-
Clover Biopharmaceuticals Begins Phase III Trial for COVID-19 Booster SCB-2019
•
China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the immunization of the first group of patients in a double-blind, randomized, controlled Phase III clinical study. The trial is assessing the safety and immunogenicity of its COVID-19 vaccine candidate SCB-2019 (CpG 1018/Alum) as a booster shot. Participants previously received two doses…
-
InventisBio’s KRAS G12C Inhibitor D-1553 Earns CDE Breakthrough Therapy Status
•
China-based InventisBio (Shanghai) Co., Ltd announced receiving breakthrough therapy designation (BTD) status for its KRAS G12C inhibitor D-1553 from the Center for Drug Evaluation (CDE), marking the first such recognition in China. Drug Profile and Clinical TrialsD-1553 is a highly efficient and selective KRAS G12C inhibitor undergoing a global multi-center…
-
CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
•
China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a Phase I single-dose escalation study for its pipeline drug candidate CAN106, a long-acting monoclonal antibody (mAb) targeting C5 of the complement system. The results were unveiled at the European Hematology Association (EHA) congress in Singapore.…
-
Zai Lab’s Repotrectinib Earns Two Breakthrough Therapy Designations in China for ROS1+ NSCLC
•
China-based biopharma Zai Lab Ltd (NASDAQ: ZLAB) announced receiving two breakthrough therapy designations (BTDs) from the Center for Drug Evaluation (CDE) for its repotrectinib based on positive Phase I/II TRIDENT-1 study results. The designations cover ROS1 positive metastatic non-small cell lung cancer (NSCLC) patients previously treated with one frontline ROS1…
-
Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
•
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…
-
Kangpu Biopharmaceuticals Begins Phase IIa Trial of KPG-818 for Systemic Lupus Erythematosus
•
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…
-
Pfizer’s Lorbrena Receives First Prescription in China for NSCLC Treatment
•
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…
-
Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
•
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…
-
Pfizer’s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis
•
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…
-
Huadong Medicine’s SaiYueXin Receives NMPA Approval for Pediatric Psoriasis Treatment
•
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…
-
Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
•
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…
-
Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
•
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…
-
Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
•
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…
-
Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
•
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…
-
Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
•
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)…
-
Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
•
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…
-
Hanx Biopharmaceuticals’ HX009 Receives NMPA Clinical Trial Approval for PD-1/CD47 Bispecific Antibody
•
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…
-
Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
•
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…
