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Bristol-Myers Squibb Launches Reblozyl in China for β-Thalassemia Treatment
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US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the commercial launch of its first-in-class erythrocyte maturation agent, Reblozyl (luspatercept), in China. The product, filed by its subsidiary Celgene, received approval in China in January 2022 for the treatment of adult β-thalassemia patients who require regular red blood cell…
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Clover Biopharmaceuticals Initiates SCB-219M Clinical Study for CIT Treatment
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the first subject dosing in a Phase I clinical study for its in-house developed thrombopoietin receptor agonist, SCB-219M. This multi-center, dosage escalation and expansion study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of SCB-219M in CIT patients. Interim safety…
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Changchun High & New Technology’s Jinnamab Approved for AOSD Clinical Study by US FDA
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) has announced that it has received approval from the US FDA to conduct a clinical study for its jinnamab in adult-onset still disease (AOSD). Understanding AOSDAOSD, originally referring to the systemic onset of juvenile chronic arthritis, can also occur…
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BeiGene’s Brukinsa Faces Three-Month FDA Approval Delay for CLL/SLL Indication
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China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The US Food and Drug Administration (FDA) has pushed back the…
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Junshi Biosciences Receives NMPA Approval for Fourth-Generation EGFR Inhibitor WJ13404
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Shanghai-based biotech Junshi Biosciences (HKG: 1877, SHA: 688180) has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for WJ13404, a fourth-generation EGFR inhibitor developed in collaboration with Wigen Biomedicine. This approval positions Junshi Biosciences at the forefront of advanced non-small cell lung cancer (NSCLC)…
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Innovent Biologics Receives BPOM Approval for Bevagen in Indonesia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced receiving indication approvals from Indonesia’s Badan Pengawas Obat dan Makanan (BPOM) for its Bevagen (bevacizumab), a biosimilar version of Avastin. This approval marks a significant milestone for Innovent as it expands its market presence in Southeast Asia. Approved IndicationsInnovent’s bevacizumab has been…
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Innovent Biologics’ IBI306 Accepted for Review by China’s NMPA for Hypercholesterolemia
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China-based Innovent Biologics Inc. (HKG: 1801) has announced that a New Drug Application (NDA) filing for its recombinant fully human anti-PCSK-9 monoclonal antibody (mAb) IBI306 has been accepted for review by the National Medical Products Administration (NMPA). The application covers the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial…
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Clover Biopharmaceuticals Begins Phase III Trial for COVID-19 Booster SCB-2019
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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…
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InventisBio’s KRAS G12C Inhibitor D-1553 Earns CDE Breakthrough Therapy Status
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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…
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CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
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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.…
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Zai Lab’s Repotrectinib Earns Two Breakthrough Therapy Designations in China for ROS1+ NSCLC
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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…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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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…
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Kangpu Biopharmaceuticals Begins Phase IIa Trial of KPG-818 for Systemic Lupus Erythematosus
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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…
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Pfizer’s Lorbrena Receives First Prescription in China for NSCLC Treatment
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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…
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Ascentage Pharma’s Lisaftoclax Shows Promising Results in Phase I Trial for Non-Hodgkin Lymphoma
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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…
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Pfizer’s Ritlecitinib Earns CDE Breakthrough Designation for Ulcerative Colitis
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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…
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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…
