About MABPHARM-B Company

We are a leading biomedical company in China, focusing on the development and commercialization of new drugs and biosimilar drugs to treat cancer and autoimmune diseases. We are committed to bringing high-quality and affordable innovative biopharmaceuticals to the market through an efficient R&D system and low-cost drug production capacity, and making full use of our rich R&D experience to develop a variety of therapeutic products. Our drug candidate pipeline currently includes 9 monoclonal antibody drugs and 1 strong antibody drug, 3 of which are our core products: CMAB008 (injectable infliximab): Approved for marketing by the National Drug Administration in July 2021 (Sinopharm Standard S20210025), approved for the treatment of the following indications: 1) ulcerative colitis in adults; 2) ankylosing spondylitis; 3) rheumatoid arthritis; 4) Crohn's disease in adults and children over 6; 5) fistula Crohn's disease; 6) psoriasis. Our subsidiary Taizhou Pharmaceutical's antibody drug production base in China Pharmaceutical City, Taizhou, Jiangsu, has also successfully passed the GMP compliance inspection for CMAB008 class discontinued by the Jiangsu Drug Administration. CMAB008 is also automatically included in medical insurance in accordance with health insurance regulations. CMAB008 has been discontinued for the treatment of six indications. The number of patients with these indications in China has exceeded 10 million and continues to grow, and there is huge market demand that has not been met for a long time. By the end of 2023, CMAB008 had achieved online sales in all provinces in China. Sales in 2023 increased significantly compared to 2022, with terminals covering more than 1,000 hospitals of all levels, primary care institutions, and pharmacies. At the same time, in addition to routine indications, infliximab was included in the 10th edition of the COVID-19 diagnosis and treatment plan and the fifth edition of the COVID-19 Diagnosis and Treatment Consensus for Children, and is used in the treatment of multisystem inflammatory syndrome (“MIS-C”) in children, and its status as a guideline has been further enhanced. In 2023, we held 3,142 special academic forums on CMAB008; for the welfare of low-income patients, we continued to implement relief CMAB008 drug withdrawal activities to give back to the community; as the academic and social feedback of CMAB008 discontinued drugs progressed, the market promotion of CMAB008 discontinued was significantly effective, thus providing a solid impetus for continued rapid growth in product sales. Based on high-quality innovative drugs, the company will provide affordable innovative antibody drug supply to the vast majority of Chinese patients with more economical drug supply solutions and initiatives to fully participate in China's national medical system reform; the company has also initiated cooperation with partners that have accumulated rich overseas market resources over a long period of time to rapidly expand overseas markets. Currently, it has initiated registration and expansion work in more than 30 countries and/or regions, and has completed GMP inspections in 3 countries. Among them, the GMP inspection certification of PIC/S member Brazil has been passed. CMAB007 omalizumab (omalizumab for injection): It was approved for marketing by the State Drug Administration in May 2023 (Sinopharm standard S20230030 (specification: 75 mg/bottle), Sinopharm standard S20230031 (specification: 150 mg/bottle)), approved for treatment of patients with asthma diagnosed as IgE-mediated. It is the first domestically produced novel antibody for the treatment of allergic asthma approved by the State Drug Administration. In August 2023, CMAB007 was approved by the State Drug Administration to conduct clinical trials for chronic spontaneous urticaria in adults and adolescents (12 years and above) who still have symptoms after treatment with H1 antihistamines. We have successfully initiated the phase III clinical trial of CMAB007 omexu for urticaria. As an anti-IgE monoclonal antibody, cMAb007 is expected to expand its range of indications to allergic diseases such as allergic rhinitis and food allergies. In the future, we will actively carry out various studies to rapidly expand the development and treatment application of CMAB007 in various fields of allergic diseases. During the reporting period, Taizhou Pharmaceutical entered into an exclusive commercialization cooperation agreement with Jiangxi Jimin Credible Pharmaceutical Co., Ltd. (“Jimin Credible”), which has strong sales and promotion capabilities and rich experience, for the Chinese market. In 2023, CMAB007 was included in the national negotiation catalogue as an exclusive product and successfully negotiated into the national health insurance catalogue in the fourth quarter of 2023. Up to now, CMAB007 has completed procurement and listing on 34 provincial and GPO platforms, and completed delivery two months after approval for marketing, covering many hospitals, primary care institutions and pharmacies. In 2024, as an exclusive variety included in the national health insurance catalogue, we expect CMAB007 to achieve rapid market introduction and rapid sales growth. CMAB009: CMAB009 is a recombinant anti-EGFR chimeric monoclonal antibody used in combination with Folfiri for first-line treatment of mCRC. CMAB009 is prepared using a specific expression process developed by our company, which effectively avoids glycosylation modifications that cause hypersensitivity reactions. The safety and efficacy of CMAB009 was confirmed by the results of two completed clinical trials. According to the comparison between the company's clinical