Category: SeaPRwire

SHENZHEN, Dec 11, 2025 – (ACN Newswire) – China Medical System Holdings Limited (the “Group” or “CMS”) is pleased to announce that on 11 December 2025, the New Drug Application (NDA) of Class 1 Innovative Drug Y-3 for Injection (proposed English generic name: Loberamisal for Injection) (“Y-3 for Injection” or the “Product”) has been accepted by National Medical Products Administration of the People’s Republic of China (NMPA). The Product is a brain cytoprotectant indicated for the treatment of acute ischemic stroke. With well-defined targets and clear mechanism of action, Y-3 for Injection is able to exert multiple therapeutic effects. As the world’s first brain cytoprotectant developed based on the important targets PSD95-nNOS and MPO, in the pathological processes of stroke, Y-3 for Injection acts on multiple key pathological processes of the ischemic cascade in ischemic stroke. Through multi-target, highly selective synergy, it is more conducive to exerting brain cytoprotective effects. The Product has an excellent therapeutic effect on ischemic stroke and the potential to prevent post-stroke depression and anxiety symptoms. Y-3 for Injection demonstrates excellent clinical data with excellent efficacy and a favorable safety profile. The results of Phase II clinical trial of the Product in China indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (40mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group, with a rate difference of 16%. The Phase III clinical trial of the Product in China was conducted by Beijing Tiantan Hospital, Capital Medical University as the leading site. It has enrolled nearly 1,000 patients with acute ischemic stroke within 48 hours of onset across approximately 40 research centers nationwide, aiming to evaluate the efficacy and safety of Y-3 for Injection in treating patients with acute ischemic stroke within 48 hours of onset. The Phase III clinical study met the primary efficacy endpoint, with patients achieving significant clinical benefits and an overall favorable safety profile. The key study results are planned to be presented at international academic conferences, and the full study will be published in international academic journals. The Central Nervous System (CNS) is one of the core advantageous fields of CMS, where a deeply integrated layout has been progressively established. The product portfolio has solidified the market foundation, including the marketed innovative drug VALTOCO (Diazepam Nasal Spray), the original brand drug Deanxit (Flupentixol and Melitracen Tablets), and the improved new drug ZUNVEYL (Benzgalantamine Gluconate Enteric-coated Tablets), which is currently under NDA review. The addition of Y-3 for Injection will further strengthen the product portfolio, generating highly efficient synergies in terms of expert networks and market resources. It is expected that if approved for marketing, Y-3 for Injection will bring a new generation of brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects to Chinese patients with ischemic stroke. Leveraging the successful commercialization experience and compliant and efficient operation system, the Group will accelerate the accessibility of innovative therapies to benefit more patients. More Information about Y-3 for Injection The pathological processes of acute ischemic stroke are highly complex and interconnected. There is an urgent clinical need for multi-target, multi-mechanism coordinated interventions to achieve more effective regulation of the complex ischemic cascade, thereby improving treatment outcomes and enhancing patients’ quality of life. Y-3 for Injection is able to uncouple PSD95-nNOS, inhibit MPO activity, and enhance the activity of α2-GABAA receptor (a subtype of GABAA receptor with antidepressant and anxiolytic effects). With this multi-target, highly selective synergistic mechanism, it is expected to achieve a technological breakthrough in the simultaneous intervention of “stroke treatment and prevention of post-stroke depression and anxiety”, making Y-3 for Injection a promising novel brain cytoprotectant with excellent efficacy and more comprehensive therapeutic effects. The results of Phase II clinical trial of Y-3 for Injection for the treatment of acute ischemic stroke were presented as an oral poster at the 10th European Stroke Organisation Conference in 2024 (ESOC 2024). It indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (20mg, 40mg, 60mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group (20mg: 67.8% vs 60.7%, 40mg: 76.7% vs 60.7%, 60mg: 70.0% vs 60.7%). Moreover, the Product showed comparable safety to placebo in acute ischemic stroke patients, exhibiting good tolerability. On 24 August 2023, the Group through its wholly-owned subsidiary entered into a Collaboration Agreement (the “Agreement”) with Neurodawn Pharmaceutical Co., Ltd. (“NeuroDawn”), a clinical needs-oriented pharmaceutical company driven by innovation and R&D. In accordance with the Agreement, the Group obtains an exclusive promotion right in mainland China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. The term of the Agreement is permanent. About Stroke According to the Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) issued by the National Health Commission, approximately 3.94 million new stroke cases occur in China each year, accounting for one-third of the global new cases[1]. Among these, ischemic stroke accounts for about 72%, with over 2.8 million new cases