InnoCare Pharma Submits IPO Application to HKEX, with Orelabrutinib NDA Filing Imminent

Beijing InnoCare Pharma Tech Co., Ltd. (hereinafter referred to as “InnoCare”) filed its IPO prospectus with the Hong Kong Stock Exchange today. InnoCare is a clinical-stage biopharmaceutical company that leverages a combination of in-house R&D, external licensing, and international collaborations to rapidly develop multiple drug candidates designed to modulate the immune system for the treatment of autoimmune diseases and cancers.

InnoCare focuses on autoimmune diseases and oncology, aiming to address the significant unmet medical needs of patients, particularly those in China.

Autoimmune diseases occur when a patient’s immune system attacks their own healthy tissues. Conventional therapies typically focus on suppressing immune system activity. InnoCare is actively developing highly differentiated immunosuppressive drugs with novel mechanisms of action for the treatment of autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus.

In the field of oncology, InnoCare primarily focuses on liver cancer and gastric cancer. Over the past two decades, the incidence of hepatocellular carcinoma (HCC) has doubled, while the five-year survival rate remains below 12%. There are 700,000 new HCC cases globally each year, with more than half occurring in China. Currently, there are no highly effective treatments available for HCC on the market. The only approved first-line therapy is sorafenib, a multi-kinase targeted drug that is expensive and associated with significant side effects. There is an urgent need to develop new drugs with high specificity, safety, and efficacy. Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths, accounting for 7% of all cancer cases and 9% of cancer-related fatalities. It is most prevalent in China and East Asia, with an incidence rate in men twice that in women. Chemotherapy and antibody-based targeted therapies are currently the main treatment options besides surgery and radiotherapy.

Within less than four years since its establishment, InnoCare’s R&D team has developed nine drug candidates with the potential to become Best-in-Class or First-in-Class therapies, including one candidate in registrational trials, two in Phase I/II clinical trials, and six in the IND-enabling stage.

In the drug pipeline diagram of the prospectus, InnoCare disclosed the trial stages of five drugs.

Orelabrutinib (ICP-022): Currently undergoing registrational clinical trials in China and the United States, orelabrutinib is a potential best-in-class, highly selective, and irreversible BTK inhibitor for the treatment of various B-cell malignancies and autoimmune diseases. Multiple trials targeting chronic lymphocytic leukemia, small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma, central nervous system lymphoma, diffuse large B-cell lymphoma, Waldenström’s macroglobulinemia, and systemic lupus erythematosus are being conducted in both China and the United States. The two most advanced registrational trials are evaluating the efficacy of orelabrutinib for two indications: relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and relapsed/refractory mantle cell lymphoma (MCL). A New Drug Application is expected to be submitted to the National Medical Products Administration (NMPA) of China by the end of 2019.

In addition to various lymphomas, InnoCare also plans to evaluate the potential of orelabrutinib as a therapy for autoimmune diseases. A Phase Ib/IIa trial of orelabrutinib in combination with standard-of-care therapy for systemic lupus erythematosus (SLE) will be initiated in China in the fourth quarter of 2019.

ICP-192: A potential best-in-class, potent, and selective pan-FGFR inhibitor for the treatment of various solid tumors. ICP-192 is one of the first-in-class pan-FGFR inhibitors currently in clinical development in China. Initial focused extension studies are being conducted in patients with cholangiocarcinoma harboring FGFR2 fusions and in patients with urothelial carcinoma harboring FGFR2/3 gene mutations. Meanwhile, further data collection is planned to evaluate whether ICP-192 can serve as a potential therapeutic option in combination with other agents (e.g., immune checkpoint inhibitors) for the treatment of patients with FGFR mutations.

ICP-105: A potential first-in-class, potent, and highly selective FGFR4 inhibitor, primarily indicated for the treatment of advanced hepatocellular carcinoma (HCC) with FGFR4 pathway hyperactivation. Phase IIa studies are currently planned to evaluate the safety and efficacy of ICP-105 in patients with HCC exhibiting FGFR4 pathway hyperactivation. Additionally, plans are underway to explore the combination of ICP-105 with immune checkpoint inhibitors for the treatment of advanced HCC with FGFR4 pathway hyperactivation.

In addition, InnoCare has six candidate drugs in the IND-enabling stage, two of which were disclosed in the prospectus: ICP-723 and ICP-330. ICP-723 is a second-generation pan-tropomyosin receptor kinase (pan-TRK) small-molecule inhibitor indicated for patients with neurotrophic tyrosine kinase (NTRK)-positive tumors across various tumor types, as well as for patients who have developed resistance to first-generation TRK inhibitors due to resistance-conferring TRK gene mutations. ICP-330 is a TYK2 small-molecule inhibitor indicated for the treatment of various T cell-mediated autoimmune diseases, such as psoriasis, inflammatory bowel disease, and systemic lupus erythematosus.

InnoCare was established in November 2015. In January 2016, the company initiated its Series A and B1 financing rounds, raising a total of $3.8 million. In December 2017, orelabrutinib received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) to commence clinical trials. In January 2018, InnoCare completed a $55 million financing round, led by Vivo Capital, with participation from existing shareholders such as Shanghai CCB Capital. In December 2018, the company closed a $180.5 million Series D financing round, with investors including Lyra Capital, CCB Capital, and Vivo Capital.

Currently, InnoCare remains in the R&D stage and has not generated any commercial revenue. Overall R&D investment is substantial, with R&D expenses reaching RMB 150 million in 2018 and RMB 94.83 million in the first half of 2019. However, if orelabrutinib is launched and marketed in 2020, it will create a significant new source of revenue in the future.

Following its listing, InnoCare will utilize the funds raised for facility construction, establishment of a sales team, and continued investment in research and development. InnoCare is currently constructing a 50,000-square-meter production facility in Guangzhou for large-scale commercial manufacturing, with an annual capacity of one billion tablets. The facility is expected to be completed and become operational in the fourth quarter of 2020. It is designed in compliance with Good Manufacturing Practice (GMP) regulations in the United States, Europe, Japan, and China. As orelabrutinib is scheduled for imminent market launch, InnoCare has established a sales and marketing leadership team and is expanding its commercialization workforce, with plans to build a sales team of 80 to 90 members.

In the new drug sector, in addition to InnoCare filing its prospectus today, Ascentage Pharma-B (06855.HK) has also commenced its IPO subscription period from October 16 to 21. The company plans a global offering of approximately 12.1809 million shares, including 1.2182 million shares for the Hong Kong public offering and 10.9627 million shares for the international placement. The offer price is set at HK$32.20–HK$34.20 per share, with listing expected on October 28.