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Ascletis Pharma Doses First Patient in China’s Phase II Trial for HIV-1 Treatment with ASC22
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the dosing of the first patient in its Phase II clinical trial for ASC22 (envafolimab) in combination with anti-retroviral therapy (ART) for the immune restoration and functional cure of human immunodeficiency virus 1 (HIV-1) infection. This trial marks a significant step forward in…
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Jixing Pharmaceuticals’ Aficamten Receives CDE Approval for Phase III HCM Study
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China-based Ji Xing Pharmaceuticals announced receiving approval from the Center for Drug Evaluation (CDE) to initiate a Phase III clinical study for its aficamten (CK-3773274) in symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This study is part of the global multi-center SEQUOIA-HCM trial. Drug Profile and MechanismAficamten is a next-generation cardiac myosin…
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BDgene Advances CRISPR-Based BD111 for Herpes Keratitis with IND Filing
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Shanghai BDgene Technology Co., Ltd has completed efficacy and preliminary safety studies for BD111, its CRISPR-Cas9 in vivo-based therapy for herpes simplex virus (HSV)-related keratitis (HSK). The company plans to file for Investigational New Drug (IND) approval and was awarded orphan drug designation (ODD) status in the US last week.…
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Bayer’s Kerendia Approved by China’s NMPA for Diabetic Kidney Disease
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The National Medical Products Administration (NMPA) has approved Bayer’s (ETR: BAYN) Category 1 drug Kerendia (finerenone) for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes. This approval marks a significant advancement in the treatment of diabetic kidney disease, offering a new option to slow disease progression…
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Hengrui Medicine’s SHR3680 Approved for High Burden Metastatic Prostate Cancer
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China’s Hengrui Medicine Co., Ltd. (SHA: 600276) announced that its Category 1 drug SHR3680 has received conditional approval from the National Medical Products Administration (NMPA) via priority review procedures. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. Mechanism and AdvantagesSHR3680…
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Akeso Biopharma’s Cadonilimab Approved for Cervical Cancer Treatment
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China-based biotech company Akeso Biopharma (HKG: 9926) announced that its self-discovered bispecific antibody (BsAb) cadonilimab (AK104) has received conditional market approval from the National Medical Products Administration (NMPA). The drug is indicated for the treatment of recurrent or metastatic cervical cancer that has failed previous platinum-based chemotherapy. Drug Profile and…
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Humanwell Healthcare Wins NMPA Approval for RFUS-144 in Pain Management
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 drug RFUS-144, designed to relieve pain and itching. This marks a significant step forward in the company’s efforts to develop innovative therapies for…
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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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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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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…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKG: 1801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clinical Trial Approval for PD-1/CD47 Bispecific Antibody
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China-based Hanx Biopharmaceuticals Co., Ltd has announced that its self-developed anti PD-1/CD47 bispecific antibody drug, HX009, has received a clinical trial notice from the National Medical Products Administration (NMPA) on October 30, 2019 (Acceptance Number: CXSL1900098). This follows the drug’s ethical review approval in Australia in July, where Phase I…
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Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
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Shanghai Roche Pharmaceuticals Ltd. made headlines in March with the launch of its lung cancer treatment, Erlotinib, in the Chinese market. This targeted therapy is designed for patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite standard chemotherapy. Erlotinib’s mechanism of action involves the specific…
