-
Shouyao Holdings Receives Approval for CT-3505 ALK Inhibitor Study in NSCLC
•
Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) announced it has received ethical approval from the Cancer Institute and Hospital at the Chinese Academy of Military Science to conduct a Phase I/II clinical study (CT-3505-I-01) of its CT-3505 in patients with ALK-positive non-small cell lung cancer (NSCLC). Drug ProfileCT-3505, an…
-
InnoCare Pharma Doses First Patient in ICP-488 Study for Autoimmune Diseases
•
China-based InnoCare Pharma (HKG: 9969) announced that the first subject has been dosed in a clinical study for ICP-488, its TYK2 JH2 allosteric inhibitor. The drug is being developed for autoimmune diseases such as psoriasis and inflammatory bowel disease (IBD). Mechanism of ActionICP-488 is a potent and selective inhibitor of…
-
HutchMed Initiates China Bridging Study for Tazverik in Follicular Lymphoma
•
HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a bridging study for Tazverik (tazemetostat) in China, with the first patient dosed on July 29, 2022. The multi-center, open-label, Phase II study (NCT05467943) will evaluate the drug’s efficacy, safety, and pharmacokinetics in relapsed/refractory follicular lymphoma (FL). Drug BackgroundTazverik, an EZH2…
-
Eccogene Receives FDA Approval for ECC4703 Phase I Study in NASH and Dyslipidemia
•
Shanghai-based biopharmaceutical company Eccogene announced it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial for ECC4703, a thyroid hormone receptor (THR) agonist. The study will assess the drug’s safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and subjects with elevated…
-
Lion TCR Enrolls First Patient in LioCyx-M004 Study for HBV-Related Liver Cancer
•
Singapore-based clinical-stage biotech Lion TCR announced the enrollment of the first subject in a clinical study for LioCyx-M004, its autologous T-cell therapy targeting HBV-related hepatocellular carcinoma (HCC). The therapy uses mRNA-engineered T-cells to recognize and destroy hepatitis B virus (HBV)-related liver cancer cells. Therapy DetailsLioCyx-M004 leverages Lion TCR’s RNA technology…
-
Grand Pharma’s TLX591-CDx and TLX250-CDx Advance in China with NMPA Review
•
Grand Pharmaceutical Group Limited (HKG: 0512) announced that the National Medical Products Administration (NMPA) has accepted Investigational New Drug (IND) filings for TLX591-CDx (Illuccix) and TLX250-CDx, its radiopharmaceuticals for prostate cancer and clear cell renal cell carcinoma (ccRCC) diagnostics. Drug Profiles China Trials Global DevelopmentTLX591-CDx is filed for marketing in…
-
Sanjin Pharma’s Subsidiary Gets FDA Nod for BC007 Cancer Drug Trial
•
China-based Guilin Sanjin Pharmaceutical Co. Ltd (SHE: 002275) announced that its subsidiary, Dragon Boat Pharmaceutical (Shanghai) Co., Ltd, has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I clinical study of BC007, a bispecific antibody (BsAb) targeting CLDN18.2 and CD47, in patients with solid…
-
Innovent and Laekna Dose First Patient in Afuresertib and Tyvyt Study for PD-1 Resistant Tumors
•
China’s Innovent Biologics Inc. (HKG: 1801) and partner Laekna Therapeutics Shanghai Co., Ltd announced that the first patient has been dosed in a Phase I/II clinical study (NCT05383482) evaluating afuresertib combined with Tyvyt (sintilimab) plus chemotherapy in solid tumors resistant to PD-1/PD-L1 inhibitors. Study DetailsThe multi-center, single-arm, open-label, dose-escalation study…
-
Dongcheng Pharmaceutical Gets NMPA Green Light for PSMA PET Imaging Drug
•
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for a radioactive in vivo diagnostic drug. The drug is intended for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in…
-
CanSino Biologics Launches Menhycia Meningococcal Vaccine in Six Provinces
•
China-based CanSino Biologics (HKG: 6185) announced the launch of its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4, trade name: Menhycia), marking the debut of China’s first quadrivalent meningococcal conjugate vaccine. The vaccine is now available in Anhui, Shandong, Fujian, Guangxi, Heilongjiang, and Yunnan. Vaccine DetailsMenhycia covalently binds to meningococcal serogroups A,…