annually; the number of existing stroke patients in China has exceeded 28 million[1]. Data from China’s cause-of-death monitoring in 2021 shows that stroke-related deaths accounted for 23% of the national total deaths[1]. Over the past three decades, the disease burden of stroke-related disabilities in China has continued to increase[1]. Coupled with factors such as the accelerating aging of the population, the pressure of stroke prevention and control will further intensify in the future, posing enormous challenges to patients’ families and society[1]. In addition, post-stroke depression and anxiety are common complications of stroke, with incidence rates of approximately 30% and 25% respectively[2]. They can hinder the recovery of patients’ neurological functions, even increase the risk of death, and severely affect patients’ prognosis. Y-3 for Injection holds significant potential value for the long-term neurological function improvement and overall prognosis of a vast number of stroke patients, indicating broad market prospects. About CMS CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs. CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients. CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardio-cerebrovascular/ gastroenterology/ ophthalmology/ skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group. Reference 1. National Health Commission of the People’s Republic of China. Guideline for Prevention and Treatment of Cerebrovascular Disease (2024 Edition) [J]. Chinese Journal of Magnetic Resonance Imaging, 2025, 16(1): 1-8. DOI: 10.12015/issn.1674-8034.2025.01.001. 2. Chen Xinyu, Lyu Xiaohan, Li Ruina, et al. Post-Stroke Anxiety [J]. International Journal of Cerebrovascular Disease, 2022, 30(2): 129-133. DOI: 10.3760/cma.j.issn.1673-4165.2022.02.010. CMS Disclaimer and Forward-Looking Statements This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert. This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections. Media ContactBrand: China Medical System Holdings Ltd.Contact: CMS Investor RelationsEmail: ir@cms.net.cnWebsite: https://web.cms.net.cn/en/home/

SUMMIT, N.J. – December 05, 2025 – (SeaPRwire) – Leapfrog Acquisition Corporation (the “Company”) announced today the pricing of its initial public offering of 12,500,000 units at a price of $10.00 per unit. The units are expected to commence trading on December 5, 2025 on the Global Market tier of The Nasdaq Stock Market LLC under the symbol LFACU. The Company, which is led by Matthew R. Pollard, Abhay N. Pande and Kevin M. Murphy, is a special purpose acquisition company formed for the purpose of effecting a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. Each unit sold in the offering consists of one Class A ordinary share (an “ordinary share”) and one half of one redeemable warrant with a strike price of $11.50 per ordinary share exercisable within 5 years of the Company completing an initial business combination. Once the securities comprising the units begin separate trading, the ordinary shares and warrants are expected to be listed on the Global Market tier of The Nasdaq Stock Market LLC under the symbols “LFAC” and “LFACW,” respectively. BTIG, LLC is serving as the sole book-running manager of the offering. The underwriters have been granted a 45-day option to purchase up to an additional 1,875,000 units at the initial public offering price to cover over-allotments, if any. A registration statement relating to these securities was declared effective by the Securities and Exchange Commission (the “SEC”) on December 4, 2025. The offering was made only by means of a prospectus, copies of which, when available, may be obtained by contacting BTIG, LLC, 65 East 55 Street, New York, NY 10022, by emailing ProspectusDelivery@btig.com, or by visiting the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Leapfrog Acquisition Corp Leapfrog Acquisition Corp is a blank check company organized for the purpose of effecting a merger, amalgamation, share exchange, asset acquisition, share purchase, reorganization or engaging in any other similar business combination with one or more businesses or entities. The Company is led by Chief Executive Officer, Matthew R. Pollard, President and Chief Investment Officer, Abhay N. Pande and Chief Financial Officer, Kevin M. Murphy. The Company will prioritize businesses in the international energy supply chain and critical minerals sectors, including their related infrastructure in its search for attractive merger candidates. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, including with respect to the anticipated use of the proceeds of the Company’s initial public offering, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements, including those set forth in the risk factors section of the registration statement and prospectus for the Company’s initial public offering. Copies of these documents can be accessed through the SEC’s website at www.sec.gov. No assurance can be given that the offering discussed above will be completed on the terms described, or at all, or that the net proceeds of the offering will be used as indicated. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, except as required by law. Media Contact Company: Leapfrog Acquisition Corp Contact: Media Team Telephone: +1-201-379-4200 LinkedIn: https://www.linkedin.com/company/leapfrog-acquisition-corporation Email In the US: abhay@leapfrogspac.com Email In Asia: matt@leapfrogspac.com kevin@leapfrogspac.com