Huadong Medicine (000963.SZ) teams up with South Korean IMB! The pharmaceutical giant adds two more innovative self-developed drugs.

On August 15, 2024, Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary Zhongmei Huadong has signed an exclusive product licensing agreement with IMBiologics corp. of South Korea (referred to as "IMB"), obtaining exclusive rights in 37 Asian countries (excluding Japan, South Korea, and North Korea), including China, for IMB's two global innovative products in the field of autoimmunity, IMB-101 and IMB-102. This agreement includes rights for development, registration, production, and commercialization. Zhongmei Huadong will pay IMB $6 million upfront, $2 million in technology transfer milestone payments, up to a maximum of $307.5 million in development, registration, and sales milestone payments, as well as double-digit royalties on net sales. The announcement states that this transaction involves two global innovative biological formulations in the autoimmune field owned by IMB. IMB-101 is a dual-specific antibody targeting OX40L and TNF, involved in regulating inflammatory cytokines, promoting differentiation of T cells and plasma cells, as well as producing autoantibodies to maintain immune homeostasis. IMB-101 is currently undergoing Phase I clinical trials in the United States for the treatment of rheumatoid arthritis. IMB-102 is a monoclonal antibody targeting OX40L, currently in preclinical studies, with potential indications for moderate to severe atopic dermatitis and other autoimmune diseases. Aiming to address unmet needs in the autoimmune field, the introduction of these two global innovative biological formulations is significant. With good efficacy, high safety, and significant effects on severe and drug-resistant patients, biologics (including monoclonal antibodies, bispecific antibodies, etc.) have gradually become the mainstream treatment for autoimmune diseases. Data shows that in 2020, biologics accounted for over 60% of the autoimmune and allergy drug market in the United States, but only about 10% in the Chinese market, indicating substantial room for growth in the penetration of biologics in China. Additionally, due to the complexity of autoimmune diseases and their mechanisms, as well as the large number of patients, there are still many unmet clinical needs in this treatment field that need to be addressed. The two innovative biological formulations acquired by Huadong Medicine are intended to be developed for rheumatoid arthritis (RA) and atopic dermatitis (AD). Rheumatoid arthritis is an autoimmune disease characterized by erosive arthritis as the primary clinical manifestation and can occur at any age. The etiology of RA is still not clear, with the basic pathological feature being synovitis, leading to gradual destruction of joint cartilage and bones, eventually resulting in joint deformity and loss of function, as well as complications such as lung diseases, cardiovascular diseases, malignancies, fractures, and depression. Epidemiological studies show that the prevalence of RA in China is 0.42%, with an estimated total of about 5 million patients, and a male-to-female ratio of approximately 1:4. As the disease progresses, disability rates increase. RA not only reduces the physical function, quality of life, and social participation of patients but also imposes a significant economic burden on patients' families and society. Atopic dermatitis, also known as eczema, is a chronic, recurrent, inflammatory disease and a common type of skin disease in the eczema category. Due to the common association with other atopic diseases such as allergic rhinitis and asthma, it is considered a systemic disease. Atopic dermatitis is characterized by recurrent episodes, prolonged course, intense itching, and severely impacting quality of life for patients. According to the "Consensus on the Comprehensive Management of Atopic Dermatitis," the prevalence of AD in China has rapidly increased in the past 20 years, with a survey in 2014 showing a prevalence of 12.9% among urban children aged 1 to 7 years and 30.5% among infants aged 1 to 12 months. According to Frost & Sullivan data, in 2022, approximately 34.5 million minors in China were estimated to have AD. The introduction of the two innovative biopharmaceutical products IMB-101 and IMB-102 is expected to effectively meet the clinical needs of patients with autoimmune diseases and further expand Huadong Medicine's product pipeline in the autoimmune field. They will synergize with existing products to enhance the company's core competitiveness in the autoimmune field. In addition to the current indications, IMB-101 and IMB-102 also have the potential to develop treatments for other autoimmune diseases, expanding their market space in the future. IMB-101 was jointly developed by HK-InnoN and Y-Biologics (two South Korean companies) and was granted global exclusive license rights to IMB in 2020. In 2023, IMB submitted an Investigational New Drug (IND) application for IMB-101 to the Food and Drug Administration (FDA) and received approval. Preclinical data showed good efficacy and safety in animal models, and IMB-101 is currently undergoing Phase I clinical trials in the United States for the treatment of rheumatoid arthritis. Currently, there are only two global investigational products targeting the same dual targets, the other being Sanofi's SAR442970, in Phase II clinical trials intended for the treatment of hidradenitis suppurativa, minimal change disease, and focal segmental glomerulosclerosis. IMB-102 