New stock news: Tianchen Biopharmaceutical submits application to Hong Kong Stock Exchange, developing innovative drugs for allergies and autoimmune diseases through independent research and development.

According to the disclosure by the Hong Kong Stock Exchange on August 21, Tianchen Biopharmaceutical (Suzhou) Co., Ltd. (referred to as Tianchen Biopharmaceutical) has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with Sinolink (Hong Kong) as the exclusive sponsor. According to the prospectus, Tianchen Biopharmaceutical is a clinical-stage biopharmaceutical company dedicated to innovative drug development, focusing on the independent discovery and development of biopharmaceuticals for allergic and autoimmune diseases. Tianchen Biopharmaceutical has established a comprehensive product pipeline for biological preparations targeting diseases in the fields of otolaryngology, dermatology, respirology, hematology, nephrology, and other autoimmune diseases. Based on the expected growth of the global and Chinese markets for autoimmune and allergic diseases, Tianchen Biopharmaceutical has relied and will continue to rely on (i) expertise in developing innovative drugs; (ii) two proprietary research platforms (high-affinity antibody discovery platform and bispecific antibody development platform); and (iii) strong research and development capabilities to independently develop innovative drugs for allergic and autoimmune diseases. According to the prospectus, the global market for autoimmune disease drugs is expected to grow from $138.9 billion in 2024 to $176.7 billion in 2030, with a compound annual growth rate of 4.1%. The market for autoimmune disease drugs in China has also shown rapid growth in recent years. The market size in China is expected to increase from $5.1 billion in 2024 to $19 billion in 2030, with a compound annual growth rate of 24.5%. The global market for allergic disease drugs has grown from $42.8 billion in 2018 to $68.8 billion in 2024, with a compound annual growth rate of 8.2%. It is expected to reach $111.4 billion by 2030, with a compound annual growth rate of 8.4% during that period. Tianchen Biopharmaceutical's core product LP-003 is a next-generation innovative anti-IgE antibody with novel sequence design and the best potential in its class, aimed at treating allergic diseases including allergic rhinitis (AR), chronic spontaneous urticaria (CSU), allergic asthma, and other allergic diseases. According to data from Frost & Sullivan, LP-003 is the most advanced in clinical development among next-generation anti-IgE biologics worldwide. The company's key product LP-005 is a novel targeted C5 and C3b complement bispecific antibody fusion protein with global leading potential, used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), complement-mediated kidney diseases (including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), and lupus nephritis (LN), as well as generalized myasthenia gravis (gMG), anti-MAG peripheral neuropathy (MAG-PN), and amyotrophic lateral sclerosis (ALS). Tianchen Biopharmaceutical's core product LP-003 and key product LP-005 are both in clinical development and have received IND approvals from the China-CDAP. The company has obtained IND approvals for multiple indications for LP-003 in China and/or initiated related clinical trials, including AR, CSU, allergic asthma, allergic rhinitis with nasal polyps (CRSwNP), and food allergies. Currently, Tianchen Biopharmaceutical is conducting a Phase III clinical trial of LP-003 for seasonal AR indications in China and plans to submit a BLA to the National Medical Products Administration before the third quarter of 2026. For CSU, the company is conducting a Phase II clinical trial in China comparing to omalizumab. Tianchen Biopharmaceutical expects to complete the Phase II clinical trial in the first half of 2026 and start a Phase III clinical trial. In addition, the company is conducting a Phase II clinical trial for allergic asthma and plans to start Phase II clinical trials for other allergic diseases in 2026. For LP-005, Tianchen Biopharmaceutical has obtained IND approvals for multiple indications, including PNH, complement-mediated kidney diseases (including but not limited to IgAN, C3G, and LN), and other complement-related indications. The company is currently conducting a Phase II clinical trial in China to evaluate the efficacy of LP-005 in treating PNH. In addition, the company plans to initiate a Phase II clinical trial in China for LP-005 targeting complement-mediated kidney diseases (including IgAN, C3G, and LN). Further exploration of the application of LP-005 in other complement-related diseases is expected, including but not limited to gMG, MAG-PN, and ALS. In addition to the core and key products, Tianchen Biopharmaceutical is developing the bispecific autoimmune antibody LP-00A for allergic diseases, the bispecific B cell inhibitor LP-00C for B cell-mediated autoimmune diseases, and the bispecific antibody or fusion protein complement inhibitor LP-00D optimized for specific tissues/organs and indications. Financially, for the year ended 2023, 2024, and the six months ended June 30, 2025, Tianchen Biopharmaceutical's other income and revenue were approximately RMB 2.23 million, RMB 3.07 million, RMB 1.378 million, and RMB 0.879 million, respectively; during the same periods, the company's net loss and comprehensive loss totaled approximately RMB 95.778 million, RMB 137.321 million, RMB 58.925 million, and RMB 94.208 million, respectively. According to the risks section described by Tianchen Biopharmaceutical, the company's candidate drugs face intense market competition, and competitors may discover, develop, or commercialize competitive drugs faster or more effectively, which may adversely affect the company's ability to successfully commercialize its candidate drugs.