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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its neratinib maleate active pharmaceutical ingredient (API) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the company’s efforts to bring this important drug to the…
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The National Healthcare Commission and the National Administration of Traditional Chinese Medicine have released a notification indicating the inclusion of Henan Genuine Biotech Co., Ltd’s COVID-19 therapy azvudine in the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (9th Edition). The drug is now approved for the treatment of adult…
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China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting HIV drug candidate CL-197 has been approved by the National Medical Products Administration (NMPA). CL-197 is a novel nucleoside reverse transcriptase inhibitor (NRTI) that inhibits reverse transcription by simulating endogenous purine nucleotides, thus having potential…
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Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its HanBeiTai, a biosimilar of bevacizumab, has been accepted for review by the Center for Drug Evaluation (CDE). The targeted indications for this application include cervical cancer, epithelial ovarian cancer, fallopian tube cancer, and…
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The National Medical Products Administration (NMPA) has released a notification regarding the initiation of electronic certificates for biologic product releases and electronic approvals of narcotic drugs, as well as the establishment of a psychotropic substances study program. These measures aim to streamline regulatory processes and enhance efficiency in the management…
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its avibactam sodium + ceftazidime product, marketed under the brand name Zavicefta, in China. The indication is for children three months and older with complex intra-abdominal infection (cIAI).…
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initiation of a Phase II/III study for its sovleplenib (HMPL-523) in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The first patient was dosed on September 30. This marks a significant step forward in the…
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced receiving a patent award from the United States Patent and Trademark Office (USPTO) for ZSP1241, a home-grown fibroblast growth factor receptor 4 (FGFR4) inhibitor. The patent, titled “Salt form and crystal form of compound as FGFR4 inhibitor and preparation method…
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its Phase III PRESERVE 2 study of the CDK4/6 inhibitor Cosela (trilaciclib) in metastatic triple-negative breast cancer (mTNBC). The study enrolled 187 patients, with interim overall survival analysis expected during the second half of 2023. PRESERVE…
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or…
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The National Medical Products Administration (NMPA) has granted another indication approval to China-based JW Therapeutics’ (HKG: 2126) Carteyva (relmacabtagene autoleucel injection). The anti-CD19 autologous chimeric antigen receptor (CAR) T-cell immunotherapy product can now be used to treat recurrent or refractory (r/r) follicular lymphoma (FL) in adults after second-line or above…
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Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been…
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China-based Sciwind Biosciences Co., Ltd has announced the initiation and first patient dosing of a Phase I clinical study for its XW014 in the United States. The double-blind, randomized, placebo-controlled, single and multiple ascending dose study is designed to assess the safety, tolerability, food effects, pharmacokinetics, pharmacodynamics, and early treatment…
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China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has been dosed in a Phase I clinical study for its Category 1 drug candidate GST-HG171. The randomized, double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy Chinese…
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced that a clinical trial filing for its first-in-class anti-tumor biologic drug SAL008 has been accepted for review by the National Medical Products Administration (NMPA). The drug, indicated for advanced solid tumors, has previously entered Phase I clinical trials in Europe.…
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Swiss pharmaceutical giant Roche’s (SWX: ROG) Herceptin (trastuzumab, subcutaneous injection) has been approved in China for the treatment of early and metastatic HER2-positive breast cancer in combination with chemotherapy. This approval marks a significant advancement in the treatment options available for patients with HER2-positive breast cancer, offering a more convenient…
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US major Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 9th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used as a monotherapy to treat hepatocellular carcinoma (HCC) previously treated with sorafenib or oxaliplatin. Approval Based…
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Eli Lilly & Co (NYSE: LLY) has secured its first approvals in China for Retevmo (selpercatinib), a RET kinase inhibitor, across three indications. The drug is now approved for the treatment of RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-mutated advanced or metastatic medullary thyroid…
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China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its novel antiviral drug ziresovir (AK0529). The study evaluated the efficacy and safety of ziresovir in hospitalized infants with respiratory syncytial virus (RSV) infection. The drug achieved its primary endpoint of a significant reduction in symptom…
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US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced positive results from the Phase III TALAPRO-2 study for its oral poly ADP ribose polymerase (PARP) inhibitor, Talzenna (talazoparib). The study evaluated the drug in combination with Xtandi (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) with or without homologous…