Bevacizumab Biosimilar (Boan Biological)

* Strong growth of RMB 190 million in net profit * Time to reap the benefits of R&D Boan Biotech (6955.HK) today announced its annual results for fiscal year 2024 and latest developments. In the reporting period, the company's total revenue was RMB 726.3 million, up 17.5% YoY; its gross profit was RMB 542.6 million, up 32.7% YoY, and its gross margin was increased significantly by 8.6% to 74.7%; its EBITDA was increased by RMB 201 million YoY to turn around from a negative figure last year to a positive figure of RMB 179 million; and its net profit turned around from a negative figure last year to a positive figure of RMB 73.19 million, up RMB 193 million YoY, marking the first time for the company to become profitable in a whole calendar year.  One of the first Chinese biotech companies turning profitable thanks to its strong commercial capabilities The portfolio of Boan Biotech is characterized by innovation plus a balanced risk profile. By commercializing biosimilars first, the company is able to generate cash quickly while funding new drug development. Now it’s time for the company to reap the benefits of its first R&D investments. By leveraging its strong commercial capabilities to cash on those products, Boan Biotech has become one of a few biotech companies in China to deliver a profitable year. Boyounuo®（Left）、Boyoubei®（Middle）、Boluojia®（Right） The company has launched three products. In the reporting period, their combined sales were RMB 690 million, accounting for 95% of its total revenue in the period. Two of them, Boyounuo® (BA1101, bevacizumab injection) and Boyoubei® (BA6101, denosumab injection 60mg), have been sold to approximately 3,000 hospitals and institutions across China. The company partnered with Qingdao Conson Pharmaceutical to commercialize Boyoubei®, resulting in a three-fold sales increase from 2023. The third product, Boluojia® (BA1102, denosumab injection 120mg) for the treatment of giant cell tumor of bone, was approved for marketing in China in May 2024, an addition to the company’s portfolio.  Fueling long-term, high-speed growth through innovation At its core, Boan Biotech pursues a strategy to serve patients around the world through innovation. The company develops innovative biologics with the potential to become first-in-class or best-in-class drugs on three platforms: the Antibody-drug Conjugate (ADC) Technology Platform, the Bispecific T-cell Engager Technology Platform, and the Human Antibody Transgenic Mouse and Phage Display Technology Platform. They will help to build a competitive edge for the company to achieve long-term, high-speed growth.  Currently, Boan Biotech has two investigational ADCs, one bispecific antibody, and two monoclonal antibodies undergoing Phase 1/2 clinical trials. Among them: ● BA1302 (an anti-CD228 ADC): the world's only innovative anti-CD228 ADC under clinical development, currently undergoing a Phase 1 clinical trial. ● BA1301 (an anti-Claudin18.2 ADC): currently undergoing a Phase 1 clinical trial in China, and granted the Orphan Drug Designation (ODD) in the U.S. for the treatment of gastric cancer and pancreatic cancer. ● BA1106 (a non-IL-2 blocking anti-CD25 antibody): the first innovative anti-CD25 antibody in China undergoing a Phase 1 clinical trial for the treatment of solid tumors, with the data of the trial to be presented at this year’s annual meeting of the American Association for Cancer Research (AACR) soon. Boan Biotech pursues an “IO+ADC” development strategy. The company is also exploring opportunities for combination therapies based on its own PD-1 and VEGF inhibitors in an effort to improve the efficacy of current standard of cares, to enhance the value of its pipeline, and to increase the success rate of new drug development. Accelerating growth through diverse partnerships Boan Biotech adopts a business model driven by in-house development and partnership building. The company is actively seeking various partnership opportunities, working together with leading partners in China and abroad to drive high-speed growth. With its product development and commercialization activities gaining momentum, the company is catching attention and winning recognition in the industry for its commercial value and innovation capability.  In China, the company has granted Joincare the exclusive rights to develop and commercialize BA2101 (a long-acting anti-IL-4Rα monoclonal antibody) for the treatment of respiratory diseases, has granted Kexing Biopharm the exclusive right to commercialize Boyoubei® (BA6101, denosumab injection 60 mg) and Boluojia® (BA1102, denosumab injection 120 mg) in Hong Kong and Macao, has granted Zencore Biologics the non-exclusive right to use the company's proprietary BA-HIEXcell® platform to develop stable cell lines in the Chinese mainland, has granted Qingdao Conson Pharmaceutical the exclusive right to commercialize Boyoubei® (BA6101, denosumab injection 60 mg) in the Chinese mainland, and has conducted a Phase 3 clinical trial of Boyoujing® (BA9101, aflibercept intravitreous injection) with Ocumension and granted them the exclusive commercialization right for the product in the Chinese mainland. Internationally, the company has entered into strategic partnerships on Boyuno® (BA1101, bevacizumab injection), Boyoubei® (BA6101,  denosumab injection 60 mg), and Boluojia® (BA1102, denosumab injection 120 mg) in several countries, to keep expanding its global footprint. The company is also in talks with potential partners both in China and abroad on multiple projects ranging from preclinical candidates to post-market products, including both innovative biologics and biosimilars. Increasing productivity through smart manufacturing With the rapid development of biopharmaceutical technologies, the requirements for drug quality and accessibility are growing. Boan Biotech is upgrading its production system using digital tools with a focus on smart manufacturing. The company’s production lines are designed to be intelligent from the very beginning. By optimizing processes, updating equipment, improving management, and adopting smart manufacturing, it is able to constantly