Candonilimab

Cadonilimab plus platinum-based chemotherapy improved progression-free and overall survival in advanced cervical cancer compared to placebo, showing significant clinical benefits.

Akeso's cadonilimab and ivonescimab included in China's NRDL, effective Jan 1, 2025, for treating cervical cancer and EGFR-mutated nsq-NSCLC, respectively.

The National Reimbursement Drug List (NRDL) faces budget pressure and competition, with 445 drugs passing formal review in 2024. Oncology, immunology, neurology, and rare diseases see strategic positioning and comparator choices as key. Contract renewals and re-negotiations are under pressure, emphasizing clear messaging and data preparation for NRDL success.

Small cell lung cancer (SCLC) often responds well initially but later relapses. New treatments like Imdelltra, Trilaciclib, Durvalumab, and Lurbinectedin have been FDA approved. Clinical trials are ongoing for treatments like Ivonescimab, PM8002, Adebelimab, IBI3009, YL201, ZG006, and Tarlatamb, focusing on extensive stage SCLC.

Jefferies analyst Chris Lui maintained a Buy rating on Akeso, Inc. (9926) with a HK$102.00 price target. The company's shares closed at HK$69.50. Lui covers Healthcare stocks and has an average return of -6.1% with a 44.05% success rate. Akeso, Inc. has a market cap of HK$62.38B and a P/E ratio of -73.46. The company is a clinical-stage biopharmaceutical firm focused on oncology, immunology, and other therapeutic areas.

Data from the phase III COMPASSION-16 trial show that adding the PD-1 × CTLA4 bispecific antibody cadonilimab to chemotherapy plus bevacizumab improves outcomes in recurrent or metastatic cervical cancer patients.

Cadonilimab plus platinum-based chemotherapy significantly improves PFS and OS in patients with persistent, recurrent, or metastatic cervical cancer, according to a phase 3 trial published in *The Lancet*. Median PFS was 12.7 months with cadonilimab vs. 8.1 months with placebo (HR, 0.62; 95% CI, 0.49-0.80; *P* <.0001). Median OS was not reached with cadonilimab vs. 22.8 months with placebo (HR, 0.64; 95% CI, 0.48-0.86; *P* =.0011). Treatment-related adverse events were similar between groups.

Akeso's cadonilimab, a PD-1/CTLA-4 bispecific antibody, received NMPA approval for first-line treatment of locally advanced unresectable or metastatic gastric/G/GEJ adenocarcinoma in combination with fluoropyrimidine and platinum-based chemotherapy. The approval is based on the COMPASSION-15/AK104-302 study, which showed cadonilimab significantly reduced the risk of death across all PD-L1 expression levels, extending overall survival and demonstrating notable advantages in objective response and long-term survival.

Akeso, Inc. to present results from 13 clinical studies on cadonilimab, ivonescimab, ligufalimab, and penpulimab at ESMO Congress 2024, covering advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Key findings include ivonescimab's efficacy in mCRC and TNBC, and a Phase III study comparing anlotinib plus penpulimab versus sorafenib for HCC.