Chongqing-Based Biopharma Maiwei Announces $2.8B Bone Health Innovative Drug Project with New HKEX Filing

On December 16, Mabwell announced that it intends to enter into the “Mabwell Bone Health Innovative Drug Project Contract” with the Administrative Committee of Chongqing High-Tech Zone and Chongqing Zhongxin Pharmaceutical and Big Health Private Equity Investment Fund Partnership (Limited Partnership) (hereinafter referred to as the “Big Health Fund”).Mabwell (Chongqing) Biopharmaceutical Co., Ltd. (“Mabwell Chongqing”), a wholly-owned subsidiary of Mabwell, will serve as the operating entity for this project to jointly invest in and construct the “Mabwell Bone Health Innovative Drug Project” within the directly administered park area of Chongqing High-Tech Zone.

According to the announcement, leveraging the advanced manufacturing base for biological drug CDMO in the Western (Chongqing) Science City, the project will utilize approximately 3,500 square meters of plant/building space. With a core focus on bone health, it will localize the R&D of related pipeline innovative drugs, drug approvals (including the Drug Production License B), commercial-scale production, commercialization rights, and sales in the Chongqing High-Tech Zone.The project plans for a total investment of RMB 2 billion, of which Mabwell will contribute no less than RMB 1.6 billion (RMB 1.008 billion in this round) in the form of intangible assets, and the Big Health Fund intends to invest a total of RMB 400 million (RMB 200 million in this round) in cash.

Under the agreement, Mabwell Chongqing will obtain the rights to research, manufacture, sell, commercialize, and promote Maileishu, with the specific scope of rights covering both the domestic market in China and all international markets.Mabwell Chongqing will also establish a national marketing center for Mailishu, conducting clinical registration studies and post-marketing clinical trials (including real-world studies, etc.) for marketed drugs such as Mailishu, with the aim of expanding indications.

The Administrative Committee of Chongqing High-Tech Zone will support Mabwell in listing its biological drugs at medical institutions in Chongqing, and facilitate the promotion of Mabwell’s Milishu through citywide benefit programs and value-added services such as “Yu Kuai Bao,” aiming to cover an elderly population of over 1 million people annually.

Mailsu is a denosumab biosimilar (the reference product is Amgen’s Prolia). Denosumab is a first-line, broad-spectrum anti-fracture risk medication internationally. It blocks the binding of RANKL to its receptor RANK on the surface of osteoclasts and their precursors. By inhibiting the RANKL/RANK interaction, it suppresses osteoclast formation, function, and survival, thereby reducing bone resorption and increasing the bone mass and strength of both cortical and trabecular bone. It is a true bone-targeted therapeutic agent.

Prolia was first approved for marketing in the United States and Europe in 2010 for the treatment of osteoporosis, and it entered the Chinese market after receiving approval in 2020. According to Amgen’s annual report, Prolia generated $4.048 billion in revenue in 2023, representing a 12% year-on-year increase. Based on a report by Frost & Sullivan, the market size of denosumab for osteoporosis in China is projected to reach RMB 7.8 billion by 2030.

The vast market has naturally attracted fierce competition among numerous pharmaceutical companies. Currently, five denosumab biosimilars have been approved for marketing in China, originating from Boan Biotech, Mabwell, Alphamab Oncology, CSPC Pharmaceutical Group, and Qilu Pharmaceutical. Additionally, denosumab biosimilar pipelines from several other pharmaceutical companies are in clinical development. According to incomplete statistics, there are more than 40 RANKL-targeting drugs under development or already approved globally, of which over 30 are denosumab biosimilars.

Mabwell’s Mailishu is the second denosumab biosimilar approved for marketing worldwide.In March 2023, MaiLiShu was approved for the treatment of osteoporosis in postmenopausal women at high risk for fractures; in postmenopausal women, MaiLiShu significantly reduces the risk of vertebral, non-vertebral, and hip fractures. In April 2023, MaiLiShu completed its first commercial shipments, with a total of 84,474 units shipped throughout 2023.

Since its commercial launch, MaiLiShu has rapidly scaled up volume, driving substantial growth in drug sales revenue. According to Mabwell’s 2024 interim report, the product recorded 116,994 additional units shipped and gained access to 487 new hospitals in the first half of the year, with sales already surpassing the full-year total for 2023. Publicly available data indicate that MaiLiShu has completed bidding and online listing processes in 28 provinces and established provincial-level medical insurance reimbursement linkages in 29 provinces. It is currently accessible in 605 hospitals and covered by 2,061 pharmacies.

In fact, as early as 2023, Mabwell had already established its presence in the Western (Chongqing) Science City to invest and operate. In collaboration with Zhi’en Biopharma, China-Singapore Fund, and other industrial partners, it co-established the Western Science City Biologic Drug MAH Cluster, which incubates drug candidates through a cluster of Marketing Authorization Holder (MAH) companies. The cluster is gradually introducing nine blockbuster biologics to the Science City, including ongoricimab, denosumab, and dupilumab. These drugs cover multiple therapeutic areas such as metabolic diseases, autoimmune disorders, bone health, oncology, and respiratory diseases. The initiative aims to build a comprehensive biologics industry chain encompassing regulatory registration, commercial-scale manufacturing, and post-marketing sales services, thereby strengthening the Science City’s high-end manufacturing capabilities in cell therapy innovative drugs and biologics CDMO.

