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OnCusp Therapeutics Licenses Multitude’s CDH6 ADC for Global Development
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US-based OnCusp Therapeutics has entered into a licensing agreement with China’s Multitude Therapeutics for the global development and commercialization of AMT-707 (CUSP06), a preclinical-stage cadherin-6 (CDH6) antibody-drug conjugate (ADC). OnCusp gains exclusive rights outside Greater China, while Multitude receives undisclosed upfront, milestone payments, and royalties. Scientific Rationale and Drug ProfileCDH6…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the publication of Phase I clinical study results for its Bcl-2 inhibitor lisaftoclax (APG-2575) in Chinese patients with recurrent/refractory non-Hodgkin lymphoma (r/r NHLs). The results are being released at the European Hematology Association (EHA) congress 2022 meeting. Clinical Trial ResultsThe results demonstrated that APG-2575…
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Kangpu Biopharmaceuticals Begins Phase IIa Trial of KPG-818 for Systemic Lupus Erythematosus
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Shanghai-based Kangpu Biopharmaceuticals, Ltd has announced the first patient dosing in a multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical study. The trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of KPG-818, an orally bioavailable NeoMIDES molecular glue, in patients with systemic lupus erythematosus (SLE). Mechanism and DevelopmentKPG-818…
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Shanghai MicroPort MedBot Completes World’s Furthest Remote Robot Surgery via 5G
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced the successful completion of a remote surgery performed by the Toumai endoscopic surgery robot via 5G connection between Jiangsu Province Hospital and Xinjiang Kezhou Ren Min Yiyuan. This achievement marks the world’s furthest remote robot surgery conducted to date. Toumai Robot’s…
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Pfizer’s Lorbrena Receives First Prescription in China for NSCLC Treatment
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US pharmaceutical giant Pfizer Inc. (NYSE: PFE) has announced the first prescription of its third-generation ALK inhibitor Lorbrena (lorlatinib) in Guangdong province, China. This milestone marks the official market launch of the drug for Chinese non-small cell lung cancer (NSCLC) patients, following its approval two months prior. Drug Profile and…
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HealZen Therapeutics and Hisun Partner on First-in-Class Protein Degradation Product
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Hangzhou-based HealZen Therapeutics Protein Degradation Hisun Pharmaceutical Co., Ltd. a has formed a strategic partnership with compatriot firm Zhejiang Hisun Pharmaceutical Co., Ltd. to jointly develop a first-in-class protein degradation product. The collaboration involves shared research and development (R&D) efforts, with Hisun obtaining exclusive global development and commercialization rights. Hertz…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the publication of Phase I clinical study results for its Bcl-2 inhibitor lisaftoclax (APG-2575) in Chinese patients with recurrent / refractory non-Hodgkin lymphoma (r/r NHLs) at the European Hematology Association (EHA) congress 2022. Clinical Trial ResultsThe results demonstrated that APG-2575 was well tolerated at…
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Pfizer’s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis
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The Center for Drug Evaluation (CDE) website indicates that Pfizer’s (NYSE: PFE) category 1 drug ritlecitinib (PF-06651600) has obtained breakthrough therapy designation (BTD) status for use in moderate to severe active ulcerative colitis (UC) in adults. Mechanism of ActionRitlecitinib, a Janus kinase 3 (JAK3) inhibitor, selectively inhibits JAK isoenzymes through…
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Ascletis Pharma Appoints John P. Gargiulo as Chief Business Officer to Lead Growth
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the appointment of Mr. John P. Gargiulo as its new Chief Business Officer (CBO). Formerly the North America President and CEO for Daiichi Sankyo, Gargiulo will lead Ascletis’s corporate business development and alliance management, reporting to Dr. Jinzi J. Wu, PhD, founder,…
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Beijing Winsunny Pharma Plans IPO to Boost Drug Development and Production
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China-based Beijing Winsunny Pharmaceutical Co., Ltd. has announced plans for an initial public offering (IPO) of 120 million shares on the Shanghai Stock Exchange. The proceeds, totaling RMB 1.74 billion (USD 258 million), will fund the Phase I industrialization project, research and development of novel and generic drugs, and working…
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Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged…
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Gritgen Therapeutics Secures Hundreds of Millions in A-Round Financing for Gene Therapy Pipeline
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Gritgen Therapeutics, a leading gene therapy drug developer based in Suzhou, has announced the successful completion of a A-round financing round worth several hundred million yuan. The financing was led by Sequoia China, with participation from Sunlight Insurance, Qingsong Capital, and Beijing Life Science Park Venture Fund. Existing shareholders including…
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Shenzhen-Based Pregbio Raises Funds for Non-Invasive Prenatal Gene Detection
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Pregbio, a Shenzhen-based non-invasive prenatal gene detection company, has reportedly raised an undisclosed amount of money in an angel financing round. The sole contributor to the round was ASB Ventures. The proceeds will be used to promote early screening and diagnosis of preterm labor and pre-eclampsia, non-invasive prenatal screening, and…
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Novartis Cuts Back on US Development of BeiGene’s PD-1 Inhibitor Tislelizumab
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Novartis AG (NYSE: NVS), BeiGene’s partner, revealed in its Q3 2022 earnings report that it is scaling back the US development of the programmed death-1 (PD-1) inhibitor tislelizumab. The firm no longer plans to file a New Drug Application (NDA) in the US for nasopharyngeal carcinoma (NPC) and has ended…
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Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
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Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its tropomyosin receptor kinase (TRK) inhibitor Vitrakvi (larotrectinib) in the US market following the detection of contamination by the Penicillium brevicompactum mold in the oral solution. While no adverse events have been reported, Bayer has advised…
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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
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Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
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Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
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Exegenesis Bio Secures Multi-Million Dollar Series B Financing for Gene Therapy Pipeline
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Exegenesis Bio Inc., a leading gene therapy company, has successfully completed a Series B financing round, raising tens of millions of dollars. The round was led by Legend Capital, with Boyuan Capital, Taikang Capital, and previous investors Xianfeng Qiyun and Kaitong Capital participating. The funds raised will be directed towards…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
