Akeso, Inc. announced that the company were seek to achieve the followings potential milestones that may take place in 2024 and into early 2025: Approval of four NDAs/sNDAs across five indications; NDAs/sNDAs filing across four indications for three drugs; Topline data readout from up to five registrational trials; Completing enrollment for up to four registrational trials; and Initiating up to five new Phase III trials. In addition, the company continues to plan for first-in-human clinical trials for a range of products currently in preclinical evaluation, including, for the first time, an antibody-drug conjugate (ADC). Updated Clinical Data and Milestone Outlook for Ivonescimab (PD-1/VEGF Bispecific): The company currently has three Phase III clinical trials for ivonescimab at varying stages of progress: AK112-301, for which the NDA has been submitted for approval to the CDE, AK112-303, for which enrollment has completed, and AK112-306, for which the company are currently enrolling.

The company present updated data from its Phase II clinical trials, supporting the company's rapid development of ivonescimab across multiple indications. Updated Data for AK112-201 (NCT04736823): AK112-201 is an open-label, Phase II study evaluating ivonescimab plus chemotherapy across three cohorts. The patients with tumors of squamous histology in Cohort 1 help support the company's decision to initiate the AK112-306 Phase III clinical trial comparing ivonescimab against tislelizumab plus chemotherapy; the patients in Cohort 2 supported the company's earlier decision to enter into AK112-301 comparing ivonescimab plus chemotherapy against chemotherapy alone.

For Cohort 1, the frequency of treatment-emergent adverse events (TEAEs) leading to discontinuation of ivonescimab was 11%; there were no treatment-related adverse events (TRAEs) leading to the death of a patient. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and decreased white-blood cell counts. In Cohort 2, ivonescimab had an acceptable safety profile.

There were no TRAEs leading to permanent discontinuation of therapy or patient death. Key Near-Term Milestones of Ivonescimab: For the NDA for ivonescimab based on AK112-301, a decision from the Chinese Center for Drug Evaluation (CDE) is expected in Second Quarter 2024, along with a read-out of topline data from the study. Ivonescimab is expected to become the world's first bispecific drug combining immunotherapy and anti-angiogenesis.

Phase III data readout of ivonescimab monotherapy versus pembrolizumab monotherapy as first-line treatment for NSCLC patients with positive PD-L1 expression is expected in Second Quarter 2024. Based on this data, the Company will submit an NDA for this indication as appropriate. Phase III enrollment completion of ivonescimab in combination with chemotherapy versus tislelizumab in combination with chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC is expected in the second half of 2024.

Phase III completion by Summit of the global enrollment of ivonescimab (AK112/SMT112) combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR -TKI is expected in the second half of 2024. Potential initiation of Phase III clinical trials for ivonescimab in additional tumor types in 2024. Milestone Outlook for Cadonilimab (PD-1/CTLA-4 Bispecific): Following the Company's benchmark sales of cadonilimab, the first PD-1/CTLA-4 bispecific antibody, in 2023, the Company is poised to achieve additional important breakthroughs in 2024 that will significantly enhance clinical and commercial value.

In January 2024, the NMPA accepted the sNDA for cadonilimab in combination with chemotherapy as first-line treatment for recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. NDA submission of cadonilimab + chemotherapy ± bevacizumab for first-line treatment for advanced cervical cancer is expected in First Quarter 2024. Phase III enrollment completion of cadonilimab for adjuvant treatment of hepatocellular carcinoma (HCC) is expected in Fourth Quarter 2024.

Phase III data readouts for first-line GC/GEJ cancer and first-line cervical cancer in 2024. Potential initiation of Phase III clinical trials for cadonilimab in additional tumor types in 2024. Other Potential Milestones for Oncology Products: In terms of other significant oncology drug milestones, the Company is expected to reach several important milestones in 2024 to early 2025.

Two bispecific antibodies, AK129 (PD-1/LAG3) and AK130 (TIGIT/TGFß), are anticipated to enter Phase II, while ADC and neurodegenerative diseases candidates will undergo human clinical trials for the first time. Additionally, the CDE will also make a decision on the NDA for penpulimab for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). Finally, additional combination therapy data is anticipated to be announced.

Key Near-Term Milestones of Non-Oncology Products: NDA decision expected in 2024 on ebronucimab (PCSK9) for the treatment of hypercholesterolemia and heterozygous familial hypercholesterolemia. NDA decision expected in 2024 on ebdarokimab (IL-12/IL-23) for the treatment of moderate-to-severe psoriasis. Phase III enrollment completion of gumokimab (IL-17) for ankylosing spondylitis.

Phase III data readout of gumokimab (IL-17) for Moderate-to-severe psoriasis. Based on this data, an NDA submission for gumokimab (IL-17) for the treatment of moderate-to-severe psoriasis. Potential initiation of a Phase III clinical trial for manfidokimab (IL-4R) for the treatment of moderate atopic dermatitis.

Over the next five years, Akeso has high expectations of launching around 10 internally developed blockbuster drugs, both in China and worldwide, thereby achieving successful commercialization. Akeso has established and continuously advances its integrated and efficient system of discovery, development, production, and sales of its innovative drugs and pipeline candidates.