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The Center for Drug Evaluation (CDE) of China has indicated that Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) is on track to receive Breakthrough Therapy Designation (BTD) for its bispecific antibody GR1803. This designation is for the treatment of recurrent refractory multiple myeloma (RRMM) in patients who have previously undergone…
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Lepu Biotechnology Co., Ltd (HKG: 2157), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its pipeline candidate, MRG003. This designation highlights the drug’s potential in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), a significant…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug, 177LuLNC1011. This novel therapeutic is a prostate specific membrane antigen (PSMA)-targeted radioactive in vivo treatment…
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, in collaboration with Sanegene Bio USA Inc., has announced the dosing of the first patient in a Phase I First-in-Human (FIH) clinical trial for their siRNA drug candidate, IBI3016. This investigational therapy targets angiotensinogen (AGT) and is being…
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China-based Walvax Biotechnology Co., Ltd (SHE: 300142) has achieved a significant milestone with its bivalent human papillomavirus vaccine, which has received pre-qualification (PQ) status from the World Health Organization (WHO). This vaccine, designed to prevent cervical cancer and other diseases associated with high-risk HPV types 16 and 18, was commercially…
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China-based Akeso Biopharma (HKG: 9926) has reached a clinical milestone with the dosing of the first patient in a Phase II study for its investigational drug ligufalimab (AK117) in the United States. The study is a randomized, placebo-controlled, global multi-center trial that combines ligufalimab with azacitidine for the treatment of…
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US pharmaceutical giant AbbVie Inc. (NYSE: ABBV) has announced the successful completion of its acquisition of Cerevel Therapeutics (Nasdaq: CERE), a biotech company based in Cambridge, Massachusetts. AbbVie will pay $45.00 per share for Cerevel, totaling an approximate acquisition value of $8.7 billion. The transaction, initially announced in December 2023,…
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a leading biopharmaceutical company based in China, has announced the first dosing in a Phase I clinical study for AU409, an oral small molecule drug. The drug was discovered by Auransa Inc. using the AI platform SMarTR Engine and will be manufactured by Lee’s…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced the successful completion of a Phase II clinical study for its Category 1 product candidate, jacktinib tablets, in the treatment of idiopathic pulmonary fibrosis (IPF). The study demonstrated that jacktinib tablets effectively delayed the decline…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review a new indication filing for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb), benmelstobart (TQB2450). The filing seeks regulatory approval for the use…
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted for review the second New Drug Application (NDA) for its investigational drug mazdutide (IBI362). Mazdutide is a novel glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR)…
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GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult…
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), a Chinese pharmaceutical company, has announced the commencement of a Phase III clinical study for its drug candidate THDB0225, a biosimilar to Novo Nordisk’s semaglutide and Ozempic, used for the treatment of type 2 diabetes patients with inadequate glycemic control following metformin therapy. The multi-center,…
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The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the…
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Germany-based BioNTech SE (NASDAQ: BNTX) has announced that its mRNA cancer immunotherapy BNT111, in combination with the programmed death-1 (PD-1) inhibitor Libtayo (cemiplimab), has achieved the primary endpoint in a Phase II clinical trial. The study, part of a collaboration with Regeneron, is assessing the combination and monotherapies in treating…
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company, has announced that it has received registration approval from Algerian authorities for two of its insulin products: the insulin aspart injection pre-filled pen and the insulin aspart 30 injection pre-filled pen. These products are slated to be manufactured locally by…
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Cutia Therapeutics (HKG: 2487), a company specializing in dermatological treatments, has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for CU-30101, a topical lidocaine and tetracaine cream. This pharmaceutical product is designed to provide rapid and long-lasting anesthetic effects, leveraging the…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the US Food and Drug Administration (FDA) has granted priority review status to Scemblix (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP). Scemblix, the first molecule to specifically target the ABL Myristoyl…