FIRST SHANGHAI released a research report highlighting significant progress in AKESO's (09926) core product pipeline. Cadonilimab has been approved for cervical and gastric cancer indications and included in the national reimbursement list, with multiple new indications entering Phase III trials. Ivonescimab shows promising data in non-small cell lung cancer (NSCLC), with overseas marketing applications underway. Penpulimab has successfully received FDA approval. Additionally, several products are either included in the reimbursement list or in late-stage clinical trials. Using the DCF valuation method, the target price is set at HK$144.9, representing a 23.4% upside from the current price, warranting a "Buy" rating. Key points from FIRST SHANGHAI include:
**Financial Performance** In the first half of 2025, AKESO's product revenue grew 49.2% year-on-year to RMB 1.40 billion. Including licensing fees, total revenue reached RMB 1.41 billion, with a gross margin of 79.4%. R&D expenses increased 23.0% to RMB 730 million. By late August 2025, the company raised HK$3.493 billion net through a share placement of 235.5 million shares at HK$149.54 per share, bringing its net cash position to RMB 5.8 billion post-placement.
**Pipeline Progress** 1. **Cadonilimab (AK104, PD-1/CTLA-4)**: Approved for 1st-3rd line cervical cancer and 1st line gastric cancer, now reimbursed. Phase III trials are ongoing for PD-(L)1-resistant gastric cancer, hepatocellular carcinoma (HCC) adjuvant therapy, unresectable HCC, 1st line PD-L1-negative NSCLC, and NSCLC post-chemoradiotherapy. Breakthrough therapy designation was granted in April 2025 for IO-resistant squamous NSCLC, with global Phase II trials for IO-resistant HCC and Phase III for 1st line gastric cancer.
2. **Ivonescimab (AK112, PD-1/VEGF)**: Approved in May 2024 for EGFR-mutated NSCLC and included in the 2025 reimbursement list. Updated OS data from Summit’s HARMONi study showed HR=0.78 (p=0.0332), with a notable North America subgroup HR=0.70. Summit plans to submit a BLA to the FDA in Q4 2025. For 1st line PD-L1-positive NSCLC, OS interim analysis (39% maturity) revealed a 22.3% reduction in death risk (HR=0.777 vs. pembrolizumab). China’s NMPA accepted the NDA for 1st line squamous NSCLC in July 2025. Phase III trials are ongoing for IO-resistant NSCLC, limited-stage SCLC, 1st line biliary tract cancer, colorectal cancer, pancreatic cancer, PD-L1-positive head and neck squamous cell carcinoma, and triple-negative breast cancer. Summit is also conducting Phase III trials for 1st line NSCLC (HARMONi-3), with enrollment targets set for 2026-2027.
3. **Penpulimab (AK105, PD-1)**: FDA-approved in April 2025 for 1st/2nd line nasopharyngeal carcinoma, marking AKESO’s first fully independent FDA-approved innovative biologic, validating its R&D and manufacturing capabilities.
4. **Efmarodocokin alfa (AK102, PCSK9) and Efonodocokin alfa (AK101, IL-12/IL-23)**: Included in the 2026 reimbursement list.
5. **Gumokimab (AK111, IL-17)**: NDA for moderate-to-severe psoriasis accepted in January 2025.
6. **Other Products**: Phase III trials for lemzoparlimab (AK117, CD47), plozalizumab (AK109, VEGFR-2), and mupadolimab (AK120, IL-4R); global Phase I trials for AK138D1 (HER3 ADC) and AK146D1 (Trop2/Nectin4 ADC), with plans for combination therapies.
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