-
Alphamab and 3D Medicines License Envafolimab Rights to Glenmark for Multiple Regions
•
Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244), two Chinese pharmaceutical companies, have announced a licensing agreement with Glenmark Pharmaceuticals Ltd (NSE: GLENMARK). The agreement grants the Indian company exclusive development and commercialization rights to the co-developed drug envafolimab (KN035) in India, Asia Pacific (excluding Singapore, Thailand, Malaysia), Middle…
-
Phanes Therapeutics’ First-in-Class BsAb PT217 Accepted for Review by China’s CDE
•
Sino-US biotechnology company Phanes Therapeutics Inc. has announced that the Investigational New Drug (IND) filing for its potential first-in-class in-house bispecific antibody (BsAb) PT217 has been accepted for review by China’s Center for Drug Evaluation (CDE). PT217 is designed to directly kill tumor cells through the antibody-dependent cellular phagocytosis (ADCP)…
-
Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40
•
Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor…
-
BMS’s Opdivo-Yervoy Combo Cuts Cancer Progression Risk by 79% in Phase III Study
•
Bristol Myers Squibb (BMS; NYSE: BMY) has published late-stage and long-term data for its anti-PD-1 drug Opdivo (nivolumab) across various cancer indications. Early results from a Phase III trial in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) indicate that the combination of Opdivo with anti-CTLA-4…
-
Tcelltech’s B7-H3 Targeting CAR-T Therapy TX103 Gets Tacit Clinical Approval for Glioblastoma
•
The Center for Drug Evaluation (CDE) website in China has indicated that Tcelltech’s TX103, a chimeric antigen receptor (CAR) T cell therapy targeting B7-H3, has received tacit approval to proceed with clinical trials for the treatment of malignant glioblastoma. Suzhou Porton Biologics Ltd, Tcelltech’s Contract Development and Manufacturing Organization (CDMO)…
-
Merck’s Bavencio Shows Promising Survival Data in Real-World Urothelial Carcinoma Studies
•
German pharmaceutical company Merck (NYSE: MRK) has released data from real-world studies for its anti-PD-L1 biologic Bavencio (avelumab), used as a maintenance therapy in eligible patients with locally advanced or metastatic urothelial carcinoma (UC). Preliminary results indicate that the median overall survival (OS) in patients without progression after first-line chemotherapy…
-
BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
•
BriSTAR Immunotech, a clinical-stage cell therapy company based in Beijing, has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) in China for its YTS104, a specific LILRB4-targeted cell therapy based on its STAR-T platform. The targeted indications for YTS104 include recurrent/refractory acute myeloid leukemia (AML), chronic…
-
Legend Biotech’s Carvykti Files for European Approval as Second-Line MM Treatment
•
GenScipt Biotech Corp. (HKG: 1548), a China-based Contract Development and Manufacturing Organization (CDMO), through its subsidiary Legend Biotech Corporation (NASDAQ: LEGN), has announced a market approval filing in Europe for its chimeric antigen receptor (CAR)-T therapy Carvykti (ciltacabtagene autoleucel). The therapy is proposed as a second-line treatment for recurrent/refractory (R/R)…
-
Gilead’s Trodelvy Misses Primary Endpoint in Late-Stage NSCLC Trial
•
Gilead Sciences (NASDAQ: GILD) has announced that a late-stage trial for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in metastatic or advanced non-small cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS) in patients who had previously received treatment for metastatic NSCLC. Despite this setback,…
-
Novartis Lutathera Combo Therapy Shows Significant Progress in GEP-NETs
•
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced preliminary results from a Phase III study that evaluated the efficacy of radioligand therapy (RLT) Lutathera (lutetium (177Lu) oxodotreotide) in combination with the symptom-control drug octreotide as a first-line therapy for SSTR+ well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The clinical…
-
AstraZeneca’s Imfinzi Meets Primary Endpoint in Hepatocellular Carcinoma Trial
•
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced the successful completion of the primary endpoint in a Phase III trial for its anti-PD-L1 drug Imfinzi (durvalumab). The trial investigated the combination of Imfinzi with bevacizumab, originally developed by Roche (SWX: ROG) as Avastin, and transarterial chemoembolization (TACE) for embolization-eligible hepatocellular…
-
J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
•
The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
-
Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
•
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
-
InnoCare Makes Minjuvi Combo Treatment Available to Patients in China’s GBA
•
InnoCare (HKG: 9969; SHA: 688428), a China-based biopharmaceutical company, has announced that the combination treatment of Minjuvi (tafasitamab) plus lenalidomide is now accessible to patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) in the Guangdong-Hong Kong-Macao Greater Bay Area (GBA).…
-
BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
•
BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China for its programmed death-1 (PD-1) inhibitor, tislelizumab. The company is seeking regulatory approval for a new indication in the perioperative (neoadjuvant + adjuvant) treatment of patients with resectable non-small cell lung cancer (NSCLC). The Center…
-
Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
•
Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its monoclonal antibody SCTC21C, targeting CD38+ hematological malignant tumors. This development marks a significant step forward in…
-
CARsgen Therapeutics’ CT041 Shows Promising Results in Advanced Solid Tumors at ASCO GI 2024
•
China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced the presentation of interim results from the Phase Ib ELIMYN18.2 study’s dosage escalation phase for its pipeline asset, CT041. The data will be showcased at the esteemed 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI 2024). The study is…
-
Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
•
Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has registered a Phase III clinical study with Clinicaltrials.gov for its Claudin18.2-targeted antibody ASKB589. The trial will investigate the use of ASKB589 in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. The study aims…
-
Eisai and Medivir’s Combo Therapy Advances in Liver Cancer with Positive Trial Results
•
Japanese pharmaceutical company Eisai’s (TYO: 4523) kinase inhibitor Lenvima (Lenvatinib), combined with Swedish partner Medivir’s (STO: MVIR) chemotherapy fostroxacitabine bralpamide (fostrox), has demonstrated positive outcomes in an open-label Phase Ib/IIa trial for advanced hepatocellular carcinoma (HCC), Medivir announced. Following last year’s encouraging early data, these results are expected to pave…
-
Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
•
Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