improve manufacturing. In 2024, the company’s digital facility was recognized as a provincial digital facility in Shandong. Boan Biotech has put into place a quality management system conforming to Chinese, American, European, and Japanese standards. The system has been certified by four major internationally recognized standards: ISO 9001, ISO 14001, ISO 45001, and ISO 50001. In addition, the production facility has passed the GMP inspection by Brazil’s ANVISA resulting in “no observation”, and the QP audit of the European Union. Increasing efficiency through highly integrated operations Boan Biotech is one of a few Chinese biopharmaceutical companies with an integrated operation system allowing it to develop, manufacture and sell products on its own. The highly integrated system helps to drive efficient commercialization and lay a solid foundation for lean management and long-term growth. In the reporting period, the company’s gross profit was increased by 32.7% YoY, far above its revenue growth, and its gross margin was 74.7%, up 8.5% YoY. The increased profitability was mainly attributed to the upgraded production process and reduced production cost of Boyounuo® (bevacizumab injection). Next, the company will continue to drive the cost optimization for its marketed products and its pipeline. On the R&D front, despite the reduced R&D budget, the company is concentrating resources on high-potential candidates. In the reporting period, it obtained one marketing authorization (MA), moved forward the review process of three Biologics License Applications (BLAs), and advanced Phase 3 trials for three investigational drugs and Phase 1/2 trials for five others. On sales and management, by taking multiple measures at the same time such as optimizing its organizational structure, increasing the productivity of its employees, exploring the use of AI, and innovating with its business model, the company was able to constantly reduce its sales and management expenses in the reporting period. Most notably, its management expenses were substantially reduced by 10.1% YoY, whereas its profitability and competitiveness were further increased. Ushering in an expected wave of product approvals during 2025-2027 From 2025 to 2027, Boan Biotech is expected to launch multiple new products both in China and abroad, which will include the following:  ● Boyouping® (BA5101, dulaglutide injection): currently under review for its BLA in China, expected to be approved for marketing this year. It has also been cleared by the U.S. FDA for clinical trials, giving it a leading edge with respect to the development process both in China and abroad. ● Boyoujing® (BA9101, aflibercept injection): also under review for its BLA in China, expected to be approved for marketing this year. ● Boluojia® (BA1102, denosumab injection 120mg): expected to be approved in China this year for the treatment of bone metastases from solid tumors and multiple myeloma as the company works on the BLA. ● Boyuno® (BA1101, bevacizumab injection): under review for its BLA in Brazil, expected to be approved for marketing this year. ● Boluojia® (BA1102, denosumab injection 120mg) and Boyuoubei® (BA6101, denosumab injection 60mg): expected to finish the international multicenter Phase 3 clinical trials in Europe, the U.S., and Japan this year, followed by the submission of a BLA in major international markets. ● BA1104 (nivolumab injection): undergoing a Phase 3 clinical trial in China with a leading edge in the development process. The U.S. FDA has also agreed on a "streamlined" clinical approach for BA1104, meaning that only one pharmacokinetics (PK) similarity study (Phase 1) is sufficient to support the submission of a BLA with no Phase 3 study needed. Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: “We’re moving full steam ahead towards our strategic goals. We’ve already launched three products, our revenue in 2024 was four times higher than in 2021, and we turned profitable for the first time in a whole calendar year. I’m very proud of these accomplishments.  In 2025, we’ll focus on launching four new products (including new indications for existing products), accelerating the clinical development and BLA submission for two products in overseas markets, tapping the clinical value of multiple innovative biologics, and seeking strategic partnerships on key drugs or drug candidates. I’m confident that, by working as one, our company will be able to maintain high-speed growth in the next three years, to deliver better products for our patients, and to reward our shareholders for their support with better results.”  About Biotech Boan Biotech (6955.HK) is a fully-integrated biopharmaceutical company developing, manufacturing, and marketing biologics, with a focus on oncology, autoimmune diseases, ophthalmology, and metabolic diseases. The company's drug discovery activities revolve around multiple platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, ADC Technology Platform and Cell Therapy Platform. Boan Biotech operates across the entire value chain of the industry covering antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, technology transfer, non-clinical research, clinical research, regulatory affairs and registration, and commercial production. In the cell therapy field, Boan Biotech focuses on a new generation of enhanced and regulated CAR-T technology, developing safer, more effective, and affordable treatments for patients. Boan Biotech’s portfolio includes three products approved for marketing. Its pipeline includes two investigational drugs under review for their marketing applications, multiple novel biologics as drug candidates protected for their international intellectual property rights, and a number of biosimilar candidates. In addition to China, the company is also developing biopharmaceutical products in overseas markets, including the U.S., the EU, and Japan. With a differentiated portfolio and well-established commercial capabilities, Boan Biotech operates across the industry’s value chain from research and development to manufacturing and commercialization, laying a solid foundation for long-term, high-quality growth in the future.