CTTQ Pharma is pleased to announce that the “Anlotinib Hydrochloride Capsules” (brand name “FOCUS V®”), which is a new Chemicals Category 1 drug of antitumor and is self-developed by CTTQ Pharma, has obtained the approval for drug registration granted by the China Food and Drug Administration of the People’s Republic of China. The approval marked the official launch of the “Anlotinib Hydrochloride Capsules”, a new innovator drug for oncological treatment that draws attention in China.

 

Anlotinib is a new small molecule tyrosine kinase inhibitor of multi-targets, which acts effectively on targets such as VEGFR, PDGFR, FGFR and c-Kit. It has double actions that can resist new angiogenesis and inhibit tumor growth. Proven by clinical trials, FOCUS V® is currently the only single-drug effective oral preparation among the advanced non-small cell lung cancer (“NSCLC”) anti-angiogenic targeted drugs with less adverse reactions and satisfactory drug tolerance of patients. FOCUS V® may become a standard drug of third-line treatment for advanced NSCLC.

 

In recent years, with the development of NSCLC first-line and second-line treatment drugs, treatment for advanced NSCLC patients has been improved. Yet, for patients who suffer from failure of the first-line and second-line treatments, the current third-line treatment is insufficient and chaotic, and those patients are found in the dilemma of lacking available drugs. Under such circumstances, the launch of FOCUS V® can provide advanced NSCLC patients with an effective new treatment.

 

 Not only did the clinical trial results prove that Anlotinib has therapeutic effect on NSCLC, but also soft tissue sarcoma, ovarian cancer and other cancers. The Group is actively conducting multi-center clinical trials in the United States and other countries. The phase IIb clinical study on treatment for soft tissue sarcoma with Anlotinib was verbally reported on the American Society of Clinical Oncology (ASCO) Annual Meeting, which indicated the recognition of such innovator drug within the international medical community.

 

The approval for FOCUS V® is a milestone in the development history of the Group. Anlotinib is the first innovative small molecule drug developed by the Group in accordance with international research and development procedures and standards and the anticancer drug of the Group with the heaviest investment so far. The successful launch of FOCUS V® marks a determined step for the strategic change of the Group from “combination of generic and innovator” to “combination of innovator and generic”, and an important breakthrough of the Group entering the area of oncological treatment.