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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the completion of all subject enrollment in a multi-center Phase III clinical study for its Ryaltris compound nasal spray (GSP301). This compound is under evaluation as a potential treatment for seasonal allergic rhinitis (SAR) in patients aged 12 years and older.…
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China-based Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) have announced receiving approval in China to conduct a registrational study for KN026 combined with docetaxel (albumin bound) in first-line HER2 positive recurrent and metastatic breast cancer. Design and Objectives of the Phase III StudyThe randomized, controlled, open,…
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US-based Eyenovia, Inc. (NASDAQ: EYEN) has announced obtaining market approval from the US Food and Drug Administration (FDA) for its Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%. This product is indicated for inducing mydriasis during diagnostic procedures and in conditions requiring short-term pupil dilation. A Milestone in Ophthalmic Drug…
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The National Medical Products Administration (NMPA) has released the 67th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the list of drugs under evaluation. This batch includes 50 new specifications, with 11 injectables and 29 specifications undergoing modifications. Details of the 67th Batch of Reference…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced receiving clinical trial approvals for its drug candidates SHR-1819, SHR-2002, and adebrelimab (SHR-1316). SHR-1819 is now cleared to enter Phase II clinical trials for chronic sinusitis with nasal polyps, and SHR-2002 will proceed to a Phase I clinical study in advanced…
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving the green light to conduct a Phase IIa study for its ASC10 in the treatment of respiratory syncytial virus (RSV) infection. This follows the company’s previous approval from the US FDA in January 2023 to carry out a similar Phase IIa…
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US-based biotech EQRx Inc., (Nasdaq: EQRX) has disclosed in its Q4 2022 financial report a significant shift in strategy. The company, which aimed to disrupt high drug prices in the US market with cheaply sourced innovative drugs, has decided to abandon these plans. Consequently, EQRx will terminate the development of…
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China-based Shunxi Holding Group Co. Ltd has entered into a licensing deal with Australia-based firm Cartherics Pty Ltd, securing the exclusive rights to develop, manufacture, and commercialize Cartherics’ autologous CAR-T cell product, CTH-004, for the treatment of multiple solid tumors, including ovarian cancer, in Greater China. The agreement also grants…
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UK major AstraZeneca (AZ, NASDAQ: AZN) has announced that its mitogen-activated protein kinase (MEK) inhibitor, Koselugo (selumetinib), has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromatosis (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. This marks a significant advancement in…
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Angio8, a Shenzhen-based developer of vascular interventional surgical robots, has reportedly raised tens of millions of renminbi through a Series A financing round. The investment was led by Oriental Fortune Capital, with participation from Kangyu Capital, marking a significant milestone in the company’s growth and development trajectory. Commitment to First-In-Class…
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-naïve…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced encouraging results from the Phase III EXTENTORCH study, which assessed the company’s programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) in combination with chemotherapy for first-line extensive stage small cell lung cancer (ES-SCLC). The trial has successfully reached its pre-set primary…
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Tianjin, Shandong, and Hainan provinces in China have released their lists of backup suppliers following the recently completed Round 8 of the volume-based procurement (VBP) program. For the first time, the backup supplier system has been applied to drugs that are designated as being in dangerously short supply in clinics.…
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China-based Suzhou GenAssist Therapeutic Co., Ltd has announced that the US Food and Drug Administration (FDA) has accepted a pre-Investigational New Drug (pre-IND) application for the company’s first pipeline candidate, GEN6050. This in vivo base editing drug targets exon 50 skipping in the Duchenne muscular dystrophy (DMD) gene, with the…
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strategic partnership with Fudan University, aimed at leveraging their respective strengths in technology, talent, market, and industry to jointly establish a national innovation platform. This collaboration will focus on the development of new products and technologies, the strengthening of…
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Medicine with an investment of USD 100 million in 2018, has announced the receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, edralbrutinib. The designation is awarded for the…
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China-based gene therapy developer Lingyi Biotechnology Co., Ltd has reportedly raised close to RMB 100 million (USD 14.5 million) in a Series A finance round. This significant investment was co-led by Efung Capital and Huafang Asset Management, with additional participation from Transfar Science City, Sequoia China, and Huaiji Capital. The…
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will evaluate the combination of HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, with Henlius’s programmed-death 1…
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Shanghai Junshi Biosciences Co., Ltd (SHA: 688180), a China-based biotechnology firm, has announced an exclusive license and commercialization agreement with India-based Dr. Reddy’s Laboratories (BOM: 500124). The agreement focuses on the programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), marking a significant step in the global expansion of this therapeutic agent. Territorial…
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China National Pharmaceutical Group Corporation (Sinopharm, HKG: 1099) has announced a strategic partnership with Shenzhen municipality, with the aim of intensifying collaboration on high-end medical devices, innovative drugs, pharmaceutical business, and medical wellness, among other sectors. The financial details of this agreement have not been disclosed, but the partnership signals…