New Stock News | Miweibi (688062.SH) submitted a second application to the Hong Kong Stock Exchange. It already has three commercially available biosimilar products.

According to the disclosure of the Hong Kong Stock Exchange on March 25th, Maiwei (Shanghai) Biotechnology Co., Ltd. (Maiwei Biotechnology (688062.SH)) submitted its listing application to the main board of the Hong Kong Stock Exchange, with CITIC SEC and HAITONG INT'L as the joint sponsors. This is the company's second submission to the Hong Kong Stock Exchange. The prospectus shows that as of the last practicable date, Maiwei Biotechnology has three commercialized biosimilar drug products, namely Mileshu, Maiweijian, and Junmaikang. Company Introduction According to the prospectus, Maiwei Biotechnology was established in 2017 and is a well-known Chinese pharmaceutical company with innovative capabilities in drug research and development, as well as end-to-end capabilities from drug discovery to commercialization. The company's A shares have been listed on the Shanghai Stock Exchange's Science and Technology Innovation Board (stock code: 688062) since January 2022. The company's core product 9MW2821 (bulumtatug fuvedotin ("BFv")) is an antibody-drug conjugate (ADC) targeting Nectin cell adhesion molecule 4 ("Nectin-4"). In addition, the company has established a pipeline product portfolio consisting of more than 13 different types of drug assets. Maiwei Biotechnology's self-developed core product 9MW2821 is an ADC technology product. According to Frost & Sullivan data, as of the last practicable date, in terms of clinical development stage, 9MW2821 is the fastest progressing Nectin-4 ADC used to treat urothelial carcinoma in China, second only to Padcev (the only FDA-approved Nectin-4 ADC) globally. According to the same data source, 9MW2821 is also the first Nectin-4 ADC to enter into Phase III trials for cervical cancer globally. The company is conducting multiple clinical trials for 9MW2821, including (i) Phase III trials for the treatment of urothelial carcinoma with 9MW2821 as monotherapy or in combination with pembrolizumab, a PD-1 antibody drug approved for the treatment of a variety of solid tumors; (ii) Phase III trials for the treatment of cervical cancer with 9MW2821 as monotherapy; (iii) Phase II trials for the treatment of triple-negative breast cancer with 9MW2821 as monotherapy or in combination with pembrolizumab; and (iv) Phase II clinical trials for the treatment of advanced esophageal cancer with 9MW2821 as monotherapy. As of the last practicable date, Maiwei Biotechnology has obtained 140 patents worldwide and filed 276 patent applications, including 25 patents and 17 patent applications related to the core product. Maiwei Biotechnology continues to develop and upgrade ADC drug development platforms, integrated high-efficiency antibody discovery platforms, and TCE bis/thre... Financial Information Income In the financial years 2024 and 2025, the company achieved revenues of approximately RMB 2 billion and RMB 6.59 billion, respectively. Losses for the Year/Period In the financial years 2024 and 2025, the company incurred losses of approximately RMB 10.47 billion and RMB 9.72 billion, respectively. Industry Overview In terms of the market size of oncology drugs, there were 21.3 million new cases of cancer worldwide in 2024, and it is estimated to reach 25.5 million cases by 2032. As of 2024, lung cancer, breast cancer, and colorectal cancer were the top three cancer types globally. In China, as of 2024, lung cancer, colorectal cancer, and thyroid cancer were the top three cancer types in terms of incidence. The global market size of oncology drugs increased from USD 143.5 billion in 2019 to USD 253.3 billion in 2024, with a compound annual growth rate of 12.0%, and is expected to further increase to USD 375.9 billion in 2028 and USD 548.2 billion in 2032, with compound annual growth rates of 10.4% and 9.9% from 2024 to 2028 and 2028 to 2032, respectively. The Chinese oncology drug market increased from USD 26.4 billion in 2019 to USD 35.9 billion in 2024, with a compound annual growth rate of 6.3%, and is expected to grow rapidly to USD 54.3 billion in 2028 and USD 99.2 billion in 2032, with compound annual growth rates of 10.9% and 16.3% from 2024 to 2028 and 2028 to 2032, respectively. Urothelial