Multiple Innovative Drugs Achieve Phase III Clinical Success, Poised for Value Realization

　　【Pharmaceutical Network Product InformationRecently, there has been a series of positive developments in China's innovative drug sector. Companies such as Laekna Therapeutics, Zelgen, and Alphamab Oncology have successively announced the successful completion of Phase III trials for their core products. These achievements are expected to bring new treatment options to patients and also demonstrate the R&D strength of China-produced innovative drugs, with clinical value soon to be realized.
 

Among them, Laekna Therapeutics announced on April 15 that the Phase III clinical trial (AFFIRM-205) of Afuresertib (LAE002) in combination with fulvestrant for the treatment of HR+/HER2- breast cancer successfully reached its primary endpoint – progression-free survival (PFS) was significantly prolonged in the Afuresertib group compared to the control group.
 

LAE002 is a potent AKT inhibitor that can simultaneously inhibit all three AKT subtypes (AKT1, AKT2, and AKT3). It is also one of only two AKT inhibitors globally in late-stage clinical development for breast cancer and prostate cancer. Study results showed that the primary endpoint was met, with a median PFS of 7.6 months in the LAE002 plus fulvestrant group compared to 2.0 months in the placebo plus fulvestrant group, with an HR of 0.33 (p<0.0001). In terms of safety, patients treated with once-daily oral LAE002 demonstrated good tolerability, with a very low rate of treatment discontinuation due to adverse events. The overall safety profile was consistent with prior data evaluating this combination therapy.
 

Based on the positive results of this pivotal Phase III study, Laekna Therapeutics and Qilu Pharmaceutical will submit a New Drug Application (NDA) for LAE002 to the CDE in the near future. It is reported that Laekna Therapeutics signed an exclusive licensing agreement with Qilu Pharmaceutical in November 2025, granting Qilu Pharmaceutical the exclusive rights to research, develop, and commercialize LAE002 in China, with a total amount of up to 2.045 billion yuan.
 

Zelgen announced on April 13 that the multi-center, randomized, double-blind, placebo-controlled phase III clinical trial (Protocol No.: ZGJAK025) of its self-developed Class 1 new drug, Jaktinib Hydrochloride Tablets (formerly known as: Jakinib Hydrochloride Tablets), for the treatment of adult patients with moderate to severe atopic dermatitis, has reached the primary efficacy endpoint with statistical significance (p<0.0001). The company will accelerate the marketing process for the indication of Jaktinib Hydrochloride Tablets in treating patients with moderate to severe atopic dermatitis.
 

On March 31, Alphamab Oncology also announced that the Phase III clinical study (study code: KN026-004) of KN026 in combination with injectable docetaxel (albumin-bound type) (HB1801), developed in collaboration with Jimantuxi Biologics, a subsidiary of CSPC Group, for neoadjuvant treatment of HER2-positive breast cancer (BC), has reached the pre-specified primary endpoint of total pathological complete response rate (tpCR). The results are statistically significant and clinically meaningful. KN026 is a HER2 bispecific antibody developed by Alphamab Oncology using its proprietary Fc heterodimer platform technology (CRIB). It can simultaneously bind to two non-overlapping epitopes of HER2, blocking HER2 signaling. Through antibody-induced receptor clustering, it enhances ADCC and CDC effects while downregulating HER2 receptors on the cell surface.
 

Three Innovative Drugs Achieve Breakthrough Results in Phase III Clinical Trials Successively, Which Will Not Only Bring Better Treatment Options to Patients in China but Also Reflect the Core Progress of Innovative Drug Development in China. Over the Past Decade, the Innovative Drug Industry in China Has Undergone a Transformation from "Combination of Imitation and Innovation" to "Independent Innovation," with an Increasing Number of Pharmaceutical Companies Focusing on Cutting-edge Targets and Mechanisms. As LAE002, Jigacitinib Hydrochloride, and KN026 Gradually Advance in Their Regulatory Applications, the Future May See the Launch of Several Significant Innovative Drugs in China.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.