Major oncology cooperation is highly collaborative with existing pipelines: The company recently established a strategic partnership with Boehringer Ingelheim (BI) to jointly develop and commercialize BI oncology pipelines in mainland China, including three assets in clinical development, brigimadlin, zongertinib, and BI 764532, as well as several innovative drug candidates in the early stages. Product revenue will be included in China Biopharmaceuticals' consolidated financial statements. The company expects that the total peak sales of the three mid- to late-stage products in mainland China will reach 5 billion yuan (before 2030), and the sales profit margin confirmed by Zhongsheng will reach double digits. In the future, the two sides are expected to further expand their cooperation to other key disease fields.
Brigimadlin (MDM2-p53 antagonist): The world's first murine bipolar homologous gene 2 (MDM2) -p53 antagonist to enter registered clinical trials, and has the potential to become a global co-target FIC. Currently, 5-7% of cancer patients express MDM2 mutations. Clinical trials on brigimadlin include: 1) compared to first-line treatment of advanced DDLPS (phase II/III) with doxorubicin; patients have now been enrolled and NDA is expected to be submitted as soon as possible; in the previous phase Ib trial of brigimadlin for DDLPS, ORR/DCR was 19.0%/84.8%, respectively, and mPFS reached 8.1 months; 2) brigimadlin treated with BTC and other solid tumors (phase II); 3) brigimadlin Glioblastoma (stage 0/Ia) is treated in combination with radiation therapy. The company expects the product to be launched in China in 2025.
Zongertinib (selective HER2 inhibitor): Can target both wild-type and mutant HER2 receptors (including exon 20 mutations). Traditional HER2-targeted therapies have limited efficacy against exon 20 mutations, and ADC has certain safety challenges, so this variety is expected to become a first-line treatment.
In the phase Ib trial of Zongertinib treated ≥2L HER2 TKD mutant NSCLC, ORR/DCR reached 73.9%/91.3%; ≥3 grade TREs were 5.3% (120mg QD)/13.0% (240mg QD), which was safer than HER2 ADC. The company expects the product to be launched in China in 2027.
BI 764532 (DLL3/CD3 dual-specific T cell connector): Compared with Amgen and Baekje drug candidates using the BiTE molecular form, BI 764532 uses the traditional IgG molecular structure that has been scientifically proven, and the drug is more definitive. In phase I trials of ≥2L treatment of SCLC, LCNEC, or ePNEC, ORR reached 25% (dose ≥90μg/kg) and DCR 52%. Level 3 TREs greater than or equal to 27%. The company's anlotinib has been approved for 3L SCLC. Combined with PD-L1 treatment, 1L SCLC is expected to be approved in 2Q24. After BI 764532 is approved for marketing, it is expected to form a more complete product matrix with anlotinib for 1-3 line SCLC treatment. The company expects the product to be launched in China in 2028.
Maintaining the purchase rating: We believe that this partnership will further consolidate the company's multi-target layout in the field of solid tumors, have strong synergy with existing products, and increase the company's revenue and profits. We maintain our purchase rating and target price of HK$4.80, and we are optimistic about the recovery of performance in 2024 and the continued realization of the value of the innovation pipeline.