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Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection
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Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its Olinvyk (oliceridine; TRV130) injection. The approved indication is for adult patients requiring management of acute pain severe enough to necessitate…
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Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
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China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC)…
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China’s NHC Releases Draft Guidelines for Somatic Cell Clinical Research, Seeks Public Input
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The National Health Commission (NHC) has released the “Somatic Cell Clinical Research Guidelines (draft proposal)” and is soliciting public feedback until May 24, 2023. These guidelines are designed to provide direction for companies and institutions engaged in clinical trials that do not seek formal market approval, which would otherwise necessitate…
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Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
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China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed…
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Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for APP13007 (GPN00833), a modified hormone nano suspension eye drop co-developed with Taiwan-based Formosa Pharmaceuticals Inc., (TPE: 6838). The drug is in development as an…
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Neuro3 Therapeutics Secures Exclusive License Deal with Lundbeck for KCNQ2 Activator Programs
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Neuro3 Therapeutics (Neuro3), a biotechnology company specializing in central nervous system (CNS) diseases with operations in Suzhou, China, and the US, has announced the signing of an exclusive license and option agreement with Denmark-based Lundbeck (OTCMKTS: HLUBF). This deal grants Neuro3 a global license to the intellectual property encompassing two…
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Organon Reports Q1 2023 Revenue Growth, Highlights Women’s Health and Biosimilars Progress
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Organon (NYSE: OGN) has released its financial report for the first quarter of 2023, announcing a 3% year-on-year (YOY) increase in revenues, excluding foreign exchange effects, amounting to USD 1.54 billion. This growth was driven by a 3% increase in Women’s Health revenues, a 20% increase in Biosimilars, and a…
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US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi
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China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has…
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Acorda Therapeutics Strikes Deal with Hangzhou Chance for Inbrija Distribution in China
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US-based Acorda Therapeutics Inc., (Nasdaq: ACOR) has announced a distribution and supply agreement with Hangzhou Chance Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company. This deal will facilitate the supply of Inbrija (levodopa inhalation powder) to the mainland China market, where it will be used as an intermittent treatment for episodic…
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RemeGen Ltd Receives Approval for Phase I Clinical Study of RC198 in Solid Tumors
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RemeGen Ltd (HKG: 9995) has announced that it has received approval from the Human Research Ethics Committees of Australia to conduct a Phase I clinical study for its investigational drug RC198. The study will focus on patients with locally advanced unresectable or metastatic solid tumors. RC198: An Fc Fusion Protein…
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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…
