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| Friday, 28 January 2011, 12:00 HKT/SGT | |
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Source: CMS | |
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HONG KONG, Jan 28, 2011 - (ACN Newswire) - China Medical System Holdings Limited (SEHK:867), its subsidiary and Kangzhe Pharmaceutical Research and Development (Shenzhen) Limited (hereafter referred to as the "Applicant") held a successful roundtable meeting with the State Food and Drug Administration ("SFDA") of China. The meeting took place on 13th, October 2010, and the Applicant received a finalized minutes from the drug review centre of SFDA in late December 2010.
The main purposes of the meeting were to review the historical data of Tyroserleutide and to explain and discuss the modification of clinical trial from the trial of Tyroserleutide intravenous drop to the trial of continuous intravenous injection with portable infusion pump as well as the phase III pump study design with the SFDA reviewers. The SFDA granted this meeting based on the initiative to expedite the development of National Class I New Drugs in China.
Prior to the roundtable meeting, the registration regulation requires that the treatment group of a phase III clinical trial to contain no less than 300 samples, and the intended end point of Tyroserleutide pump phase III clinical trial was to observe the survival of the 300 cases in the treatment group. According to this regulation, the applicant predicted that the clinical trial will be completed in 2015, and the product will be approved for sale in China in 2016. However, after discussion with SFDA, and because of Tyroserleutide is indicated for serious and life-threatening diseases (e.g. the treatment of late phase of knub), and because we have already completed safety assessment of the product in the past clinical trials, the SFDA may not necessarily impose the traditional requirement of 300 subjects in the treatment group in the phase III study and as a result, the Phase III pump clinical study design of the Tyroserleutide will be simplified, 150 subjects in the treatment group will be included in the clinical trial and the clinical trial is designed to observe the inhibitory effect of Tyroserleutide on the relapse of radical operation for liver cell carcinoma. The key efficacy endpoints will be the relapse free survival (RFS), as the main indicator and overall survival (OS), as the second important indicator.
The two parties of the meeting signed in the minutes in order to express the minutes reflects the accurate ideas of both sides. This meeting set up the direction for the design of the Phase III clinical trial protocol of Tyroserleutide. This change will shorten the time of the Tyroserleutide pump phase III clinical trial and this will accelerate the marketing time of Tyroserleutide.
Lam Kong, the chairman and CEO of CMS, said that: "It was productive to discuss the phase III pump clinical trial protocol with SFDA. CMS will promptly work with Kangzhe Pharmaceutical Research and Development (Shenzhen) Limited to finalize the clinical trial protocol design, offer assistance to them in conducting the trial, and expect that the trial to begin in March 2011. Assuming the smooth running of the trial, it is expected that it will complete in one and a half year, and the marketing application for CMS024 can be submitted to SFDA in the fourth quarter of 2012. According to the "Administration Regulations on Special Approval of New Drug Registration" issued in 2009, in order to expedite the development of new drug research in China, the registration of CMS024 has been in the special approval channel as it is a self-innovation National Class I New Drug. The special approval channel includes setting up separate dossier in SFDA and communicating with SFDA through the roundtable meeting to discuss the clinical trial protocol and any substantial change of the trial during the course of the trial. If the whole process goes smoothly, based on our expectation, CMS024 will be approved 3 years ahead of our original plan. Since we hold the patent for this potential National Class I New Drug and the indication of CMS024 is liver cancer (the incidence of liver cancer in China accounts for 50% of the world), plus our strong promotional ability through our sales, promotional and marketing network, we believe that CMS024 will contribute greatly to the business of the company after the year of 2013 if it is successfully launched into market."
About Tyroserleutide for Injection ("CMS024")
Tyroseleutide for injection (Tyroseleutide, also called CMS024) is a tripeptide compound with low molecular weight, which indicated for the treatment of primary liver carcinoma. After development for about 10 years, during the period from October 2003 to April 2005, Tyroseleutide completed phase I, phase IIa and phase IIb clinical trials successively, all of which were conducted by intravenous drop infusion. The phase I clinical trial results showed that tyroseleutide is safe and tolerated, and the phase IIb clinical trials results indicated that CMS024 can prolong patients' survival periods, with mild side effects and toxicity. The Kaplan-Meier Survival Curves shows that patients who received medium and high doses had statistically (P=0.0004<0.05) longer survival periods compared to those receiving lower doses. On 9 June 2005, we submitted a new-drug application for CMS024 to the SFDA for marketing approval based on the phase IIb clinical trial results, and at the end of 2007, we received an assessment notice from the SFDA, in which the SFDA requested us to further enlarge the patient sample size of the treatment group in the next clinical trial in order to provide better proof of the drug's clinical efficacy.
