Key Events in 2024
2025-01-22
1. Human Urine-Derived Protein
Acquisition of Control Rights in NanDa Pharma to Lay Out the Second Growth Curve
Aidea Pharma has achieved substantial progress in the "human urine-derived protein raw material & formulation integration" strategy by acquiring control rights in NanDa Pharma, which further solidifies the dual-engine strategy and lays out the second growth curve. Both parties will fully leverage industrial synergies to achieve mutual benefits and win-win outcomes, bringing a positive impact on the company's development.
2. Anti-HIV Innovative Drugs
Approval of New Indication Application of Ainuomiti
In October 2024, Aidea Pharma received the "Drug Registration Certificate" issued by the National Medical Products Administration (NMPA), marking the approval of the registration for the new indication of Ainuomiti. After that, Aitribond® can be used for both treatment-naïve and virologically-suppressed people with HIV-1 (PWH).
Ainuovirine API Receives Approval and Commences Commercial Production
In June 2024, Aidea Pharma received the "Chemical Raw Material Drug Marketing Application Approval Notice" for Ainuovirine from the National Medical Products Administration (NMPA). On the morning of June 18th, a grand launch ceremony for Ainuovirine API production was held in the Yangzhou High-Tech Zone.
Chengdu Aidea Grandly Opens to Accelerate the Expansion of R&D Pipeline
To expand anti-HIV drugs R&D pipeline, Aidea Pharma established Chengdu Aidea Pharma Tech Co., Ltd as a wholly-owned subsidiary in September 2023, to develop the new integrase inhibitor ACC017 and its combination formulations. On January 25, 2024, Chengdu Aidea grandly opened for business,and this grants Aidea Pharma an opportunity to continuously expand its in-depth layout in the HIV field and keep strengthening the development of innovative anti-HIV drugs.
ACC017 Tablet Phase Ib/IIa Clinical Trial Launched
On August 23, 2024, the launch meeting for the Phase Ib/IIa clinical trial of the anti-HIV Class 1 new drug ACC017 tablet was successfully held at the Beijing Ditan Hospital Capital Medical University. The first participant completed the signing of the informed consent form on August 28th and the enrollment of the first participant completed on September 2nd, marked the entry of the ACC017 tablet clinical trial into a new phase.
3. Academic Exchanges
Aidea Pharma's Two Innovative Drugs Included in the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS (2024 Edition)
Aidea Pharma's two innovative drugs, Ainuovirine and Ainuomiti Tablets, were included in the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS (2024 edition). Ainuomiti is recommended as an A1 level of the Preferred Regimen for Initial Treatment of Adults and Adolescents with HIV—STR, which not only recognize the therapeutic value of Ainuovirine and Ainuomiti Tablets, but also highlight the great market potential for those two innovative drugs.
Phase III SPRINT Study on Ainuomiti Published in the Top International Journal The Lancet Regional Health–Western Pacific
In July 2024, the data of Phase III clinical trial of Ainuomiti (Ainuovirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, ANV/3TC/TDF) was published online in full by The Lancet Regional Health - Western Pacific, an authoritative international medical journal. This is also the first domestic oral anti-HIV innovative drug to be published in the top international clinical medical journal, and the evidence of China's anti-HIV evidence-based medicine has once again been recognized by international counterparts.
Aidea Pharma's Two Anti-HIV Innovative Drugs Shine at International Academic Stage
From June to November 2024, Aidea attended five top international conferences on AIDS clinical science, including the APACC (Hong Kong, China), the AIDS 2024 (Munich, Germany), the IWCPHHOAD Liverpool 2024 (Liverpool, UK), the IDWeek (Los Angeles, USA), and the HIV Glasgow 2024 (Glasgow, UK). A total of 28 research abstracts were selected for academic sharing at the conferences, among which two studies—the Phase III SPRINT study on switching to Ainuomiti and the clinical pharmacology series of Ainuovirine—were invited to give oral presentations without sponsorship.
Real-World Studies from "iStudy" Published in Multiple International Medical Journals
Five real-world studies from the "iStudy" program have been published in several international medical journals. These studies confirmed that the ANV-based Regimen is comparable to the current first-line Efavirenz-based regimen in China, with advantages in blood lipids, nervous system safety and other safety aspects, bringing real benefits to the majority of PLWH.
Chairman Dr. Heliang Fu Attends the 9th National AIDS Academic Conference
On April 27, 2024, Aidea Pharma’s chairman, Dr. Heliang Fu was invited to attend the 9th National AIDS Academic Conference and delivered a report titled "Introduction to the Pipeline of Innovative AIDS Drugs | The Twin Stars of Domestic Anti-AIDS Innovation —— Ainouvirine and Ainuomiti Tablets". Ainuovirine/Ainuomiti Tablets have ample clinical evidence and are widely recognized in society. Aidea Pharma will collaborate with various sectors to continue R&D and commit to taking "Made in China" to benefit the worldwide PLWH.
