--- title: "Mabwell Biosciences, the next rising star in biotech profitability?" description: "The pharmaceutical market is unpredictable, with countless biotech companies trying to stand out from the fierce competition. However, Mabwell Biopharma has become the 'darling of the capital market' " type: "topic" locale: "en" url: "https://longbridge.com/en/topics/20463839.md" published_at: "2024-04-10T11:44:58.000Z" author: "[药械Talks](https://longbridge.com/en/profiles/6059509)" --- # Mabwell Biosciences, the next rising star in biotech profitability? The pharmaceutical market is unpredictable, with countless Biotech companies trying to stand out in the fierce competition. However, **Mabwell Biotech has become the 'star of the show' in the capital market with a six-month surge of up to 150%.** Recently, Mabwell Biotech released its 2023 financial report: total revenue reached 128 million yuan, a staggering year-on-year increase of 361.03%, once again thrusting it into the market spotlight. However, in the face of intense market competition, **can Mabwell Biotech maintain its strong growth momentum? Can its innovative drugs successfully 'go global' and become the key to turning losses into profits?** These are the focal points of market attention. **01** **Commercialized products increased to 3,** **covering multiple therapeutic areas comprehensively** **The 'biosimilars first' strategy has received positive market feedback.** In 2023, Mabwell Biotech underwent a 'transformation': achieving total revenue of 128 million yuan, **primarily from technical service income of 85.595 million yuan and drug sales revenue of 42.09 million yuan,** a 361.03% increase compared to the previous year. Among these, the technical service income mainly came from the 9MW3011 project, which entered into an exclusive licensing agreement with U.S.-based DISC MEDICINE, INC. and received a non-refundable upfront payment of $10 million; the drug sales revenue came from the sales of two commercialized products, Junmekang and Mailishu. **9MW3011** is Mabwell Biotech's globally first-in-class anti-TMPRSS6 monoclonal antibody, targeting rare diseases related to iron homeostasis, including β-thalassemia and polycythemia vera. **Currently, there are no mature and effective macromolecular treatments for these indications.** In January 2023, Mabwell Biotech granted Disc the exclusive rights to 9MW3011 in all regions except Greater China and Southeast Asia, receiving a total of up to $412.5 million in upfront and milestone payments (including an upfront payment of $10 million), as well as royalties of up to nearly double-digit percentages of the product's net sales. It is worth mentioning that after partnering with Disc, 9MW3011 successively received FDA Fast Track designation and Orphan Drug designation for the treatment of polycythemia vera. This means **9MW3011 is expected to accelerate its market entry in the future and enjoy policy benefits such as clinical fee reductions and seven-year market exclusivity.** **Among the already launched products,** Junmekang (adalimumab biosimilar) and Mailishu (project code: 9MW0311) were approved for market launch in March 2022 and March 2023, respectively. Among these, **Mailishu is the world's second approved Prolia (denosumab) biosimilar,** used for osteoporosis in postmenopausal women at high risk of fracture. A supplemental application will be submitted later to add the indication for osteoporosis in men at high risk of fracture. Although Mailishu has gained some first-mover advantage, it still faces significant competitive pressure. Currently, other approved competing products include Boan Biotech's Boyoubei and Qilu Pharmaceutical's Lukexin. Additionally, CSPC Pharmaceutical Group's JMT103 and Alphamab/Fountain Medical's KN012 have both entered Phase III clinical trials. **Faced with competition and performance pressure, it is imperative to find new growth points to enhance profitability.** In April this year, **Maijian (project code: 9MW0321)** was approved by the NMPA for market launch, used to treat giant cell tumor of bone that cannot be surgically removed or where surgical removal may cause severe dysfunction, including adult and skeletally mature (defined as at least one mature long bone and body weight ≥45kg) adolescent patients. **It has become China's first approved Xgeva (denosumab injection, 120mg) biosimilar.