Tyroseleutide was developed by Kangzhe Pharmaceutical Research and Development(Shenzhen) Limited (hereinafter called Kangzhe R&D), and we acquired the Chinese patents, new drug interest and the production, marketing and sales rights of it from Kangzhe R&D by a scheme of arrangement, upon which we have paid US$3.1million, and we have appointed that we will pay Kangzhe R&D a royalty fee representing 13% of the quarterly sales revenue generated by us in respect of the sale of Tyroseleutide(CMS024) when it is successfully launched. After obtain the product rights, we have appointed Kangzhe R&D to carry out further research and development related to CMS024. In the further research, including the coming phase III pump clinical trial, no further R&D fee or any other consideration is payable to Kangzhe R&D.
We have been granted 3 invention patents to protect Tyroseleutide, of which one protects compound, pharmaceutical composition and the usage of Tyroseleutide, others protect the preparation technology and genetic testing technology of Tyroseleutide's curative effect. The mechanism study on Tyroseleutide was financially supported by the National High-Technology R&D Programme in China (The National 863 project) in July 2004.
About Tyroserleutide clinical trial conducted by continuous intravenous injection with portable infusion pump
After completion of the phase IIb clinical trial with intravenous drop infusion, in order to improve the quality of life of the patients and the patient's treatment compliance and tolerance, we began to explore the use of portable infusion pump to administrate CMS024 to patients in need for 5 days (with next course of treatment in 3-4 weeks interval), at the same time we also changed our target patients to those who has undergone tumor radical resection instead of patients with unresectable liver cancer. During the period from June 2006 to March 2007, CMS024 completed phase I clinical trial using infusion pump. The trial result showed that it is safe and tolerated to administrate CMS024 to patients by continuous intravenous injection with portable infusion pump. We conducted a randomized, double-blind, placebo-controlled, multi-center phase II clinical trial from December 2007 to May 2010, where the dosage of 6mg/d CMS024 group was shown to be vastly superior to other dosage group in prolonging 6 months of relapse free survival (RFS) and the overall survival (OS) of the patients targeted. Moreover, little side effect and good tolerance had been observed in the phase II clinical trial in which CMS024 is injected by continuous intravenous injection with portable infusion pump.
Based on the above phase I and phase II pump explorative clinical trial results, we will conduct an expanded phase III clinical trial (phase III)，which will use continuous intravenous injection with portable infusion pump.
About "Administration Regulations on Special Approval of New Drug Registration"
To encourage research and development of new drug, SFDA established the "Administration Regulations on Special Approval of New Drug Registration" based on "Provisions for Drug Registration" in January 2009. According to the regulation, Tyroserleutide and its injection preparation, as a chemical raw materials and related preparations which has not obtained domestic or overseas marketing approval, meet the conditions of special approval of new drug registration and has been included is the special approval channel. According to the regulation, the new drugs which are included in the special approval channel will be filed separately in SFDA. The Drug Review Centre of SFDA should put in place procedures and mechanism to maintain communication and discuss the related technology issues with the Applicant. At the same time, according to the related regulations of "Provisions for Drug Registration", if the application of registration is classified as special approval channel, the processing time and general procedures for SFDA approval to conduct a clinical trial and manufacture should be less. In addition, the working mechanism of filing separately and communicating with applicant can ensure the processing time of registration approval.
* Risk Warning: As a National Class I New Drug, the phase III pump clinical trial of Tyroserleutide may last longer than the Company's expectation or the processing time of SFDA may go beyond the regulated time that results in delay of marketing approval for Tyroserleutide. Or the failure of phase III pump clinical test for Tyroserleutide will result in the failure of launch.
Contact:
China Medical Systems
Gaby Yu
Investor & Media Relations Specialist
Tel: +86 755 82416868-153
Email: gaby.yu@cms.net.cn
Topic: Research and development
Source: CMS
Sectors: BioTech
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