupixent (dupilumab) and its flu vaccine. Within the total sales, the…
-
Novartis’ Cosentyx Gains Approval for New Doses in China
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval for two new specifications of Cosentyx (secukinumab) in China. The new 300mg and 75mg prefilled syringe forms are approved for pediatric psoriasis in patients aged six years and above with moderate to severe plaque psoriasis eligible for systemic treatment…
-
XtalPi Partners with Janssen to Accelerate Drug Discovery
•
China-based XtalPi, Inc. has announced a research collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to deliver chemical matter with validated binding affinities and desirable property profiles. The collaboration was facilitated by Johnson & Johnson Innovation LLC. Collaboration DetailsUnder the agreement, XtalPi will…
-
NMPA Approves Kyowa Hakko Kirin’s Mogamulizumab for Sezary Syndrome and Mycosis Fungoides
•
Kyowa Hakko Kirin China Pharmaceutical Co., Ltd’s mogamulizumab, a first-in-class chemokine receptor type 4 (CCR4) monoclonal antibody (mAb), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent or refractory Sezary syndrome (SS) or advanced (III/IV) mycosis fungoides (MF) who have previously…
-
NMPA Grants Second Approval to Henlius’ Serplulimab for Lung Cancer
•
The National Medical Products Administration (NMPA) has granted a second marketing approval to HaiSiZhuang (serplulimab), a programmed death-1 (PD-1) inhibitor developed by Shanghai Henlius Biotech (HKG: 2696). The drug is now approved for the treatment of first-line squamous non-small cell lung cancer (sqNSCLC). Previous Approvals and Clinical ProgressSerplulimab was initially…
-
Innovent’s CLDN18.2 ADC IBI343 Begins Phase I Trial in Australia
•
Innovent Biologics Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study for its IBI343, a CLDN18.2 antibody drug conjugate (ADC), in Australia. This marks the first ADC from the Chinese biotech company to enter clinical trials. Phase I Clinical Study DesignThe open-label, multi-center Phase…
-
Ascletis Signs Pact with Pfizer China for Ritonavir Tablets
•
Ascletis Pharma Inc. (HKG: 1672) announced that its wholly-owned subsidiary Ascletis Pharmaceuticals Co., Ltd has entered into a five-year license and supply agreement with Pfizer Investment Co., Ltd, the China unit of US-based Pfizer Inc. The agreement relates to the ritonavir 100 mg film-coated tablet, a key component of Paxlovid…
-
Eli Lilly Cancels Licensing Deal for Fosun Pharma’s FCN-338
•
Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its US partner Eli Lilly has decided to cancel the licensing deal struck with its subsidiary Fochon Pharmaceuticals Ltd in relation to FCN-338, a selective B-cell lymphoma 2 (Bcl-2) small-molecule inhibitor. The decision was cited as a “product…
-
Junshi Biosciences Reports 55% Drop in Q3 Revenues
•
Shanghai-based biotech Junshi Biosciences (HKG: 1877) released its financial report for the third quarter of 2022, showing revenues over the nine months down 55.18% year-on-year (YOY) to RMB 1.218 billion (USD 167.2 million). The decline was primarily due to decreasing technology licensing income, which could not be offset by increasing…
-
Shanghai Duoning Bio Partners with Lisure for Disposable Biopharma System
•
China’s Shanghai Duoning Biotechnology Co., Ltd has entered into a partnership with compatriot firm Lisure Inc. to jointly develop and commercialize a disposable-use system for biopharmaceutical applications. The collaboration aims to leverage the combined expertise of both companies in process equipment and life sciences to create innovative solutions for the…
-
Santhera and ReveraGen Submit NDA for Vamorolone in Duchenne Muscular Dystrophy
•
Swiss firm Santhera Pharmaceuticals and US-based ReveraGen BioPharma, Inc have announced the rolling submission of a New Drug Application (NDA) for vamorolone in Duchenne Muscular Dystrophy (DMD) with the US FDA. The drug, with China rights owned by China-based Sperogenix Therapeutics, is expected to enter the US market during the…
-
Innovent’s Tyvyt Approved for New Gastric Cancer Indication by NMPA
•
China-based Innovent Biologics, Inc. (HKG: 1801) and its partner Eli Lilly & Co. (NYSE: LLY) announced that the PD-1 inhibitor Tyvyt (sintilimab) has been approved by the National Medical Products Administration (NMPA) for a new indication. The drug is now approved to treat first-line unresectable locally advanced, recurrent, or metastatic…
-
Zhejiang Huahai Receives FDA ANDA Approval for Generic Tecfidera
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US FDA for its generic version of Biogen’s Tecfidera (dimethyl fumarate). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Tecfidera: Drug Profile and Market ContextTecfidera is…
-
Novartis Expands Strategic Collaboration with Bo’Ao Lecheng Pilot Zone
•
Novartis (NYSE: NVS) announced a further strategic collaboration with the Bo’Ao Lecheng Medical Tourism Pilot Zone, where it will establish a Novartis Hainan office and a real-world study center. The initiative aims to strengthen cooperation and exchange in real-world studies and clinical drug research and development, as well as promote…
-
Salubris Partners with Alpha Molecular for AI-Driven Obesity Drug Development
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has entered into a partnership with compatriot firm Shenzhen Alpha Molecular Technology Co., Ltd to enhance the artificial intelligence (AI)-empowered research and development of obesity drugs. The collaboration aims to leverage the combined strengths of both companies in the field of drug…
