About MABPHARM-B Company

We are a leading biomedical company in China, focusing on the development and industrialization 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 pipeline currently includes 9 monoclonal antibody drugs and 1 strong antibody drug. Of these, 3 drugs that have been approved for marketing are our core products: CMAB009 Enritol (cetuximab beta injection): CMAB009 is a recombinant anti-epidermal growth factor receptor (“EGFR”) chimeric monoclonal antibody, which was approved for marketing by the State Drug Administration in June 2024 (Sinopharm Standard S20240025), and approved for first-line treatment of RAS/BRAF wild type metastatic colorectal cancer (“mCRC”) in combination with FOLFIRI program. CMAB009 was developed and prepared using the company's specific Chinese hamster ovary cell (CHO) expression process technology for which the company has obtained an international PCT patent (PCT Patent No.: PCT/CN2016/070024), which has achieved remarkable curative efficacy and obvious safety advantages, and has been fully confirmed in the results of two completed clinical trials. In August 2023, Taizhou Pharmaceutical and Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd. (“Jiangsu Xiansheng Zaiming”) reached a CMAB009 commercial rights cooperation agreement. According to this, Taizhou Pharmaceutical granted Jiangsu Xiansheng Zaiming exclusive commercial rights for CMAB009 Enrito in mainland China (including but not limited to the formulation and adjustment of sales management, marketing and promotion of CMAB009 Enritol in mainland China, and the right to obtain related benefits). CMAB009 is the company's third drug approved for marketing. It is also the first domestically produced innovative new anti-EGFR monoclonal antibody with independent intellectual property rights for first-line treatment of mCRC approved by the State Drug Administration. The indications for CMAB009 enritol 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 room for development and application in more indications such as non-small cell lung cancer. The Group will expedite the clinical and registration of CMAB009 Enritol for these indications. For further details of the approval by the State Drug Administration, please refer to our announcement dated June 25, 2024. According to the “2022 Burden of Malignant Tumors in China” published by the National Cancer Center, colorectal cancer (also known as colorectal cancer) has a remarkable incidence rate in China, adding about 0.5 million new patients each year, ranking second in the incidence of malignant tumors. In more developed regions, the incidence of colorectal cancer may even exceed that of hepatitis B. Chinese patients have always relied heavily on imported anti-EGFR antibody drugs; mainstream imported drugs are expensive, and more than 2% of people may have severe allergic reactions in clinical studies, so there are black box warnings for serious adverse reactions on the front pages of instructions approved by China and the US. As the first self-developed new EGFR target antibody drug to be marketed in China in nearly 20 years, CMAB009 Enritol has remarkable clinical effects. Its safety without a black frame warning is better than mainstream imported drugs with a black frame warning for serious adverse reactions, and it will surely be widely welcomed by doctors and patients. We have completed the initial delivery and use of CMAB009 Enritol for the first batch of patients, fully launched a marketing network and a series of academic promotion activities. We are actively applying to participate in exclusive medical insurance negotiations carried out by the China Health Insurance (“Health Insurance”) department to promote the rapid benefits of CMAB009 Enritol to the vast majority of cancer patients in China. 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; and 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 exceeds 10 million and continues to grow, and there is huge market demand that has not been met for a long time. In March 2022, Taizhou Pharmaceutical signed an exclusive promotion service agreement with Kexing Biopharmaceuticals Co., Ltd. (“Kexing Biopharmaceuticals”) (listed company on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock code: 688136)). Based on this, Taizhou Pharmaceutical has granted Kexing Biopharmaceutical an exclusive promotion license for CMAB008 to stop in mainland China (excluding Hong Kong, Macau and Taiwan).CMAB008 has already achieved online sales in all provinces in China. The terminals cover thousands of hospitals, primary care institutions and pharmacies of all levels. Sales in the first half of 2024 increased by 47% compared to the same period in 2023. We have also carried out thousands of CMAB008 special academic discussion activities, such as “The Case Is Popular,” “Going Straight,” and “Love Gathering.” In addition to routine indications, infliximab has also been 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 in children for the treatment of multisystem inflammatory syndrome (MIS-C) in children. We are also collaborating with medical experts to explore the application of CMAB008 in systemic inflammatory response and cardiovascular damage after cardiac arrest. Furthermore, for the welfare of low-income patients, we have continued to implement relief CMAB008 drug withdrawal activities to give back to the community; with the advancement of academic and social feedback for CMAB008 discontinued drugs, the CMAB008 discontinued market promotion was significantly effective, thus providing a solid impetus for continued rapid growth in product sales. The company has also initiated cooperation with partners that have long accumulated rich overseas market resources to rapidly expand overseas markets. At present, the company has begun registration and expansion work in more than 30 countries and/or regions, and has completed GMP inspections in 3 countries. Among them, Brazil, a member of the International Drug Inspection Cooperation Program (“PIC/S”), has passed the GMP inspection certification. The listing registration application for CMAB008 has also been approved by the Ministry of Health of Peru. For further details, please refer to the Company's announcement dated July 2, 2024. CMAB007 (Omalizumab α for injection): It was approved by the State Drug Administration for marketing 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 immunoglobulin E (“IgE”) mediated. It is the first domestically produced novel therapeutic antibody for allergic asthma approved by the State Drug Administration. In August 2023, CMAB007 was also 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 omexide for urticaria. As an anti-IgE monoclonal antibody, cMAb007 omexide is expected to expand its scope of application to allergic diseases such as allergic rhinitis and food allergies. In the future, we will actively carry out various studies to rapidly expand the R&D and treatment application of CMAB007 in various fields of allergic diseases. In 2023, Taizhou Pharmaceutical entered into an exclusive commercialization cooperation agreement with Jiangxi Jimin Kexin Pharmaceutical Co., Ltd. (“Jimin Kexin”), which has strong sales and promotion capabilities and rich experience, to commercialize CMAB007 in the Chinese market. CMAB007 was included in the national health insurance negotiation catalogue as an exclusive product and successfully negotiated into the medical insurance catalogue in the fourth quarter of 2023. Up to now, CMAB007 has completed procurement networking on all provincial and group procurement organization (“GPO”) platforms in mainland China, covering thousands of hospitals, primary care institutions and pharmacies. As an exclusive variety included in the medical insurance catalogue, a large number of academic activities have been carried out since its launch, covering nearly a thousand leading medical experts, and data analysis and research on the efficacy and safety of CMAB007 in the real world was initiated in early 2024. The CMAB007 Asthma Research Fund has successively set up 18 projects to study and enrich the evidence-based medical evidence for this product. Sales increased rapidly in the first half of 2014, increasing by more than 778 per cent compared with sales in the second half of 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 the phase I clinical trial of CMAB015 and started the phase III clinical trial. CMAB807/CMAB807X (desumab) has completed phase III clinical trials for osteoporosis, is compiling NDA application data, and plans are being made to implement full indication registration with reference to international precedents. 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 channels and expert resources accumulated over many years in specific disease fields, and on the other hand, build and enhance our own unique efficient sales system from specific fields of indications. 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. The new 7,500-liter GMP production line built by our company has entered the commissioning and 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 exclusive medical 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 also begun global market development, successfully passed the GMP inspection and certification of PIC/S member countries, achieved approval for the first overseas drug, and further accelerated the registration and marketing of our drugs in the international market.