Founded in 1996, Baili Tianheng is the first batch of private pharmaceutical enterprises to start with the business of chemical generics and Chinese patent medicines. In 2010, the company began to innovate and transform, trying the research and development of small molecule innovative drugs and biologics. In 2023, the company and BMS reached a global blockbuster cooperation agreement on BL-B01D1 (with an initial payment of US$800 million, a near-term contingent payment of US$500 million and a potential milestone payment of US$7.1 billion), and its R&D capabilities were recognized by MNC, opening a new era of internationalization. The company's core product BL-B0ID1 is expected to apply for NDA to NMPA in 2025, and is expected to usher in the first year of commercialization of innovative drug business in 2026. We are optimistic about the company's long-term development, and it is expected that the company's net profit attributable to the parent company in 2025-2027 will be -9.05/-10.66/-2.691 billion yuan, and EPS will be -2.26/-2.66/-6.71 yuan respectively, covering for the first time and giving a "buy" rating.

BL-B01D1

is the world's first EGFRxHER3 ADC drug independently developed by the company. As of the company's 2024 annual report, BL-B01D1 has conducted nine phase III clinical trials in China, covering lung cancer, breast cancer, esophageal squamous cell carcinoma and nasopharyngeal carcinoma and other indications. Among them, 3L nasopharyngeal carcinoma and 2L esophageal squamous cell carcinoma are expected to submit NDAs to the NMPA in 2025, and multiple 2L NSCLC and BC indications are expected to submit NDAs in 2026. In October 2024, BMS launched an international multi-center Phase I clinical trial of BMS-986507 (BL-B01D1) in combination with drug K or osimertinib in combination with multiple solid tumors, and is expected to carry out the first 2~3 overseas registered phase III clinical trials in 2025.

Differentiated ADC Platform + Global Leading Multi-Antibody Platform FIC and BIC Pipeline

Over the past decade, the company has built the world's leading ADC drug discovery platform (HIRE-ADC platform), innovative multi-specific antibody drug discovery platform (GNC platform), specific enhanced bispecific antibody platform (SEBA platform) and innovative ARC (nuclear medicine) research and development platform (HIRE-ARC platform).

The BL-B01D1 (EGFR/HER3 ADC) has successfully proven the strength of the HIRE-ADC platform. The global research and development of polyclonal antibody drugs is in the early stage of research, and no products have been approved for marketing. The company has a number of bispecific/multi-specific T cell engagers into clinical trials, leading the world.

Risk warning: failure of drug clinical research and development, drug safety risks, loss of core members, deterioration of industry competition pattern, etc.