A Large Market Size, Prominent Advantages of Core Drugs
In 2018, the global market size of oncology drugs reached USD128.1 billion, while that of autoimmune drugs, USD113.7 billion. InnoCare upholds a development strategy to explore therapies for cancer and autoimmune diseases. In other words, it engages in the therapeutic fields covering the business opportunities and synergy of the two major markets. China’s oncology drug market has undergone rapid growth. The market size is expected to reach USD48.7 billion by 2023 and climb to USD101.6 billion by 2030. Moreover, the Chinese government designated the pharmaceutical industry as a “pillar industry” of China in 2016 and endeavored to complete multiple medical reforms by 2030 (i.e. the “Healthy China 2030” Initiative). The expansion of the National Reimbursement Drug List will hopefully reduce the financial burden of tumor treatment for patients, which will further drive the increasingly growing oncology drug market. China is expected to become the world’s second largest oncology drug market after America in the next five years.
In the face of this huge market, InnoCare boasts nine drug candidates at present. Especially, the core product of Orelabrutinib is a potential, best-in-class, and irreversible BTK inhibitor with high selectivity against multiple B cell malignancies and autoimmune diseases. BTK is a proven target for the treatment of B cell malignancies. However, BTK inhibitors, that have been approved currently, are frequently reported to lead to toxic reactions, such as diarrhea, bleeding, and atrial fibrillation, which are the off-target effects of the inhibitors. Consequently, their clinical use is restricted. In contrast, the preclinical study of InnoCare revealed that Orelabrutinib is superior to ibrutinib (Imbruvica) and acalabrutinib (Calquence) in terms of inhibiting BTK. Up to now, the results of clinical trials have demonstrated that the high selectivity of Orelabrutinib can alleviate the off-target effects, resulting in excellent safety. Thanks to the excellent safety, Orelabrutinib will hopefully become a drug candidate for monotherapy and combined therapy. InnoCare is assessing the efficacy of Orelabrutinib against relapsed and refractory (r/r) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL) in registrational trials. It has achieved significant progress recently. The NDA filing against r/r CLL/SLL was submitted to the NMPA in November 2019 and accepted. And it was included by the NM in priority review and approval. The NDA filing against r/r MCL was submitted to the NMPA in March 2020 and accepted.
Additionally, the Company has two FGFR inhibitors, namely, ICP-192 (pan-FGFRi) and ICP-105 (FGFR4i), under Phase I/II clinical trials as drug candidates. Its products under R&D include six independently developed drug candidates at investigational new drug application (IND) enabling stage. Particularly, the IND of a drug candidate against pan-TRK was completed in March this year.
Outstanding and Efficient Team Execution
Operating capability is essential for a biomedicine company. A most significant indicator would be efficiency.
In terms of the expansion of enterprise size, InnoCare has grown from a team consisting of several members into a comprehensive biomedical enterprise integrating the whole processes of drug discovery, clinical drug development, production, and commercialization in the past four and a half years after incorporation. The number of R&D personnel exceeds 90. It boasts a clinical team of over 60 personnel. Its pharmaceutical manufacturing base in Guangzhou was roofed in January 2020. No doubt its overall development speed is amazing.
In regard to R&D management, since its incorporation in November 2015, InnoCare has three drug candidates under clinical trials. Another drug candidate against pan-TRK, had the IND completed in March this year. Moreover, multiple self-developed drug candidates were at the IND enabling stage. Among many drug candidates, the registrational trials of Orelabrutinib against two indications, that is, r/r CLL/SLL and MCL, has been completed. And the application for marketing has been submitted. The study on safety, tolerance, and PK/PD at Phase I Clinical trial of ICP-192 was completed. Phase II Clinical trial will be initiated soon. Phase I Clinical trial of ICP-105 is in progress. Furthermore, the Company intends to include one to three compounds every year. It is promising to have continuous and fast development.
A super-professional scientific team, huge commercialization potential of products
The R&D team of InnoCare consists of 150 members, led by Dr. Jisong Cui, founder and CEO of the Company, with over 20-year experience in the industry. In addition, InnoCare has established a Scientific Advisory Board composed of top professors and key opinion leaders (KOLs), including Dr. Yigong Shi (founder, the President of the Scientific Advisory Board, Non-Executive Director, and expert in structural biology and oncology), Dr. Zemin Zhang (Independent Non-Executive Director, expert in cancer genes, professor of Peking University, and former Director of the Bioinformatics Department, Genentech Inc.), Dr. Zhanguo Li (a world-class specialist in rheumatoid immunotherapy and former director of the Clinical Immunology Center/Rheumatism Immunology Department, Peking University People’s Hospital), and Dr. Arnold Levine (a globally recognized leader in cancer research and professor emeritus at the Institute of Advanced Study). InnoCare has developed a world-class team to achieve the common objective of promoting disruptive medical innovation in China.
Based on sufficient drug candidates and a world-class and professional scientific team, InnoCare is accelerating its R&D and commercialization. It plans to construct an independent production facility and enhance commercialization in order to support the expected launch of products. In accordance with offering data, the Company is building a production facility covering an area of 50,000 square meters in Guangzhou for commercial and large-scale production. The annual capacity will be one billion tablets. The design of the facility conforms to good manufacturing practice (GMP) standards of U.S, Europe, Japan, and China. The construction will be completed by the fourth quarter of this year. Besides, InnoCare is developing a commercialization team led by leaders with rich marketing experience in the hematology market. It intends to build up the commercialization capability by phases. The Company will seek strategic cooperation opportunities globally, establish partnerships with leading pharmaceutical companies selectively to maximize the global value of its drug candidates. It is committed to becoming a global biomedical leader developing innovative therapies for patients across the world.
Continuous support by existing shareholders and a professional cornerstone team
The listing of InnoCare is backed by Vivo Capital, Hankang Biotech Fund I, L.P, 3H Fund, and Loyal Valley Capital, as well as domestic and overseas funds, such as China Structural Reform Fund, Matthews Asia Funds, Tiger Pacific, Rock Springs. It is highly recognized by investors. Its subsequent performance in the capital market is anticipating.
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