Good News | Genuine Biotech Wins "BIOCHINA Awards 2024 Innovation Breakthrough Enterprise Award"

Recently, at the BIOCHINA 2025 10th International Convention, the BIOCHINA Awards 2024 List was announced. Genuine Biotech, with its breakthrough R&D achievements, won the "2024 Innovation Breakthrough Enterprise Award". The BIOCHINA Convention has been consistently focusing on the innovation and transformation in bio-industry. Based on the focus on innovative drugs, it promotes the communication and sharing of cutting-edge development experience of the whole industry chain, such as scientific research achievements, clinical needs, industrial transformation, and business expansion.

As a biotech company driven by innovation, Genuine Biotech consistently prioritizes "innovative research and development" in its growth. In 2024, Genuine Biotech has made breakthroughs in several blockbuster R&D projects: In the antiviral field, the company accelerated the clinical progress of CL-197, a next-generation oral long-acting HIV drug candidate. The Phase I clinical trial for CL-197 was commenced in August 2023. As of February 2025, the clinical trials on all the 44 patients enrolled had been completed, and the company was analyzing the data collected. Given that both Azvudine and CL-197 have demonstrated long-acting features in preclinical trials, the company plans to develop an all-oral long-acting composite tablet, which shows the potential to become the global first all-oral, long-acting and weekly administered treatment for HIV through the combined action on three targets. In the anti-tumor field, the company obtained an IND approval from the NMPA for the clinical trials of Azvudine in patients with advanced solid tumors in September 2024, and the clinical trial of monotherapy in patients with advanced solid tumors was approved. In November 2024, The company submitted IND application for the combination therapy of Azvudine and dosimertinib for the treatment of NSCLC.

Preclinical data indicates that Azvudine has unique anti-tumor mechanism. It can exert its anti-tumor effects by inhibiting DNA synthesis in tumor cells and enhancing immunity through immunomodulation:

- Azvudine/anti-PD-1 combination therapy for the treatment of liver and colorectal cancer, where 100% tumor remission was observed in animal studies;

-In an investigatorinitiated trial(IIT) , 100% of NSCLC patients who progressed after last-line treatment achieving effective disease control;

- Azvudine/dosimertinib combination therapy for the treatment of NSCLC, demonstrating a 92.82% tumor inhibition rate in animal models;

- Azvudine monotherapy and azvudine/CTX combination therapy for blood cancer, where single-agent treatment showed a significant inhibitory effect on blood tumors and combination treatment achieved 100% tumor remission in animal studies.

In addition to expanding the anti-tumor indications and combination therapies of Azvudine, Genuine Biotech has been also actively advancing the dual-platform project of next-generation "small molecule drug" + "novel toxin" (project code: ZS-1003). Utilizing an AI-Computer Assisted Drug Design (CADD) approach, the research team break through the structural limitations of traditional camptothecin drugs, modifying the core nucleus of camptothecin, which led to discover hundreds of novel TOPO1 inhibitor molecules with new structures and multiple candidate compounds with the properties of a new generation of payloads with strong global IP protection positions. Currently, the discovery of the first small-molecule PCC compound under ZS-1003 project has been completed, namely ZSSW-136. This PCC molecule demonstrates broad-spectrum antitumor activity and has unique advantages in overcoming resistance to common anti-tumor drugs. Preclinical studies have demonstrated that it showed significant anti-tumor effects, with an inhibitory activity against Irinotecan-resistant tumor cells 400 times as high as that of irinotecan. It is also expected to been applied in various XDC (e.g., ADC, PDC, and SMDC) R&D projects to provide effective solutions for various drug-resistant tumors. The new generation of payloads can overcome drug resistance, and are comparable in anti-tumor activity to commonly used ADC payloads (e.g. SN-38, DXd, and other camptothecin-based compounds), but with much improved druggability (e.g. membrane permeability, nonexocytosis, etc.). The company has discovered numerous payload candidates with more than 50-fold higher potency compared to DXD in the DXD-resistant cancer cell lines.

This award highly recognizes the innovative value and development potential of Genuine Biotech.Looking to the future, Genuine Biotech will remain committed to pursuing innovation-driven research, attracting global talents, advancing core technological breakthroughs, and expediting drug development, with the aim to rapidly evolve into a globally competitive biopharmaceutical leader!