trial results and the published clinical trial results of traditional anti-EGFR monoclonal antibody drugs currently on the market, cMAb009 has remarkable efficacy and safety compared to the traditional anti-EGFR monoclonal antibody drugs currently marketed to treat mCRC. The State Drug Administration accepted the marketing registration application for CMAB009 in March 2023. We have submitted the supplementary information required by the State Drug Administration. It is expected that CMAB009 will be approved for listing in the second quarter of 2024. For more details, please refer to our announcement dated March 14, 2023. The company believes that after marketing, cMAb009 will be the first domestically produced independently patented anti-EGFR monoclonal antibody drug for mCRC treatment to be marketed in the Chinese market, and is expected to provide hundreds of thousands of Chinese cancer patients with better curative efficacy and affordable bio-targeted therapy. At the same time, CMAB009's indications are also expected to expand to cancer types such as pancreatic cancer, head and neck squamous cell carcinoma, and its combined use with various small molecule drugs also has huge application space for more cancer types. The Group will accelerate the clinical and registration of CMAB009 for these indications. Taizhou Pharmaceutical has reached a CMAB009 commercial rights cooperation agreement with Jiangsu Xiansheng Zaiming. According to this, Taizhou Pharmaceutical granted Jiangsu Xiansheng Zaiming exclusive commercial rights for CMAB009 in mainland China (including but not limited to the right to manage sales, marketing and promotion of CMAB009, develop and adjust related strategies in mainland China, and obtain related benefits). For more details, please refer to the Company's announcement dated August 18, 2023. (The above products are collectively referred to as “core products”). Among our other drug candidates, CMAB015 (scuchiumab) has significant curative advantages in autoimmune diseases such as psoriasis, and has become one of the fastest growing biologics in the field of psoriasis in China. We have completed Phase I of CMAB015 and are starting Phase III clinical trials. CMAB807 (desulumab) has completed a phase III clinical trial for osteoporosis, the NDA application data is being compiled, and the clinical trial for tumor bone metastasis (CMAB807X) was approved by the National Drug Administration in January 2022 (Drug Clinical Trial Approval Notice Number: 2022LP00032). The innovative “strong antibody” drug CMAB017 has been approved by the State Drug Administration for the treatment of advanced solid tumors, including but not limited to clinical trials of colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma. Compared with EGFR antibody drugs currently on the market, CMAB017 has good efficacy and safety. We have also developed the biosimilar CMAB022 (usinumab), which has good market prospects in the fields of psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. We have strong internal drug research, production, pre-clinical and clinical development capabilities. We use leading domestic drug sales companies to promote the commercialization of drugs developed by our company through commercial cooperation. On the one hand, we give full play to the scale effect of our partners' strong sales resources accumulation and experience in specific disease fields over the years, and on the other hand, build and enhance our own unique efficient sales system from specific indication fields. We focus on the development of monoclonal antibodies. Our core R&D team members have more than 20 years of experience in this field and have presided over national research projects including 3 major “863” projects (also known as the National High-tech Research and Development Plan). We are currently using four antibody drug production lines in Taizhou. We have also completed the construction of a plant at our new R&D industrial base in Taizhou. Our new 5,000-liter GMP production line has entered trial production, process verification and GMP registration stages, and the total scale of our cellular reactors has exceeded 40,000 liters. We have a solid foundation of equipment, technology and quality in the field of antibody drug preparation, which will give us an excellent competitive advantage in future medical insurance procurement negotiations. Relying on our superior domestic antibody drug development and industrialization capabilities, we are also actively expanding and implementing the CDMO business without affecting our own product development. We believe we will be able to seize China's huge market opportunities, particularly those brought about by China's recent health-care regulatory reforms (including new health insurance measures). Our main focus of research and development is monoclonal antibody drugs for cancer and autoimmune diseases. These drugs have huge undeveloped clinical demand in China. Furthermore, with the rapid development of the Chinese pharmaceutical market, medical insurance collection that may cover biopharmaceuticals in the future and the strengthening of national health insurance negotiations will largely restructure the Chinese pharmaceutical market. We will use our advantages in advanced technology, quality and cost, and an active and flexible product cooperation model to actively participate in national health care reform, seize the opportunities brought by policy reforms, and seize the huge unmet market demand in China. We have begun global market development, successfully passed the GMP inspection certification of PIC/S member countries, and accelerated the registration and marketing of our drugs in the international market.