In China, where the vast territory is seeing widespread development in biomedicine, why has Mabwell shown a “preference” for Chongqing, settling in this mountainous city that does not stand out in the biomedical industry? There are many reasons.

First, regarding Mabwell’s flagship product, Mai Li Shu, Chongqing has a sufficiently large patient market.Chongqing ranks among the highest in China for its aging population ratio, with over 5.88 million residents aged 65 and above. According to the Seventh National Population Census, Chongqing’s aging rate has reached 21.87%, ranking fifth nationwide and first in western China; the proportion of the population aged 65 and above accounts for 17.08% of the total population, ranking second nationwide and first in western China. Osteoporosis is listed by the World Health Organization (WHO) as one of the three “invisible killers” affecting the health of the elderly. This project focuses on advancing denosumab for the treatment of osteoporosis. Through fund investment and industrial innovation, it aims to leverage the ecosystem and explore a new governance model for an aging society characterized by “health management + scientific prevention and control + multi-party collaborative governance.” The project integrates bone health screening, prevention, and treatment into public health initiatives targeting the elderly, while utilizing digital technologies and other new tools to widely and effectively conduct science popularization and patient education, thereby benefiting a broader population.

Furthermore, in recent years, Chongqing’s pharmaceutical industry chain has been progressively refined, with rapid enhancements in both innovation and industrialization capabilities. Companies establishing operations in the region can access comprehensive support within the industrial cluster.Currently, Chongqing is accelerating the construction of a “1+5+N” biopharmaceutical industrial system. The “1” refers to building one national-level biopharmaceutical industry cluster centered on the Chongqing International Bio-city. The “5” denotes five key agglomeration areas—Liangjiang New Area, Chongqing High-Tech Zone for Western (China) Science City, Changshou Economic and Technological Development Zone, Fuling District, and Dadukou District—as the backbone for accelerating the development of industrial bases with concentrated industries. The “N” encourages other qualified industrial parks to develop specialized biopharmaceutical parks based on their unique characteristics, thereby gradually optimizing the industrial layout. Among these, Liangjiang New Area and Chongqing High-Tech Zone for Western (China) Science City are focusing on establishing research and incubation bases as well as comprehensive biopharmaceutical industry clusters featuring high-end chemical drugs and medical devices; Changshou Economic and Technological Development Zone is prioritizing the development of the active pharmaceutical ingredient (API) industry; Fuling District is continuously strengthening its modern traditional Chinese medicine (TCM) industry; and Dadukou District is deeply cultivating and enhancing its in vitro diagnostics (IVD) industry.

Moreover, Chongqing has been generous in its investment in the biopharmaceutical sector, providing robust support for early-stage biopharmaceutical projects that require substantial capital.Since last year, biomedical investment funds have continued to emerge in Chongqing: Chongqing announced the establishment of a RMB 200 billion industrial investment fund-of-funds, with pharmaceuticals as a key sector; Banan District of Chongqing contributed RMB 1 billion to establish a private equity fund as special development capital for the biomedical industry; Liangjiang New Area set up its first life and health specialized fund of RMB 500 million under the framework of a RMB 22 billion industrial development fund-of-funds; the Western (Chongqing) Science City Industrial Development Fund has a total scale of up to RMB 30 billion, established by Chongqing Hi-Tech Development Group and Xiyong Microelectronics Park Company as investors, with an initial scale of RMB 10 billion; Chongqing Bonded Port Area Group announced the establishment of a RMB 2 billion specialized sub-fund for biomedicine.

In addition to the aforementioned factors, Chongqing boasts numerous other advantages in the biopharmaceutical sector. As a municipality directly under the Central Government, it offers faster administrative approval processes compared to other cities in central and western China. Furthermore, Chongqing is home to provincial-level testing institutions characterized by high authority and broad technical coverage, which also accelerates the qualification application process.

According to data from China Economic Weekly, as of July 5 this year, Chongqing had 78 A-share listed companies, with more than 10 in the biopharmaceutical industry. Three biopharmaceutical companies had market capitalizations exceeding RMB 10 billion. Among them, Zhifei Biological Products was the biopharmaceutical company with the highest market capitalization among Chongqing’s listed firms, ranking third overall among all A-share listed companies in Chongqing, behind only Seres and Changan Automobile. Additionally, according to data from the Chongqing Municipal Commission of Commerce, as of July 5, Chongqing had more than 180 pharmaceutical manufacturers and over 370 medical device manufacturers, including 121 specialized, refined, distinctive, and innovative (“Little Giant”) enterprises, as well as 15 listed companies.

Therefore, in recent times, an increasing number of pharmaceutical investors have been traveling to Chongqing, and multiple media outlets have begun reporting on the city’s strategic initiatives and transformations in the investment and biopharmaceutical sectors—a scenario rarely seen in the past. With the support of various comparative advantages, Chongqing’s pharmaceutical industry is taking off rapidly.

References:

1. VCBeat, “Chongqing Just Secured Its First Class 1 Innovative Drug: When Will It Truly Shine in the Pharmaceutical Sector?”

2. Chongqing Drug Administration, “Chongqing Intensifies Layout of the Biopharmaceutical Industry”