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Boan Biotech Announces 2023 Half Year Results

2023 / 08 / 29 Publisher:Luye Life Sciences Group

Boan Biotech (6955.HK) announced its 2023 half year results and recent developments on August 27, 2023.

 

Highlights of 2023 half year results

Robust revenue growth

In the first half of 2023, the company’s revenue was RMB 261 million, up 18.4% year-on-year. Two products that have already been launched saw robust sales growth, with a sales network covering 2,000+ hospitals and other healthcare institutions across 31 Chinese provinces, municipalities and autonomous regions.

Improving profitability

Thanks to the improved management efficiency, the company achieved a 36% year-on-year reduction of sales, R&D and administrative expenses, and its losses were significantly reduced to RMB 120 million.

Efficient new product development

The company still saw fast progress in new product development despite the reduced R&D expenses. In the reporting period, the BLA for two products were accepted, the Phase III clinical trials of five products were taking place in China and abroad, and the IND for two products was approved. The company began to reap the benefits of the first major products it developed: apart from the two products that have already been launched, it will have five new products to be approved for launch over the next three years. In the first half of 2023, the company was recognized as a “National High-Tech Enterprise” in China.

Expanding production and improving efficiency

Boan Biotech is among a few Chinese biopharmaceutical companies that can do R&D, manufacturing and commercialization at the same time. The company is striving to further reduce costs and increase efficiencies by upgrading manufacturing processes, and is also expanding production capacity to meet the growing demand in the marketplace. In the reporting period, the company’s projects including Phase II of a smart production line for antibody drugs and plant digitalization were underway without a hitch. The company’s production site was recognized as a “Green Site of the Year” in 2023.

 

Recognized for revenue generation and commercialization

The successful launch and commercialization of two products contributed to the company’s robust revenue growth and sustainable operating cash flow. The company was approved by the HKEX in April to drop the "B" marker from its stock short name, which again attested to its strong revenue generation and commercialization capabilities.

The company’s first commercialized product Boyounuo® (bevacizumab injection or BA1101) continued to see robust sales growth in the reporting period, adding about 300 new healthcare institutions to the company’s sales network compared with the number at the end of 2022, to bring the total number to around 1,600. All the five indications of this product have been covered by the China’s National Reimbursement Drug List (NRDL), and real-world studies of the product are going on.

The company’s second commercialized product Boyoubei® (denosumab injection or BA6101) is the world’s first biosimilar to Prolia® approved for marketing. After it was launched at the end of last year, this product quickly achieved extensive market coverage. To date, Boyoubei has been quoted online for NRDL coverage and granted access to nearly 400 healthcare institutions in 31 Chinese provinces, municipalities and autonomous regions, and the company has established partnerships with over 1,000 dual-channel pharmacies and DTP pharmacies for the drug. The company granted CP Qingdao, a subsidiary of Sino Biopharm, the exclusive right to commercialize Boyoubei in the Chinese mainland, to unleash this product’s potential in the market together with the partner. 

 

Multiple products to be commercialized soon

Multiple candidates in the company’s pipeline are to be commercialized soon. They are expected to become the company’s strong growth engines after launched. In this year alone, the BLA for two products were accepted, and the Phase III clinical trials of five products were taking place in China and abroad:

  • In oncology, the BLA for BA1102 (denosumab injection) was accepted in China;
  • In oncology, the BLA for BA1101 (bevacizumab injection) was accepted in Brazil;
  • In ophthalmology, all subjects were enrolled for the Phase III clinical trial of BA9101 (aflibercept intravitreous injection) in China;
  • In metabolism, all subjects were enrolled for the Phase III clinical trial of BA5101 (dulaglutide injection) in China;
  • In oncology, the Phase III clinical trial of BA1104 (nivolumab injection) began in China;
  • Subjects were being enrolled for the Phase III clinical trials of BA1102 and BA6101 in Europe, the United States and Japan simultaneously.

 

Multiple first-in-China innovations

In addition to the soon-to-be-commercialized biosimilars, Boan Biotech is also accelerating the development of antibodies on its proprietary antibody platforms and beginning to take a forward-looking step by building a platform for cell therapies. By building new platforms and optimizing existing ones on an ongoing basis, the company is raising the bar for competition and improving its core competitive edge, to ensure the development of more innovative drugs and therapies going forward.

Boan Biotech has successfully developed seven innovative antibodies on its three antibody platforms: the Human Antibody Transgenic Mouse and Phage Display Platform, the Bispecific T-cell Engager Platform, and the Antibody-drug Conjugate (ADC) Platform. In the reporting period, the IND for two more products was approved, and the development of several other products was ahead of the competition in China:

  • The IND for BA1202 was approved, making it the first innovative bispecific antibody targeting CEA and CD3 to undergo a clinical trial in China;
  • The Phase I clinical trial of BA1106 began, making it the first innovative anti-CD25 antibody for treating solid tumors to undergo a clinical trial in China;
  • The Phase I clinical trial began for BA2101, a long-acting anti-IL-4Rα antibody for treating autoimmune diseases;
  • The IND for BA1301 was approved, and the Phase 1 clinical trial already began for this candidate ADC targeting Claudin18.2.

In the field of cell therapies, Boan Biotech focuses on the next-generation enhanced and regulatable CAR-T cells to develop novel therapies for treating solid tumors by taking advantage of non-viral delivery systems. The company’s innovative and differentiated cell therapy preparation platforms “STEALTH CAR-TTM” and “ReceptorTACTM” are developed based on non-viral delivery systems, enhanced and regulatable structures, and the non-genome editing technique for protein degradation. By doing these, the company hopes to achieve new breakthroughs in developing cell therapies for treating solid tumors. 

 

Expanding commercial production

Boan Biotech is expanding production capacity to support further commercialization. Currently, the company has a commercial production capacity of 8,000 liters and a pilot production capacity of 1,700 liters. This year, it will build three 2,000-liter commercial production lines and four 500-liter pilot production lines. The company plans to build three more 2,000-liter commercial production lines and 2,700-liter pilot production lines in 2024. The company is also striving to reduce costs and increase efficiencies by building digital plants and smart production lines or upgrading manufacturing processes. Moreover, the company has put into place a comprehensive quality management system complying with Chinese, U.S. and EU standards. In the reporting period, the production facilities for BA6101 and BA5101 passed the QP audit of the EU, the production facility for BA1101 passed the pre-audit for GMP in Brazil, and the production facility for BA1102 passed the field audit for product registration and the GMP audit in China. This ensures that the company’s products meet international quality standards.

Looking ahead, Jiang Hua, Chairlady and CEO of Boan Biotech, said: “Thanks to a highly integrated and coordinated internal operating system, Boan Biotech is balanced on multiple fronts today, including commercial, R&D and management activities. On top of this, we’ll continue to accelerate the clinical development of our core products across global markets, expand our portfolio of innovative antibodies, improve our in-house manufacturing capabilities and global commercialization capabilities, and actively seek business collaborations. We look forward to launching five new products in China and abroad over the next three years, to make great strides towards our goal of becoming a leading biopharmaceutical company in the world."

 

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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'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 two commercial products. Its pipeline includes 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. and the EU. 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. This has laid a solid foundation for its long-term, high-quality growth.

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