** From a market perspective, the original drug Xgeva was launched in China in 2019, with sales of 427 million yuan in 2022. In terms of biosimilars, Qilu Pharmaceutical and Boan Biotech have submitted market applications, while CSPC Pharmaceutical Group, Hansoh Pharma, and Hualan Genetic have entered Phase III clinical trials, indicating fierce competition. This means that although Mabwell Biotech has biosimilars approved in oncology, autoimmune, and metabolic fields, with commercialized products increasing to three, it is still far from covering the massive R&D expenditures. **02** **Charting a unique path 'going global',** **emerging markets become 'must-win territories'** Given the inherently competitive nature of biosimilars, **the key to success lies not only in speed but also in unique sales strategies.** Especially in the fiercely competitive domestic market, 'going global' has become a 'must-answer question'. Based on this, some pharmaceutical companies focusing on biosimilars, including Mabwell Biotech, have chosen to license their products externally to achieve 'sailing with others' boats', **and gradually shift towards emerging markets rather than mainstream European and American markets.** For example, Mabwell Biotech's **adalimumab biosimilar** has secured licensing partnerships with numerous overseas pharmaceutical companies, including Morocco's largest pharmaceutical group Sothema, ASEAN's top pharmaceutical companies UNILAB and UPL, covering regions such as Morocco, the Philippines, Argentina, Russia, and Eurasian Economic Union countries. Additionally, Mabwell Biotech has signed formal agreements for **9MW0311 (Prolia biosimilar)** and **9MW0321 (Xgeva biosimilar)** with six countries including Pakistan, Egypt, Thailand, Indonesia, Colombia, and Ecuador, as well as a supply and commercialization agreement with an Indian pharmaceutical company. The latter will obtain exclusive rights to import, produce, register, launch, and sell **9MW0813 (aflibercept biosimilar)** in India, along with non-exclusive rights in 10 countries including parts of South Asia and Africa. As of the disclosure date of the 2023 financial report, Mabwell Biotech has completed the signing of formal or framework agreements covering dozens of countries in overseas markets and has submitted registration application documents to countries such as Indonesia, Egypt, and Pakistan, continuously expanding its territory. **In fact, it's not just Mabwell Biotech. In recent years, domestic pharmaceutical companies like Bio-Thera Solutions and Henlius Biotech have also expanded their global reach to emerging markets.** After all, compared to mature markets like Europe and the U.S., emerging markets face relatively less competitive pressure, have lower entry barriers, and have a more urgent demand for moderately priced drugs, making it easier for pharmaceutical companies to gain market share and build brand awareness. Clearly, emerging markets and countries along the 'Belt and Road' have become must-win territories for Chinese pharmaceutical companies 'going global'. **03** **10 innovative drugs in the pipeline,** **several with global potential** In addition to charting a unique path 'going global', **Mabwell Biotech also has many highlights in its R&D pipeline.** As an innovative biopharmaceutical company, Mabwell Biotech has maintained high R&D investments, with figures of 623 million yuan, 759 million yuan, and 836 million yuan in the past three years, respectively. Although this has led to expanding losses, it has also positioned many innovative drugs at the forefront globally, **particularly three differentiated ADC pipelines with global potential.