On the evening of August 29, Mabwell(Shanghai)Bioscience Co.,Ltd. (688062.SH, stock price 48 yuan, market cap 19.18 billion yuan) released its 2025 half-year report. The company achieved revenue of 101 million yuan in the first half of this year, down 12.43% year-over-year, with attributable net profit of -552 million yuan, representing a wider loss compared to the same period last year.

The company's stock price reached an intraday high of 50.36 yuan per share on August 29, setting a new historical record. As of the August 29 close, the company's stock price had gained over 137% year-to-date.

Beyond submitting a listing application to the Hong Kong Stock Exchange in January this year, the company has also attracted market attention through BD (business development) activities, including the approval of its first self-developed innovative drug Maili Sheng (generic name: Agastim alfa for injection), a BD collaboration with leading domestic generic drug manufacturer Qilu Pharmaceutical, and a BD partnership with Google-affiliated anti-aging giant Calico for another drug.

Currently, the company is focusing its BD efforts on multiple ADC (antibody-drug conjugate) pipeline products. ADC has become a concentrated area for major transactions with increasingly fierce competition, and the company recently acknowledged during site visits that "BD business inherently carries uncertainty."

Since listing on the Science and Technology Innovation Board in 2022, Mabwell Bioscience has maintained a pace of approximately one product approval per year. From 2022 to 2024, the company's three approved products - Junmaikai (generic name: adalimumab injection), Mailishu (generic name: denosumab injection for osteoporosis in postmenopausal women at high risk of fracture), and Maiweijian (generic name: denosumab injection for inoperable giant cell tumor of bone) - were all biosimilar drugs.

Among these, the two denosumab products achieved sales revenue of 99.54 million yuan in the first half of this year, up 51.59% year-over-year, serving as the company's primary revenue driver.

However, these three biosimilar drugs each face commercialization challenges: Junmaikai's shipment volume declined 66.61% year-over-year to 48,800 units in 2024 due to partner production capacity constraints and channel contraction; the denosumab market totals only 863 million yuan (with original developer Amgen holding 853 million yuan according to MENET database); Maiweijian, approved only for giant cell tumor of bone indication, faces disadvantages against originator Xgeva's three indications, shipping only 12,500 units for the full year.

Against this backdrop, the company's first self-developed Class 1 innovative drug Maili Sheng (generic name: Agastim alfa for injection) received approval in May for reducing the incidence of febrile neutropenia associated with cancer chemotherapy, marking a crucial step in the company's transition from biosimilar drugs to innovative drugs.

One month after Maili Sheng's approval, Mabwell Bioscience exclusively licensed the rights for development, production, improvement, utilization, and commercialization of the product in China to Qilu Pharmaceutical, with the company eligible to receive upfront payments and sales milestones totaling up to 500 million yuan.

In the same month, the company also exclusively licensed the rights for development, production, and commercialization of IL-11 targeted therapy (including 9MW3811) in all regions except China to US company CALICO, with the company eligible to receive near-term, development, registration, and commercialization milestone payments, plus tiered royalties based on net sales of licensed products, totaling up to $571 million.

Against the backdrop of a warming innovative drug sector and frequent industry transactions, Mabwell Bioscience's popularity stems from the two BD deals mentioned above. However, the company had BD activities as early as 2023 during a challenging fundraising environment.

In that year, Mabwell's wholly-owned subsidiary Mabwell (US) signed a licensing agreement with DISC for 9MW3011 (TMPRSS6-targeting monoclonal antibody for polycythemia vera, β-thalassemia, and other conditions), eligible to receive up to $412.5 million in upfront and milestone payments, plus royalties of up to nearly double-digit percentages of net sales.

According to the half-year report, the company's revenue decline in the first half of this year was related to the high revenue recognition from the exclusive licensing agreement, with no licensing revenue realized in the first half and a significant reduction in technical service income.

In July this year, the company also signed licensing and commercialization agreements with Philippine company UNILAB for two denosumab injection products 9MW0311 and 9MW0321. Under the agreement, UNILAB will handle registration and sales in the Philippines, while Mabwell Bioscience will be responsible for development, production, and commercial supply.

According to the investor relations activity record disclosed on August 28, the company reiterated that 2025 is a very critical year for the company's innovative drug BD business. The IL-11 monoclonal antibody has completed BD implementation, and the company will continue to advance collaborations for several other pipeline products.

From a cash flow supplementation perspective, such transactions clearly benefit the company: as of March 31 and June 30, the company's cash and cash equivalents were 1.137 billion yuan and 1.389 billion yuan, respectively.

Like most biotech companies, Mabwell Bioscience has yet to achieve profitability, with cumulative losses of approximately 5.721 billion yuan from 2017 to 2024. In the first half of this year, the company's R&D investment reached 392 million yuan, up 21.72% year-over-year, accounting for 388% of operating revenue.

The company stated that the increased loss in the first half was related to substantial investment in advancing clinical trials for pipeline products, with multiple pipeline products in critical registration clinical research stages leading to high R&D expenses.

Currently, Mabwell Bioscience has 14 key products in preclinical, clinical, or marketed stages, including 10 innovative drugs and 4 biosimilar drugs. Beyond the 4 marketed products, there is 1 pending New Drug Application (NDA) submission and 2 in Phase III pivotal registration clinical stages.

Besides long-acting G-CSF (granulocyte colony-stimulating factor) represented by Maili Sheng, ADC drugs constitute an important component of the company's pipeline. Among the 3 ADC drugs the company disclosed for BD advancement, 7MW4911's clinical trial application officially received FDA clearance in August this year to conduct Phase I/II studies on safety, pharmacokinetics, and efficacy for advanced colorectal cancer and other advanced gastrointestinal tumors. Review by China's National Medical Products Administration is still ongoing.

According to the report "From Introduction to Leadership: A Decade-Long Comprehensive Perspective on China's Innovative Drug Transactions," China's License-out transactions exploded from 2020, with ADC and bispecific antibody drugs becoming the main forces for overseas expansion, with companies like Kelun-Biotech and Baili-Bio achieving multiple major transactions through technological breakthroughs.

However, this also means more intense BD competition. How should the company respond? The answer may lie in new pipelines. Mabwell Bioscience indicated that starting from 2026, the company's key BD pipelines will include globally differentiated pipelines based on next-generation TCE (T-cell engager) platforms. On July 3, when hosting 127 institutional investors including Essence Securities Fund and Bosera Asset Management, the company stated that the core of its TCE platform involves modifying CD3-targeting antibodies, with plans to achieve clinical applications for multiple innovative pipelines by 2026.

It's noted that CD3 antibodies are primarily used for developing bispecific antibodies rather than ADC drugs.