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 signed a License, Collaboration and Distribution Agreement (the “License Agreement”) with Midatech Pharma PLC (“Midatech Pharma”) dated 29 January 2019. According to the License Agreement, the Group through its wholly-owned subsidiary will gain exclusive, perpetual, transferable, sub-licensable rights to develop and commercialize Midatech Pharma’s current products mainly including MTD201, MTX110 (subject to receipt of consent from Novartis Pharma AG) and any new pharmaceutical products or line extension the intellectual property rights and other rights of which Midatech Pharma controls and which Midatech Pharma or its affiliates have given a codename within three years of the effective date of the License Agreement (the “Products”, MTD201 and MTX110, the “Main Products”) in China (including Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan) and certain Southeast Asian countries selected by CMS (including Singapore, Philippines, Malaysia and other countries. At the same time, the Group through its wholly-owned subsidiary signed a Subscription Agreement with Midatech Pharma pursuant to which the Group has agreed to make an equity investment in Midatech Pharma.
INTRODUCTION TO MTD201 AND MTX110, MAIN PRODUCTS OF Midatech Pharma
The main product of Midatech Pharma, MTD201, has completed bioequivalence studies and is planned to conduct pivotal clinical studies. MTD201 is an intramuscular Q-Sphera? polymer microsphere formulation of octreotide that releases drug over an extended period to enable a monthly injection regimen. MTD201 is being developed for the treatment of acromegaly and management of neuroendocrine cancer. Octreotide is a somatostatin analogue recommended to manage conditions associated with excessive growth hormone secretion, and hormonal tumours by guidelines in various countries. MTD201 is Midatech Pharma’s lead pipeline candidate. The clinical equivalence study between MTD201 and Sandostatin LAR (Octreotide Acetate Injection, SLAR) has been completed in Europe. Currently a follow-on pivotal registration study is being planned. Various production process patents of MTD201 have been granted in China, which are valid up to 2032.
Another major product of Midatech Pharma MTX110 is ongoing Phase I/II clinical trials. MTX110 takes the known active histone deacetylase inhibitor (HDACi) panobinostat, and solubilizes it into liquid form using Midatech Pharma’s nano-inclusion technology. MTX110 is mainly being developed for the treatment of diffuse intrinsic pontine glioma (DIPG). Panobinostat oral solid formulation has been approved by FDA for the treatment of multiple myeloma in February 2015. MTX110 increases available routes of administration for panobinosta, which is essential because the drug does not cross the blood-brain barrier effectively when given orally. MTX110 can therefore be delivered directly to a patient’s tumor via convection enhanced delivery (CED), bypassing the blood-brain barrier.
About Midatech Pharma
Midatech Pharma is an international specialty pharmaceutical company focused on the research and development of a pipeline of medicines for oncology and immunotherapy. Midatech Pharma’s R&D activities focus on three innovative platform technologies to deliver drugs at the “right time, right place”: gold nanoparticles (GNPs) to enable targeted delivery; Q-Sphera polymer microspheres to enable sustained release (SR) delivery; and Nano Inclusion (NI) to provide local delivery of therapeutics, initially to the brain. The shares of Midatech Pharma are listed on London’s Alternative Investment Market.
This cooperation will further enrich the Group’s patented innovative products pipeline and the Company believes that the Products will have broad market prospects after being commercialized in the Territory. At the same time, Midatech Pharma is focusing on the research and development of a pipeline of medicines for oncology and immunotherapy, and it has three innovative technology platforms – Q-Sphera?, MidaSolve? and MidaCore?. The Group contributes to Midatech Pharma’s professional research through participating in the equity investment in it and shares the extraordinary achievements transformed by its technology platforms.