** As of the disclosure date of the 2023 financial report, Mabwell Biotech has 14 products in clinical or market stages, **including 10 innovative drugs** and 4 biosimilars, covering therapeutic areas such as autoimmune diseases, oncology, metabolism, ophthalmology, and infections. Among these, three products are already on the market, one is under market approval review, three are in Phase III pivotal registration clinical trials, and seven are in other clinical stages. ![Image](https://pub.pbkrs.com/social/2024/6059509/tED8g8yerVrjgbrckMcfQ5r2BSXNn7GR.jpg?x-oss-process=style/lg) Mabwell Biotech's R&D pipeline Source: 2023 financial report In the 2023 financial report, Mabwell Biotech clearly stated: it will focus on advancing international collaborations for pipelines with high innovation and clear differentiation advantages, including **Nectin-4 ADC (9MW2821)**, **B7-H3 ADC (7MW3711)**, **anti-ST2 monoclonal antibody (9MW1911)**, and **anti-IL-11 monoclonal antibody (9MW3811)**. **9MW2821 is the first Nectin-4 ADC in China to enter clinical trials, ranking second globally in progress,** with indications for advanced solid tumors: urothelial carcinoma is already in Phase III, cervical cancer and esophageal cancer are in Phase II, and positive data has been read out. For cervical cancer, the ORR and DCR for 37 evaluable patients were 40.54% and 89.19%, respectively; for advanced urothelial carcinoma, the ORR and DCR for monotherapy were 62.2% and 91.9%, respectively, with a median PFS of 6.7 months; for esophageal cancer, the ORR and DCR for 30 evaluable patients were 30% and 73.3%, respectively. It is worth mentioning that the world's first Nectin-4 ADC drug, **Padcev (Enfortumab Vedotin)**, achieved sales of 55.6 billion yen (approximately $1.03 billion) in 2023, a 68.1% year-on-year increase, becoming a 'blockbuster drug' within just four years of launch. According to Evaluate Pharma, Padcev's sales are expected to reach $4.7 billion by 2028. **This highlights the market potential of the Nectin-4 ADC field.** **7MW3711** is an ADC drug targeting B7-H3 developed based on the novel antibody-drug conjugate platform IDDCTM, demonstrating superior bystander killing effects compared to Daiichi Sankyo's DS7300 and showing good in vivo activity in multiple CDX and PDX models. It is currently in Phase I/II clinical trials for advanced malignant solid tumors. **As a next-generation ADC drug, B7-H3 ADC has attracted strong interest from foreign giants.** In October 2023, Merck invested $22 billion in total deal value to license three DXd ADC candidates from Daiichi Sankyo, including a B7-H3 ADC; shortly after in December, GSK licensed Hansoh Pharma's B7-H3 ADC HS-20093 for $1.71 billion in total deal value outside Greater China. **9MW1911** is an innovative monoclonal antibody targeting the IL33/ST2 pathway, with indications including asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis. Among these, COPD is already in Phase Ib/IIa clinical trials. Currently, no antibody drugs targeting ST2 or its ligand IL-33 are available globally. **9MW1911 is the first in China to enter clinical trials, ranking in the global second tier.** **9MW3811** is a humanized monoclonal antibody targeting human interleukin-11 (IL-11), with indications for advanced malignancies and idiopathic pulmonary fibrosis. Clinical trials are being conducted in China, Australia, and the U.S. **It ranks first in China and in the global first tier,** and when combined with PD-1 antibodies, it shows better anti-tumor efficacy. **04** **Conclusion** Mabwell Biotech's R&D strategy can be described as step-by-step and steady: first launching biosimilars, then cleverly using the 'going global' strategy to make its products stand out in overseas markets while also injecting continuous cash flow into the company. Now, many of Mabwell Biotech's R&D pipelines have entered late-stage clinical trials, poised for success, **especially those highly innovative and differentiated ADC pipelines, seemingly born for 'going global'.** Recalling those Biotechs that achieved profitability for the first time last year by licensing products 'going global', will Mabwell Biotech be the next? References: 1\. Mabwell Biotech financial reports, announcements, official WeChat 2\. Guosen Securities, Debon Securities, Soochow Securities research reports $Mabwell(688062.SH) $BOAN BIOTECH(06955.HK) $CSPC PHARMA(01093.HK) ### Related Stocks - [688062.CN - Mabwell](https://longbridge.com/en/quote/688062.CN.md) - [06955.HK - BOAN BIOTECH](https://longbridge.com/en/quote/06955.HK.md) - [01093.HK - CSPC PHARMA](https://longbridge.com/en/quote/01093.HK.md) --- > **Disclaimer**: This article is for reference only and does not constitute any investment advice.