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China-based Youjia (Hangzhou) Biomedical Technology Co., Ltd. has signed a licensing agreement with compatriot firm Livzon Pharmaceutical Group Inc. (HKG: 1513), marking a significant step in the global development of a novel small interfering RNA (siRNA) product for the treatment of metabolic diseases. Terms of the Licensing AgreementUnder the agreement,…
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Germany-based Bayer AG (ETR: BAYN) has announced plans to acquire HiDoc Technologies GmbH in the first quarter of 2025, marking a significant step in the company’s expansion into digital health solutions. Alongside this acquisition, Bayer is initiating the commercialization of its digital health application, Cara Care, which is designed to…
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) has published results from the Phase III EMBER-3 study for its drug imlunestrant in patients with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC). The study focused on patients whose disease progressed on…
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Germany-based Fresenius Kabi, a leading name in healthcare, has struck an accord with Ori Biotech Ltd, a London-headquartered cell and gene therapy (CGT) manufacturing technology leader. The partnership aims to integrate the IRO platform with Fresenius Kabi’s Cue and Lovo Cell Processing Systems, marking a significant step in the advancement…
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) have jointly presented preliminary data from the ongoing Phase Ib portion of the TACTIVE-U sub-study at the 2024 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The study assesses vepdegestrant in combination with Verzenios (abemaciclib) in patients with…
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UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has formed two multi-program strategic partnerships with compatriot firm Relation Therapeutics. These deals are focused on the identification and validation of novel therapeutic targets for fibrotic diseases and osteoarthritis, with GSK obtaining global development and commercialization rights to any resultant targets. Financial Terms…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) presented updated results from the pivotal Phase III NATALEE study for its Kisqali (ribociclib) at the 2024 San Antonio Breast Cancer Symposium (SABCS). The study provides significant insights into the efficacy of Kisqali in combination with endocrine therapy (ET) for patients with receptor-positive/human epidermal…
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Arcalyst (rilonacept), a treatment for recurrent pericarditis (RP). This marks an expansion of the drug’s application in addressing autoimmune diseases. Rilonacept’s Mechanism and Global ApprovalsRilonacept is a recombinant…
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China-based IMEIK Technology Development Co., Ltd (SHE: 300896) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human hyaluronidase for injection. The study aims to explore the use of the drug to promote the diffusion of subcutaneous infusion as an…
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Guangzhou Patronus Biotech Co., Ltd., a vaccine start-up specializing in respiratory and infectious diseases, has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its recombinant respiratory syncytial virus (RSV) vaccine (CHO cells), LYB005. LYB005’s U-VLP Technology and Clinical ProgressLYB005 is an RSV vaccine…
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China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its SRD4610, an in-house developed compound Chinese medicine, for the treatment of amyotrophic lateral sclerosis (ALS). This designation highlights the potential impact of SRD4610 in…
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China-based rare disease specialist Sperogenix Therapeutics Limited has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Agamree (vamorolone), which is used to treat patients with Duchenne muscular dystrophy (DMD). This marks a significant milestone as Agamree becomes the first DMD drug approved in China,…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for its two drug candidates, SHR-4394 and HRS-3802. SHR-4394: A Novel Therapeutic Biologic for Prostate CancerSHR-4394 is an in-house developed therapeutic biologic product, with its target undisclosed, currently under…
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical Products Administration (NMPA) has approved an extended indication for its antifungal agent Noxafil (posaconazole) to include pediatric patients in the prevention and treatment of fungal infections. This approval covers two dosage forms: enteric-coated tablets and…
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The website of China’s National Medical Products Administration (NMPA) has indicated that the marketing filing for Zynlonta (loncastuximab tesirine), a collaboration between China’s Overland Pharmaceuticals and Swiss firm ADC Therapeutics SA (NYSE: ADCT), has been approved. This approval allows the CD19-targeted antibody-drug conjugate (ADC) to be used for treating adult…
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China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion…
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China-based Contract Development and Manufacturing Organization (CDMO) Porton Pharma Solutions (SHE: 300363) has announced a strategic partnership with OD Kingsley Life Sciences (Yixing) Co., Ltd, a joint venture between Kingsley Pharmaceutical and Hong Kong-headquartered OD Therapeutics Limited. The partnership aims to leverage Porton’s expertise in Chemistry, Manufacturing, and Controls (CMC)…
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US-based Stereotaxis, Inc. (NYSEAMERICAN: STXS) and its Chinese partner Shanghai MicroPort EP Medtech Co., Ltd. (SHA: 688351, MicroPort EP) have jointly announced the receipt of marketing approval from the National Medical Products Administration (NMPA) of China for their co-developed Magbot magnetic navigation ablation catheter. This approval marks a significant milestone…