carcinoma is currently the most common type of bladder cancer, accounting for about 90% of all bladder cancers. This cancer originates from the urothelial cells inside the bladder, ureter, and renal pelvis. The global incidence of urothelial carcinoma increased from 508,200 cases in 2019 to 572,900 cases in 2024, and is expected to further increase to 634,200 cases in 2028 and 701,000 cases in 2032, with compound annual growth rates of 2.6% and 2.5% from 2024 to 2028 and 2028 to 2032, respectively. In China, the incidence of urothelial carcinoma increased from 76,300 cases in 2019 to 89,000 cases in 2024, and is expected to further increase to 98,800 cases in 2028 and 108,600 cases in 2032, with compound annual growth rates of 2.7% and 2.4% from 2024 to 2028 and 2028 to 2032, respectively. Triple-negative breast cancer refers to a type of breast cancer that is negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). Triple-negative breast cancer accounts for about 15% to 20% of all breast cancer cases globally and is considered the most aggressive subtype due to the lack of specific treatment targets. Triple-negative breast cancer is usually diagnosed more frequently in younger and premenopausal women. The global incidence of triple-negative breast cancer increased from 320,100 cases in 2019 to 364,900 cases in 2024, and is expected to further increase to 382,400 cases in 2028 and 405,900 cases in 2032, with compound annual growth rates of 1.2% and 1.5% from 2024 to 2028 and 2028 to 2032, respectively. In China, the number of cases of triple-negative breast cancer increased from 49,500 cases in 2019 to 55,900 cases in 2024, and is expected to further increase to 58,600 cases in 2028 and 60,400 cases in 2032, with compound annual growth rates of 1.2% and 0.7% from 2024 to 2028 and 2028 to 2032, respectively. Globally, the annual sales of the top five commercial ADC drugs in 2024 exceeded USD 1 billion each. Board of Directors Information The board of directors consists of ten directors, including five executive directors, one non-executive director, and four independent non-executive directors. The directors serve a term of three years and may be re-elected. According to relevant laws and regulations in China, independent non-executive directors may not serve more than six consecutive years. Equity Structure Prior to editing, the company's shareholders were (i) Longrun Equity owning approximately 35.18%; (ii) Zhongjun Jianlong owning approximately 5.01%; (iii) Zhu Investment owning approximately 1.70%; and (iv) Longrun Investment Consulting owning approximately 0.49%. Longrun Equity is a limited partnership, with Mr. Tang Chunshan, an executive director, and his spouse, Ms. Chen Shanna (both limited partners), and Longrun Investment Consulting (its only general partner) owning approximately 79.92%, 19.98%, and 0.10%, respectively. Longrun Investment Consulting is owned 88.30% by Mr. Tang and 11.70% by Ms. Chen. Zhongjun Jianlong and Zhu Investment are employee incentive platforms and limited partnerships, controlled by Mr. Tang in his capacity as their respective sole general partner. According to the directors, there are no controlling shareholders parties have entered into any agreement related to the company. Therefore, Mr. Tang and Ms. Chen collectively control approximately 42.38% of the company's issued share capital through Longrun Equity, Zhongjun Jianlong, Zhu Investment, and Longrun Investment Consulting, and as of the previous edit, they constitute a group of controlling shareholders under the listing rules. Zhongjun Jianlong and Zhu Investment are both employee incentive platforms and limited partnerships controlled by Mr. Tang as their respective sole general partners. Longrun Equity is a limited partnership, owned by Mr. Tang and Ms. Chen (as limited partners) and Longrun Investment Consulting (as the sole general partner). Advisory Team Joint Sponsors: CITIC SEC (Hong Kong) Limited, HAITONG INT'L Capital Limited Company Legal Advisors: Davis Polk & Wardwell, Jingtian & Gongcheng Law Firm, Hogan Lovells Legal Advisors of Joint Sponsors: Smithfield Solicitors, King & Wood Mallesons Auditors and Reporting Accountants: Ernst & Young Hua Ming LLP Industry Consultant: Frost & Sullivan Consulting (Beijing) Co., Ltd. Shanghai Branch Compliance Advisor: SOMERLEY CAP Limited_COMPANY