-
Mabwell Bioscience Gets FDA Approval for Nectin-4 ADC 9MW2821 in Solid Tumors
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a clinical study of its antibody drug conjugate (ADC) 9MW2821, targeting Nectin-4, in solid tumors. The drug is the first of its kind to enter clinical trials…
-
LaNova Medicines Gets FDA Green Light for LM-305 Myeloma Study
•
Shanghai-based cancer therapy developer LaNova Medicines Ltd announced it has received approval from the U.S. Food and Drug Administration (FDA) to conduct an open-label, multi-center Phase I/II study of LM-305, an antibody drug conjugate (ADC) targeting GPRC5D, in patients with multiple myeloma (MM). Drug ProfileLM-305 is the first GPRC5D-targeting ADC…
-
CSPC Pharmaceutical’s Albumin-Bound Docetaxel Receives Orphan Drug Designation for Gastric Cancer
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received an orphan drug designation (ODD) from the National Medical Products Administration (NMPA) for its docetaxel (albumin-bound) in gastric cancer, including esophagogastric junction cancer. Product ProfileThe product uses innovative human albumin encapsulation technology to deliver docetaxel nanoparticles into the…
-
Hybio Pharmaceutical’s Liraglutide Filing Accepted by NMPA, Becomes Domestic Leader in GLP-1 Analog
•
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced that its market filing for liraglutide, a Category 2.2 chemical drug, has been accepted for review by the National Medical Products Administration (NMPA). Hybio is now the only domestic firm to complete clinical trials via chemical synthesis and file for marketing of…
-
Roche’s Rozlytrek Wins NMPA Approval for NTRK Fusion Gene-Positive Tumors
•
Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tumor-agnostic therapy Rozlytrek (entrectinib). The drug is approved for treating solid tumors in patients aged 12 and older who carry a neurotrophic tyrosine receptor kinase (NTRK) fusion gene and have…
-
Kira Pharmaceuticals’ KP104 Receives Orphan Drug Designation for PNH Treatment
•
Sino-US biotech Kira Pharmaceuticals announced that it has received an Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for KP104, its first-in-class biologic for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). Drug ProfileKP104 is a bifunctional biologic designed to selectively block the alternative and terminal pathways…
-
Takeda’s Alunbrig Prescribed in China for ALK+ NSCLC Treatment
•
Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502) announced that its lung cancer therapy Alunbrig (brigatinib) has been prescribed in China for the first time, marking its official commercialization and clinical application in the country. The drug was approved in March 2023 to treat anaplastic lymphoma kinase (ALK)-positive locally advanced or…
-
MabPharm’s CMAB015 Biosimilar Receives NMPA Approval for Clinical Study
•
Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its CMAB015, a biosimilar of Novartis’ Cosentyx (secukinumab). The study will target psoriasis and ankylosing spondylitis. Drug ProfileCosentyx was first approved…
-
Nestle Launches China’s First Cancer-Focused FSMP Product Oral Impact Su Yi Su
•
Switzerland-based Nestle announced the launch of China’s first “foods for special medical purposes” (FSMP) product specifically designed for cancer patients. Branded as Oral Impact Su Yi Su, the product provides a non-inflammatory diet for individuals recovering from cancer treatment, containing arginine, fish oil, omega-3, and nucleotides in addition to standard…
-
Nuance Pharma Initiates Phase I Study for Ketorolac IV Infusion (NTM-001)
•
China-based Nuance Pharma announced the initiation of subject enrollment and the first drug infusion in a Phase I clinical study for its ketorolac for IV infusion (NTM-001), a non-opioid analgesic co-developed with US-based Neumentum Inc. Study DetailsThe Phase I study enrolled 16 healthy subjects, who have completed the 96-hour sample…
