Beijing, China, 1 July 2022 - InnoCare (HKEX: 09969), a leading biopharmaceutical company, announced today that InnoCare’s pharmaceutical production facility in Guangzhou (hereinafter referred to as the “Guangzhou Base”) has been granted an official approval for the commercial production of Orelabrutinib tablets with immediate effect on 30 June 2022. The approval marked the embarking of InnoCare’s self-production, thereby providing patients with high-quality products and services.
Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, “The approval of InnoCare’s Guangzhou Base for commercial production is a significant step for InnoCare to build a comprehensive industrial chain. High-quality production can improve the availability of international high-quality innovative drugs for the treatmet of patients. InnoCare always adheres to the core concept of “Science-driven Innovation for Patients’s Needs”, with a view to better catering for the needs of patients for high-quality innovative drugs.”
Drug quality is crucial for innovative pharmaceutical companies. InnoCare’s Guangzhou Base always regards quality management as the top priority. With international quality standards as the benchmark, Guangzhou Base has adopted international advanced production technology and equipment, and established a quality management system with reference to the GMP standards of China, Japan, the United States and the European Union. In April this year, InnoCare’s Guangzhou Base successfully passed the audit carried out by the Qualified Person (“QP”) of EU, indicating that InnoCare’s Guangzhou Base is enabled to provide clinical drugs for the European market.
Improving the solubility of poorly soluble drugs has become a focus and challenge in the research and development of innovative drug formulation. InnoCare’s Guangzhou Base has built a technical platform to solve such problems, including the establishment of international advanced production lines of spray-dried solid dispersion, hot melt extrusion solid dispersion and solid dosage forms, and equipped with three major technology platforms, namely the solubilization preparation technology for poorly soluble drugs, the modified release drug delivery system and the targeted drug delivery technology, thereby solving the common problems faced by the industry. InnoCare’s solid dispersion technology is the core technology in the solubilization process, which can accelerate the solubility and dissolution rate of poorly soluble drugs, thus improving the bioavailability of drugs and better catering for the needs of the development and production of new drugs.
InnoCare’s Guangzhou Base is located at Sino-Singapore Guangzhou Knowledge City, which is a major project for the biomedical industry introduced by Guangzhou Development Zone. The construction of InnoCare’s Guangzhou Base has been progressing rapidly in a safe and efficient way. In the middle of 2019, the construction of InnoCare’s Guangzhou Base kicked off with the commencement of its foundation work. The topping of the superstructure was completed in January 2020 and the first phase of the project was completed at the end of 2020, leading to the approval for production today.
Sino-Singapore Guangzhou Knowledge City is one of the major innovation platforms for the construction of the Guangdong-Hong Kong-Macao Greater Bay Area. It is a national-level bilateral cooperation project and an international knowledge innovation platform jointly built by China and Singapore. Huangpu District and Guangzhou Development Zone, where Sino-Singapore Guangzhou Knowledge City is located, are currently developed into a world-class advanced manufacturing cluster, with a focus on the development of strategic emerging industries including biomedicine industry, thus facilitating the industry to enter the high end of the global value chain.
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
On Dec. 25 2020, orelabrutinib received conditional approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients.
In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies.
Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).
In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.
InnoCare (HKEX: 09969) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.