Dr. Fang Jianmin, CEO of RemeGen Co., Ltd. (688331.SH/09995.HK) delivered a keynote speech at the 42nd J.P. Morgan Annual Healthcare Conference in San Francisco, USA, at 11 a.m.on January 9, US time. With the theme of “Focusing on Innovative Biologicals to Meet Major Clinical Needs”, Dr. Fang shared how the company successfully turned itself from a Biotech to a Biopharma with global pharmaceutical industry experts and investment elites.

As the largest and most informative medical and healthcare investment event in the world, the JPM conference brings together multinational companies, emerging pharmaceutical companies, entrepreneurial leaders and investment elites, and is known as the industry benchmark in the global pharmaceutical investment field.

In his speech, Dr. Fang stated that RemeGen has laid out three major fields of autoimmunity, oncology, and ophthalmology, possesses three core technology platforms: the antibody & fusion protein platform, the antibody drug conjugate (ADC) platform, and the Hinge-insersion bispecific antibody (HiBody) platform, and holds two marketed products, namely, Telitacicept and Disitamab vedotin, and has established R&D and clinical teams in China, the US, and Australia, which span from early stage of research, clinical development, to commercialization, production, and sales, gradually realizing the stunning transformation from Biotech to Biopharma.

Dr. Fang introduced in detail the latest progress of two core products. He said that Telitacicept, as the first-in-class fusion protein medicine independently developed by RemeGen, has obtained encouraging results in clinical studies for systemic lupus erythematosus indication that was marketed in China, as well as in multiple indications such as rheumatoid arthritis, IgA nephritis, Sjogren’s syndrome, and myasthenia gravis. At present, multiple phase 3 clinical trials of Telitacicept are progressing smoothly, it is expected to become a pioneer blockbuster drug in the global B cell-mediated autoimmunity track. ADC is the track that the current pharmaceutical giants in the world are seizing. Dr. Fang said that relevant research of Disitamab vedotin in the treatment of HER2-expressing second-line urothelial cancer has been published in JCO, a top international journal of oncology. It proved once again the leading position of this drug in the field of UC treatment. As the first domestic ADC independently developed by RemeGen, Disitamab vedotin has significant differentiated advantages. RemeGen will continue to advance its research on frontline treatments for urothelial cancer, gastric cancer, breast cancer and other indications. At present, the global clinical progress of Disitamab vedotin is going smoothly, and clinical research led by partners is progressing smoothly.

In addition to Disitamab vedotin, RemeGen’s new ADC drugs have shown promising results in clinical studies when combined with PD-1 inhibitors and chemotherapy. These studies have been conducted in patients with gastric cancer, bladder cancer, breast cancer and other solid tumors, highlighting the potential of ADC combination therapy in treating a wide range of cancers. With its self-developed three professional technology platforms, the company’s product pipeline also has more than ten molecules in different stages of development, targeting several indications with obvious differentiated competitiveness.

Dr. Fang said that RemeGen’s drugs under development continue to make breakthroughs and have great potential for commercialization. On the production side, a production system that complies with international GMP standards has been established, which can fully meet the current clinical and commercial production needs of approved drugs. It is expected that the total production capacity of raw liquid will be expanded to more than 80,000 liters in 2025, which can fully support the global commercial production of products. In terms of sales, a marketing team of nearly 2000 people has been established. Both core products are already marketed, have been included in medical insurance, and have entered more than 600 grade-A tertiary hospitals or general hospitals in core prefecture-level cities, with significant sales volume.

Regarding the development of RemeGen in the next few years, Dr. Fang mainly talked about the following four points: first, promote the global development of multiple indications of Telitacicept at full speed and build its leadership position in B cell-mediated autoimmunity drugs. Second, accelerate the domestic clinical trials of Disitamab vedotin, support the global development of multiple indications, and build differentiated competitive advantages. Third, improve ADC platform technology and develop a new generation of FIC/BIC ADC drugs. Fourth, expand domestic sales and strengthen global cooperation to drive the development of commercialization in two aspects.