4. International Layout
Chairman Dr. Heliang Fu Leads Delegation to Visit Namibia and Receives Warm Welcome from President Mbumba
On May 21, 2024, local time, Dr. Heliang Fu, Chairman of Aidea Pharma, led a delegation to visit Namibia. Two sides held talks at the Presidential Palace. President Mbumba extended a warm welcome to Chairman Fu and Aidea delegation, and expressed that the Namibian government will provide a superior environment and comprehensive support for the development of Aidea Pharma in Namibia.
Aidea Pharma Enters into Strategic Cooperation with CADFund, PharmaBlock and Fidson Healthcare
On September 4, 2024, Jiangsu Aidea Pharmaceutical Co., Ltd., China-Africa Development Fund (CADFund), PharmaBlock Sciences (Nanjing) Inc., and Fidson Healthcare Plc signed the Memorandum of Understanding Relating to the Project of New Pharmaceutical Plant in Nigeria in Beijing. The parties agreed to establish a strategic cooperation relationship, jointly explore investment opportunities in the pharmaceutical markets of West African countries, and implement investment cooperation at the project level.
5. Honors
Aidea Pharma Selected as a National "Little Giants" Enterprise
On September 2, 2024, Industry and Information Technology Department of Jiangsu announced the sixth batch of national "Little Giants" enterprises, with Aidea Pharma making the list. “Little Giants” enterprises concentrate on markets segment, have strong innovation capabilities, share high market, master the core technology, and have excellent quality and efficiency.
Aidea Pharma Receives the Second Prize of the 2023 Jiangsu Province Sci & Tech Awards
On November 7, 2024, the project "Development and Industrialization of the National Class 1 Anti-HIV New Drug Ainuovirine Tablet" , jointly completed by Aidea Pharma and Beijing You'an Hospital Capital Medical University, was awarded the Second Prize of the 2023 Jiangsu Province Science and Technology Award, which is the highest award in the field of science and technology in Jiangsu Province.
Aidea Pharma Receives High-Tech Enterprise Certification Again
On February 21, 2024, Aidea Pharma was once again recognized as a national high-tech enterprise by Jiangsu Provincial Departments. This signifies Aidea Pharma's authoritative recognition in independent R&D capabilities, technology achievement transformation, and core independent intellectual property rights.
Four Consecutive Years in the "Top 30 Innovative Small Molecule Drug Companies in China" Ranking List
In June, the "2023 China Biopharma Companies Innovation Top 100 Series List" was released at the 2024 MHIS Conference. Aidea Pharma, with its outstanding contributions in the field of HIV innovative drugs, has been selected for the "Top 30 Innovative Small Molecule Drug Companies in China" for four consecutive years.
Aidea Pharma Selected as the 2024 Great Health Industry Outstanding Enterprise in the Yangtze River Delta
After recommendations from various cities in the Yangtze River Delta region and evaluation by the Health Service Industry Committee of the Yangtze River Delta City Economic Coordination Association, Aidea Pharma was honored as the "2024 Great Health Industry Outstanding Enterprise in the Yangtze River Delta."
Aidea Pharma Selected as One of Top 20 Yangzhou Innovative Private Enterprises in 2023
In February, Aidea Pharma was awarded the titles of "Top 20 Yangzhou Innovative Private Enterprise in 2023" and "Meritorious Enterprise Third Prize in 2023." These honors not only affirm the hard work of Aidea Pharma but also highly recognize its outstanding contributions to promoting local economic construction and development.
Explanatory Notes
About Ainuovirine Tablets and Ainuomiti Tablets
Ainuovirine Tablets were approved for marketing in June 2021 and are the first original oral new drug for the HIV-1 treatment in China. Ainuomiti Tablets, a combination of ainuovirine, lamivudine and tenofovir disoproxil fumarate, were approved for marketing in December 2022 and are the first three-in-one single-tablet combination anti-HIV/AIDS new drug with independent intellectual property rights in China.
About SPRINT Study on Ainuomiti Tablets
The SPRINT study is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority study to evaluate the efficacy and safety of Ainuomiti Tablets (ANV/3TC/TDF) versus Genvoya® (EVG/Cobi/FTC/TAF) in virologically suppressed PLWH. A total of 762 participants who had been treated with a NNRTI combined with two NRTIs for at least 12 months were randomly assigned (1:1) to receive Ainuomiti Tablets or Genvoya® for up to 48 successive weeks, followed by an optional open-label extension period with 48-week Ainuomiti treatment.