Annual Review|Annual Highlights of Genuine Biotech in 2025

Genuine Biotech was invited to the New Year Government-Enterprise Exchange Conference Held by the CPC Henan Province Committee and the People's Government of Henan ProvinceSource: Henan News

On February 2, Liu Ning, Secretary of the CPC Henan Province Committee, and Wang Kai, Governor of Henan Province, met with the representatives of private entrepreneurs of Henan in Zhengzhou, listened to their opinions and suggestions, learned about the recent development of enterprises, and sent their best wishes for the Spring Festival to the private sector in the province. Genuine Biotech was invited to participate as a representative of private enterprises.

Genuine Biotech won "BIOCHINA Awards 2024 Innovation Breakthrough Enterprise Award"

On March 19, at the BIOCHINA2025 10th International Convention, the BIOCHINA Awards 2024 List was announced officially. Genuine Biotech won the "2024 Innovation Breakthrough Enterprise Award" for its breakthrough R&D achievements.

Genuine Biotech's independent R&D achievements were listed as "Late-Breaking Research" in AACR Annual Meeting 2025

On April 25, the 116th Annual Meeting of the American Association for Cancer Research (AACR) was held in Chicago. In the conference, the next-generation "small molecule drug" + "novel toxin" dual-platform project independently developed by Genuine Biotech was presented as "Late-Breaking Research".

ZSSW-136, the PCC compound for the small molecule drug in this project, exhibits broad-spectrum antitumor activity and has unique advantages in overcoming resistance to common antitumor drugs. Preclinical studies have shown that its inhibitory activity against irinotecan-resistant tumor cells is 400 times greater than that of irinotecan. In addition, it is expected to be widely used as a novel toxin in various XDC (e.g., ADC, PDC, SMDC, etc.) projects, which is expected to provide a new solution to drug resistance in multiple tumors.

Genuine Biotech initiated phase II clinical trial of Dosimertinib for the treatment of non-small cell lung cancer

In May, Genuine Biotech's phase II clinical trial protocol for its investigational drug Dosimertinib was approved by the Center for Drug Evaluation, National Medical Products Administration, and the first patient was enrolled in June. Results from preclinical studies showed that Dosimertinib reduced potential toxic metabolites by up to 80% compared to Osimertinib, demonstrating a better clinical safety profile. The unchanged drug content of Dosimertinib was higher than that of Osimertinib in lung and brain tissues, suggesting that Dosimertinib is advantageous for the treatment of lung cancer and brain metastases from lung cancer. The results of the phase I trial showed that the overall safety profile of Dosimertinib was favorable and a good dose-related effect was observed.

Genuine Biotech won "2025 China's Top 101 Innovative Pharmaceutical Companies"

CMC-CHINA Expo jointly released - "2025 China's Pharmaceutical Industry TOP101" and the lists of 10 core industry chains. Genuine Biotech won the "2025 China's Top 101 Innovative Pharmaceutical Companies" award for its outstanding innovative strength and R&D achievements.

Azvudine combined with Dosimertinib for the treatment of non-small cell lung cancer was approved for clinical trials

On September 29, the clinical trial of GEN-725 (Azvudine), an antitumor drug independently developed by Genuine Biotech, in combination with Dosimertinib Mesylate was approved by the Center for Drug Evaluation, National Medical Products Administration, to be conducted in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutation.

The results from the non-clinical pharmacological studies showed that the combination regimen produced boosted or synergistic inhibition of tumor growth in mouse xenograft tumor model without any significant increase in toxicity. The in vitro pharmacodynamic results showed that GEN-725 was effective against the primary resistance gene C797S to Osimertinib. Therefore, the combination not only offers potential synergy, but also has the potential to provide continued benefits to patients with locally advanced or metastatic non-small cell lung cancer who have progressed after third-generation EGFR-TKI therapy.

Genuine Biotech submitted files with HKEX for IPO

On November 9, Genuine Biotech Limited submitted its application for listing on the Main Board of the Hong Kong Stock Exchange (HKEX), advancing an important step in the Company's development. Since its establishment in 2012, the Company has been dedicated to the development, manufacturing, and commercialization of innovative drugs for viral infections, tumors, and cardiovascular diseases.

Genuine Biotech's Azvudine was granted phase IIa clinical trial approval for hematological malignancies

In December, the Center for Drug Evaluation of the National Medical Products Administration has granted approval to Henan Genuine Biotech Co., Ltd. to initiate a phase IIa clinical trial of its GEN-725 Tablets (Azvudine), intended for the treatment of hematological malignancies. Following this approval, the Company will further evaluate the safety and preliminary efficacy of Azvudine in patients with hematologic malignancies based on its prior research data.

The safety and efficacy of Azvudine were corroborated by 177 studies

The safety and efficacy of Azvudine, as a new Class 1.1 innovative drug, have been demonstrated by real-world data and 177 papers published by independent third parties in eClinicalMedicine, a series journal of The Lancet, Signal Transduction and Targeted Therapy, a series journal of Nature and the Journal of Medical Virology, among others, confirming the superior safety and efficacy of Azvudine.

Genuine Biotech won "Excellent Biopharmaceutical Company of the Year" Award

On December 22, the "Technology Empowers, Capital Breaks Through" sharing meeting sponsored by GuruClub was successfully held, during which the "Jinge Award" - the list of excellent companies of the year was officially unveiled, and Genuine Biotech won the "Excellent Biopharmaceutical Company of the Year" Award by virtue of its outstanding performance and professional strength in the biopharmaceutical field.

Genuine Biotech won "Most Investment Potential Award"

In Hefei, Anhui Province, China, the "2025 Capital Market Most Valuable Influential List" was unveiled during the conference, and Genuine Biotech won the "Most Investment Potential Award" for its outstanding performance and industry leadership.