is a monoclonal antibody targeting OX40L, with potential indications for moderate to severe atopic dermatitis and other autoimmune diseases. Currently, there are only five investigational products globally targeting the same single target, with the most advanced being Sanofi's amlitelimab, in Phase III clinical trials for the treatment of moderate to severe atopic dermatitis. Aside from atopic dermatitis, Sanofi is also exploring the potential of amlitelimab in treating asthma, hidradenitis suppurativa, alopecia areata, systemic sclerosis, and other indications. With a comprehensive layout in the autoimmune field and differentiated advantages, Huadong Medicine aims to secure a leading position in the "throne" of autoimmune treatments. The autoimmune field is one of the three core treatment areas that Huadong Medicine focuses on. In recent years, the company has been strategically positioning itself in the autoimmune field, introducing leading global innovative technologies and products while continuously enhancing its own innovative research and development capabilities. The company's current products and future development plans will be closely aligned with the needs of patients in the autoimmune field, providing effective and targeted treatments to improve patient outcomes.The indications for the research products cover transplant immunity, rheumatoid arthritis, systemic lupus erythematosus, psoriasis, atopic dermatitis, seborrheic dermatitis, recurrent pericarditis, cold pyridine-related periodic syndrome and other indications, covering a wide range of diseases such as skin diseases, rheumatism, cardiovascular, respiratory, transplantation, etc. It is one of the domestic pharmaceutical companies with the most comprehensive coverage of types in the field of autoimmune diseases. Currently, the company has more than 10 biological drugs and small molecule innovative products in the field of autoimmune diseases. At the same time, the company's innovative drug research and development center has independently developed multiple early-stage projects for immune diseases with new targets and biological mechanisms, all of which are progressing smoothly.In July 2024, Huadong Medicine introduced Quanshinxin Biotechnology's QX005N product. According to the announcement, QX005N is an innovative humanized monoclonal antibody developed independently by Quanshinxin Biotechnology, targeting the human IL-4 receptor subunit (IL-4R), which plays a therapeutic role in type 2 inflammatory allergic diseases. QX005N injection is the product with the most indications for IND approval among IL-4R targeted candidate drugs in China. It has obtained IND approval for the treatment of seven conditions in adults, including severe atopic dermatitis, atopic dermatitis in adolescents aged 12-17, nodular prurigo, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, asthma, and chronic obstructive pulmonary disease. Currently, two Phase III clinical trials for severe atopic dermatitis and nodular prurigo in adults are in the process of recruiting participants. It is worth mentioning that the company's introduction of the world's first self-immune new drug injection Linacysip (ARCALYST) is also in a key stage of market launch. It is the only FDA-approved drug for the treatment of recurrent pericarditis in individuals aged 12 and above, and it is included in the list of overseas urgently needed new drugs in clinical practice in China. Applications for the market launch of Linacysip for treating cold pyrin-related periodic syndrome (CAPS) and recurrent pericarditis were accepted by the NMPA in November 2023 and March 2024, respectively, and are expected to be approved for market launch one after the other within the year. CAPS and recurrent pericarditis are rare diseases, facing significant unmet clinical treatment needs in China. In addition, Huadong Medicine has also established a platform for the research and development of topical formulations. Currently, the company has more than ten products in the field of topical formulations, covering indications such as atopic dermatitis, plaque psoriasis, seborrheic dermatitis, soft tissue injuries, bone injuries, burns, and scalds, with departments covering dermatology, orthopedics, rheumatology, etc. It has integrated capabilities in the research and development, registration, production, and commercialization of topical formulations products. As some of the aforementioned topical formulations also cover autoimmune indications, they can synergize with Huadong Medicine's self-immune products, especially in the field of psoriasis treatment. The company has already laid out biological agents such as ustekinumab injection, oral cyclosporine, topical formulation ZORYVE cream, ARQ-154 (roflumilast foam), and compound topical formulation Wynzora cream for psoriasis. These products are expected to provide more treatment options for children and adults with psoriasis, forming a golden combination for psoriasis treatment and achieving full cycle coverage for all populations. Huadong Medicine's collaboration with Quanshinxin Biotechnology on ustekinumab injection is expected to be approved within the year. Huadong Medicine stated that in the future, it will continue to prioritize clinical needs and patients, cooperate with excellent domestic and foreign companies, actively promote the research and industrialization of new drugs in development and introduction, and eventually achieve a differentiated layout and leading market competitiveness in the field of autoimmune diseases.