Incident 1: BMS updates clinical promotion plans for BL-B01D1 in 2025, or multiple catalyst readings. BMS recently released its 2024 Q3 report, and its investor presentation updated the clinical plan for BL-B01D1 2025. On the one hand, BMS expects to read out some of the results of the Phase I slope climbing clinical trial of 01D1 for solid tumors in 2025 and regards this as one of the key milestones in 2025-2026; on the other hand, BMS plans to launch registered clinical trials of BL-B01D1 in 2025. We believe these two events may be important catalysts for Bailey Tianheng 2025.

Incident 2: At the 2024 American Hematology Annual Meeting (ASH), the company announced some climbing data from the CD33 ADC phase BL-M11D1I clinical trial, showing good therapeutic potential for r/r AML. 2024 ASH will be held from December 7 to 10, 2025 in San Diego, USA. Recently, ASH officially disclosed the details of the summary. Bailey Tianheng and Systimmune announced some climbing results of their CD33 ADC phase BL-M11D1I clinical trial: As of June 25, 2024, a total of 39 r/r AML patients had been included in the trial, and the dose had climbed from 0.65 mg/kg to 2.75 mg/kg. No dose limit toxicity has been observed; safety is controllable. Adverse effects above grade 3 include hypokalemia (25.6%), pneumonia (15.4%), infection (12.8%), etc., and no grade 3 or above were observed Organ damage and any venous occlusive disease; M11D1 showed good therapeutic potential. ORR of 14.3% (1/7), 42.9% (6/14), and 50% (2/4) were observed in the 1.65, 2.25, and 2.75 dose groups, respectively. According to our summary, the efficacy of M11D1 alone in high doses is comparable to targeted drug combination chemotherapy regimens.

Profit forecast. We expect the company to achieve net profit of 4.089/-0.129/-0.905 billion yuan in 2024-2026, corresponding EPS of 10.20/-0.32/-2.26 yuan, respectively. Using the DCF valuation method, the corresponding reasonable value range is 214.73 to 226.83 yuan, giving a “superior to the market” rating.

Risk warning: Drug research and development progress falls short of expected risk, drug sales fall short of expected risk, competition increases risk, policy risk;