- Fast progress in R&D: Boyoubei, the first denosumab biosimilar in the world developed by the company, was launched; 1 drug candidate entered the Biological License Application (BLA) stage, 2 saw significant progress with their Phase 3 clinical trials (including BA5101, the world's first dulaglutide biosimilar to enter Phase 3 clinical trials), and 5 innovative antibodies as drug candidates entered Phase 1 clinical trials.
- A new journey in the capital market: Boan Biotech was listed on the Main Board of the Hong Kong Stock Exchange (HKEX) on December 30, 2022, and was included in the Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect on March 13, 2023.
Eye-catching performance of two marketed products
Boan Biotech's first drug Boyounuo (bevacizumab injection, a biosimilar to Avastin®) is used for the treatment of multiple cancers. Sales grew rapidly immediately after it was launched in China in May 2021. Its first full-year sales were approximately RMB 515 million in 2022, which was a remarkable performance. Two new indications (ovarian cancer and cervical cancer) were also added for the drug last year, to further expand its patient base. Today, all the five indications of Boyounuo are on the 2022 National Reimbursement Drug List (NRDL).
Boyoubei(denosumab injection, a biosimilar to Prolia®), the company's second product, was launched in China for the treatment of osteoporosis in November 2022. This is the world's first marketed denosumab biosimilar. In addition to China, the company is also developing the product in Europe and the U.S., with a plan to market it globally.
Thanks to the strong sales performance of Boyounuo and the company's well-established commercial capabilities, Boyoubeiquickly achieved a number of business milestones in a shorter period of time after its approval. In December 2022, the drug was granted a code for reimbursement by the government's health insurance system. In January 2023, the company granted CP Qingdao, a subsidiary of Sino Biopharm, the exclusive right to commercialize Boyoubei in the Chinese mainland, to put the product on the fast track for commercial success.
A fast growing pipeline with multiple first movers
Boan Biotech is able to innovate efficiently, and all of its products are in-house developed. The company has three platforms for innovation: the Human Antibody Transgenic Mouse and Phage Display Platform, the Bispecific T-cell Engager Platform, and the Antibody-drug Conjugate (ADC) Platform. On these platforms, Boan Biotech has built a strong portfolio, which includes 2 commercial products, 7 investigational antibodies, and 4 biosimilar candidates. Since 2022, the company has made remarkable progress in the development of multiple investigational drugs.
3 biosimilar candidates to be commercialized: BA1102 (denosumab injection, a biosimilar to Xgeva®), the BLA of which has been accepted in China, and which is also being developed in Europe and the U.S.; and BA5101 (dulaglutide injection, a biosimilar to Trulicity®) and BA9101 (aflibercept intravitreous injection, a biosimilar to Eylea®), both of which are in Phase 3 clinical trials in China, with BA5101 being the world's first dulaglutide biosimilar to enter Phase 3 clinical trials.
5 innovative antibodies under Phase 1 clinical trials: BA1106, a non-IL-2 blocking anti-CD25 antibody, which is the first innovative anti-CD25 antibody for the treatment of solid tumors to enter the clinical trial stage in China; BA2101, an anti-IL-4Rα monoclonal antibody, which is the first long-acting anti-IL-4Rα antibody in the autoimmunity therapeutic area to enter the clinical trial stage in China; BA1105, an ADCC-enhanced anti-Claudin 18.2 antibody, which is expected to become the best-in-class targeted therapy for the treatment of metastatic pancreatic cancer, advanced gastric cancer, and adenocarcinoma of the esophagogastric junction; BA1201, an anti-PD-L1/TGF-β bispecific antibody fusion protein; and BA1301, an injectable ADC targeting Claudin18.2.
Boan Biotech keeps a balance between "the value of innovation" and "commercial visibility". While striving to build a differentiated portfolio, it is also speeding up R&D to gain a first-mover advantage. Many of the above-mentioned drug candidates are ahead of competition in terms of development progress. They set a clear path for the company's commercialization efforts in the short term, and also lay a solid foundation for its long-term sustainable growth.
Strong commercial capabilities ensure successful new product launch
Boan Biotech is one of a few Chinese biopharmaceutical companies operating across the value chain of the industry from research and development to manufacturing and commercialization. The company's highly integrated and coordinated internal operation system enabled it to be able to "produce blood" on its own in a shorter period of time. Besides, the company also has strong commercial capabilities, which ensure the successful launch of its investigational drugs later on.
Boan Biotech has been reinforcing its commercial capabilities by leveraging its own professional marketing team and its strategic partners. On the one hand, the company has established an extensive distribution network covering more than 1,300 hospitals and other institutions nationwide. On the other hand, it is joining hands with strong industry partners such as AstraZeneca, CP Qingdao, and OcuMension and leveraging their resources to unleash the clinical value and market potential of its products. In addition, the company has subsidiaries in the U.S. and Singapore, and also has a growing international R&D team and business development team to support the rapid growth of its business.
Moreover, to further support commercialization, in 2022, Boan Biotech ramped up the effort to increase production capacity, and also embraced digital management and upgraded production processes in an effort to reduce cost and increase efficiency. Currently, the company has a total capacity of 8,000 liters for commercial production and 1,700 liters for pilot production. It is also building two 3*2,000-liter lines for commercial production and two 2*500-liter lines for pilot production.
Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: "It's very exciting and encouraging to see remarkable breakthroughs and accomplishments of our company in 2022 despite various challenges posed by COVID-19 and a changing industry landscape. Looking forward, we expect 2023 to be a banner year for the revenue growth of our commercial products and a transformative year for accelerating our pipeline of innovative antibodies. Next, we will further accelerate the clinical development of our key products around the world, expand our portfolio of innovative antibodies, beef up our manufacturing and commercial capabilities, and build partnerships, as we want to meet patient needs, reward our shareholders, and give back to communities with more high-quality innovations."
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About Boan 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 discovers antibodies on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform, and ADC Technology Platform. Boan Biotech operates across the entire value chain of the industry from antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, and technology transfer to pilot and commercial production.
Boan Biotech's portfolio currently includes two commercialized products, multiple investigational antibodies 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. and the EU. Due to the company's differentiated product portfolio and well-established commercialization capabilities, Boan Biotech has built a comprehensive industry value chain operation system covering "R&D - production - commercialization", laying a solid foundation for long-term and high-quality development.
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