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Grand Pharmaceutical Group Completes Enrollment in Phase III Study for Ryaltris Nasal Spray
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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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Alphamab Oncology and CSPC Pharma Get Green Light for KN026 Phase III Study in Breast Cancer
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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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Eyenovia, Inc. Receives FDA Approval for Mydcombi, a First-of-Its-Kind Ophthalmic Spray
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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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NMPA Releases 67th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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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 Advances SHR-1819, SHR-2002, and Adebrelimab into New Clinical Trials
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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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Ascletis Pharma Receives Approval for Phase IIa Study of ASC10 for RSV Infection
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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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EQRx Inc. Abandons Plans for Low-Cost Drugs, Terminates Development of Three China-Sourced Products
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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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Shunxi Holding Group Secures Licensing Deal for Cartherics’ CTH-004 in Greater China
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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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AstraZeneca’s MEK Inhibitor Koselugo Approved in China for Pediatric NF1-Related PN
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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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Shenzhen’s Angio8 Secures Tens of Millions in Series A Financing for Surgical Robot Development
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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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BeiGene’s Brukinsa Receives NMPA Approval for Expanded Use in Leukemia and Lymphoma
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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’ Tuoyi Shows Promise in Phase III Study for ES-SCLC
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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 Announce VBP Backup Suppliers for Round 8
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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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Suzhou GenAssist’s GEN6050 Receives US FDA Pre-IND Acceptance for Duchenne Muscular Dystrophy Treatment
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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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Sinopharm Partners with Fudan University to Establish National Innovation Platform
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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’s Edralbrutinib Earns Orphan Drug Designation for NMOSD from US FDA
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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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Lingyi Biotechnology Secures RMB 100 Million in Series A Funding for Gene Therapy Pipeline
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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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Henlius Biotech’s HLX26 and HaiSiZhuang Combo for NSCLC Gets NMPA Phase II Approval
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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 Inks Exclusive License Deal with Dr. Reddy’s Laboratories for Tuoyi
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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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Sinopharm Partners with Shenzhen to Boost High-End Medical Device and Pharmaceutical Innovation
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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…
