Dongao Pharma Crosses Key Milestone with Over RMB 1 Billion in Annual Revenue and First-Ever Full-Year Profit

● The company’s performance exceeded expectations, with full-year revenue surpassing RMB 1 billion to reach RMB 1,098,329 thousand, representing a year-on-year increase of 41%. Product sales revenue amounted to RMB 877,410 thousand, up 39% year on year, primarily driven by the core product Puxinting.^®Steady growth in the sales volume of (Bevacizumab Injection). CDMO/CMO business revenue reached RMB 207,133 thousand, a year-on-year increase of 47%. Self-sustaining capabilities continued to strengthen, with net cash flow from operating activities remaining positive for three consecutive years, reaching RMB 116,403 thousand in 2024.

●Significant achievements have been made in the strategic transformation of CDMO, and sales of self-developed products are steadily increasing.In 2024, the company achieved profitability for the first time, with a full-year net profit of RMB 34,757 thousand.

● CDMO business demonstrates strong growth potential with a pronounced funnel effect; leveraging advanced technology platforms to strengthen front-end client acquisition has led to a significant increase in early-stage projects.. A total of 58 new projects were added throughout the year, including 48 ADC projects, bringing the cumulative total to 153 projects. During the year, the company successfully secured two Pre-BLA (pre-Biologics License Application, covering pivotal clinical trials and new drug application stages) projects, increasing the portfolio in hand to eight. This fully demonstrates the company’s excellent capabilities in late-stage commercial CDMO projects and strengthens the potential for future revenue growth. Signed but uncompleted orders on hand reached RMB 191 million, a year-on-year increase of 39%.

● The company’s high-standard quality management system has gained widespread recognition from the industry both domestically and internationally,The company has successfully undergone multiple on-site production inspections by drug regulatory authorities, GMP compliance audits across various countries, as well as numerous GMP inspections conducted by clients and third-party consulting firms. In 2024 alone, the company underwent a total of 38 GMP audits, including 7 official GMP audits (3 international and 4 domestic) and 2 EU Qualified Person (QP) audits, one of which was passed with zero defects. The company obtained GMP certificates from countries such as Colombia, Egypt, and Indonesia. Meanwhile, the company also received the Certificate of Foreign Manufacturer Registration from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), indicating that Tot Biopharm’s production lines and quality system comply with Japanese standards for pharmaceutical product quality and safety. Furthermore, the company has repeatedly supported clients in facilitating inspections by multinational corporation (MNC) pharmaceutical partners and regulatory agencies, successfully assisting clients in obtaining authorizations and earning high recognition.

● Sales continued to grow, with full-year sales volume increasing year-over-year42%。

● Actively advancing overseas marketing authorization applications. As of December 31, 2024, marketing authorization applications have been initiated in 34 countries, with submissions accepted in 20 countries. The first approval in an overseas market is expected to be obtained in 2025, thereby opening up international markets.

● Annual CDMO/CMO Revenue (RMB)207,133 thousand yuan, year-on-year increase47%, with ADC project revenue accounting for86%(including antibody production).

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● Leveraging its cutting-edge technology platform, the company strengthened its capabilities in early-stage project acquisition. New projects added throughout the year58 items, among which48 itemsFor ADC projects.

● Cumulative to8Pre-BLA (pivotal clinical trials and new drug application stage) projects, with new additions throughout the year2 units。 

● Clinical-stage orders related to overseas markets continue to increase, with multiple successful collaborations enabling clients to pass inspections by multinational pharmaceutical company (MNC) partners and secure licensing approvals.

● Alongside the high-quality delivery of projects, the number of company audits has continued to rise. Multinational pharmaceutical companies have consistently provided positive feedback during their visits, demonstrating strong recognition of the company’s quality system. Favorable outcomes from customer and regulatory agency audits have validated the company’s service capabilities spanning from clinical development to commercial manufacturing.

● The company’s quality management system complies with Chinese, U.S., and EU GMP standards, earning extensive recognition from the industry both domestically and internationally.

● A robust quality system is key to facilitating the success of customer projects. In 2024 alone, the company underwent a total of 38 GMP audits, including 7 official audits and 2 EU QP audits.

● Obtained the Foreign Manufacturer Accreditation Certificate from Japan’s PMDA (Pharmaceuticals and Medical Devices Agency), ushering in a new chapter for CDMO services in Japan.

● Successfully supported clients in multiple inspections by overseas MNC pharmaceutical partners, resulting in successful authorization.

● Co-developed GL-DisacLink with Tangling Bio^®ADC Site-Specific Conjugation Technology Platform: Deepen Exploration, Expand Applications, and Sustain Momentum.

● Established strategic partnerships to introduce “OS One-Step Conjugation” and HydroTrio technologies.

● Proprietary BDKcell™ Cell Line Development Platform, delivering high-yield, high-quality stable cell lines with antibody expression levels reaching up to12g/L, has already facilitated the development of various antibodies.

● The company operates four complete commercial production lines aligned with top-tier international brands (two for antibodies and two for ADCs), comprising five drug substance workshops (including a non-toxic conjugation drug substance workshop) and four drug product workshops.

● The completion and commissioning of the company’s second high-end ADC commercial formulation line has successfully facilitated the production of dozens of batches, including several pre-BLA projects.

● The Company ranks among the top in China in overall scale of biological drug CDMO services and is a leading domestic enterprise with one-stop ADC CDMO production capacity.

● To support the rapid growth of our CDMO business and promote continuous advancement in the educational qualifications of team members, 75% of the CDMO team holds a bachelor’s degree or higher.

● Enhanced core business capabilities, with the ADC CDMO team achieving a 17% year-over-year growth; 85% of team members hold master’s or doctoral degrees, ensuring high-quality project advancement.

● The core executive team has an average of 15+ years of work experience at renowned overseas multinational corporations.

● Operating revenue is RMB1,098,329 thousand yuan, representing an increase of RMB 317,700 thousand, or 41%, from RMB 780,629 thousand in 2023.

● R&D Expenses (RMB)79,313 thousand yuan, representing a decrease of RMB 24,577 thousand from RMB 103,890 thousand in 2023, primarily attributable to the streamlining of the product pipeline and the further concentration of R&D resources on ADC CDMO process development and technological innovation.

● Selling expenses were RMBRMB 606,711 thousand, representing an increase of RMB 165,692 thousand from RMB 441,019 thousand in 2023, primarily attributable to higher personnel and activity expenses driven by expanding market demand, as well as a year-on-year increase in marketing and promotional expenses resulting from higher sales volume of self-developed products.

● General and administrative expenses were RMBRMB 81,375 thousand, representing an increase of RMB 13,065 thousand from RMB 68,310 thousand in 2023, primarily due to the expansion of the Company’s scale and the enhancement of its management system.

● Net cash inflow from operating activities was RMB116,403 thousand yuan; net profit amounted to RMB 34,757 thousand, compared with a net loss of RMB 37,757 thousand in 2023, marking the first return to profitability in 2024.