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The Center for Drug Evaluation (CDE) website has indicated that DB-1303, a HER2 targeted antibody drug conjugate (ADC) developed by Duality Biologics, a biotech company with operations in both the United States and China, is poised to receive breakthrough therapy designation (BTD). The proposed use for the treatment is for…
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Germany’s Bayer (ETR: BAYN) has released its financial results for 2023, marking a year of declining sales that culminated in a 1.2% year-on-year (YOY) drop in constant currency and portfolio-adjusted terms, reaching €47.6 billion (USD 51.7 billion). The Pharmaceuticals segment generated €18.1 billion (USD 19.6 billion) with a 0.4% decline…
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
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The European Medicines Agency (EMA) has accepted for review two oncology filings for the antibody-drug conjugate (ADC) datopotamab deruxtecan, developed jointly by UK-based AstraZeneca (AZ; NASDAQ: AZN) and Japan’s Daiichi Sankyo (TYO: 4568). The indications submitted for review are for the treatment of locally advanced or metastatic nonsquamous non-small cell…
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-7058, an innovative and selective drug candidate, in patients with advanced solid tumors harboring the KRAS G12C mutation. This development marks a significant step for Hengrui Pharmaceuticals…
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Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently…
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the results of a matching-adjusted indirect comparison (MAIC) between its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), and acalabrutinib in terms of efficacy. The comparison is based on data from the Phase III ALPINE and Phase III ASCEND studies, which…
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The China Center for Drug Evaluation (CDE) website has indicated that the market approval filing for Bristol-Myers Squibb’s (BMS, NYSE: BMY) combination regimen of Yervoy (ipilimumab) and Opdivo (nivolumab) for first-line unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) is on track to receive…
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The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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Shanghai Haihe Pharmaceutical Co., Ltd has entered into a licensing agreement with Taiho Pharmaceutical Co., Ltd, granting the Japanese company exclusive rights to develop, manufacture, and commercialize glumetinib, a MET-targeted tyrosine kinase inhibitor (TKI), in Japan and other Asian countries (excluding China) and Oceania. Haihe has already submitted a market…
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Bcl-2 inhibitor FCN-338 in combination with the BTK inhibitor FCN-647, targeting chronic lymphocytic leukemia/small lymphocytic lymphoma. FCN-338…
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval for Pepaxto (melphalan flufenamide), a drug initially approved for use in combination with dexamethasone to treat certain patients with multiple myeloma (MM). The decision stems from two key factors: (1) a confirmatory study, conducted as…
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Chia Tai Tianqing, a renowned biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) has accepted for review a new indication filing for its anlotinib (trade name: FOCUS V) in combination with the anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The proposed indication…
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…