CMS entered into a framework asset transfer agreement for NRL-1 etc.

Company News

China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Group through its wholly-owned subsidiary (the “CMS Subsidiary”) entered into a framework asset transfer agreement (the “Agreement”) with A&B (HK) Company Limited (“A&B”) relating to the pharmaceutical preparation, formulation, dosage form, or delivery vehicle, containing or comprising NRL-1 etc. and/or line extensions (collectively, the “Products”), A&B is a company wholly-owned by Mr. Lam Kong, a controlling shareholder (as such term is defined in the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”)) of the Company. According to the Agreement, the Group has agreed to acquire all assets related to the products (the “Assets”) in China (including Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan) (the “Territory”) from A&B, and assumed all rights and obligations in respect of the Assets (the “Transaction”).

A&B obtained the Assets from an entity which in turn obtained the Assets from Neurelis, Inc. (“Neurelis”). The Assets include but without limitation the marketing authorization, manufacture rights, intellectual property and all commercial information, medical information, know-how and records related to the Products in and for the Territory. In addition, pursuant to the Agreement, the Group also acquired all the necessary licenses related to, among other things, the commercialization of the Products under the Agreement.

NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via a nasal formulation in a spray, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of increased seizure activity, also known as acute repetitive or cluster seizures.

NRL-1 has completed the registration data required for New Drug Application (NDA) submission to the US Food and Drug Administration (FDA). In China, NRL-1 is classified as a modified new drug for class 2 according to Chemical Drug Registration Classification. The Company will apply for marketing authorization with submitting overseas clinical research data (including PK comparison reports in Asian and other ethnic population) to the China National Drug Administration (CNDA) for exemption from clinical trial according to Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Pharmaceutical Medical Devices issued by General Office of State Council of China. If exemption from clinical research is approved, NRL-1 will be approved by CNDA in China as soon as possible after it is approved by FDA in America.

NRL-1 will not only provide convenient, effective and safe first-aid treatment to rescue cluster seizures, but also greatly improve the quality of life of patients and their caregivers and reduce their huge economic burden. It could be foreseen that once this product is approved in China, it will certainly become a long-term prepared and essential medicine for patients with acute repetitive seizures, and the market prospects are promising.

Neurelis is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. It leverages its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates, such as NRL-1 for the treatment of acute repetitive or cluster seizures, to address significant unmet medical needs.

This cooperation will further enrich the Group’s patented innovative pipeline products and the Group believes that the Products will have broad market prospects after being commercialized in the Territory.