We are already participating in the CIIE for the third time. In the past few years, with the platform of the CIIE, we have been able to share our research and development achievements and business progress, while also accelerating the launch of our innovative products in China, benefiting more groups as soon as possible. Finally, we have also carried out multi-party cooperation through the CIIE platform, signed contracts with various partners, and accelerated our development process in China. "During the 7th CIIE, Jin Fangqian, Global Vice President and General Manager of Gilead Science in China, said in an interview with media such as Times Finance.
At this year's CIIE, Gilead Science announced for the first time the significant progress of its core product Lenacapavir in the field of HIV prevention.
Lenacapavir is the world's first approved HIV capsid inhibitor drug and a long-acting HIV treatment regimen that only requires two doses per year. The drug has been approved in the European Union and the United States for use in combination with other antiretroviral drugs to treat multidrug-resistant HIV-1 adults who have previously received multiple treatment regimens.
In June this year, Gilead announced that the interim analysis results of Lenacapavir's key phase 3 PURPOSE 1 showed that the drug showed 100% effectiveness in HIV (AIDS) prevention among transgender women; Less than three months later, Gilead once again stated to the public that the mid-term analysis results of PURPOSSE 2 showed that 99.9% of subjects using Lenacapavir did not develop HIV infection. Compared to the background HIV incidence rate (bHIV), Lenacapavir reduced the HIV infection rate by 96%.
Since its debut at the CIIE last year, in less than a year, Lenacapavir has made continuous progress in clinical trials, which may revolutionize HIV prevention plans. According to Gilead, Gilead has submitted a marketing application for Lenacapavir for HIV treatment to the Chinese drug review department.
Gilead's innovative drug Seladelar also made its debut in China at this year's CIIE. The drug received accelerated approval from the US Food and Drug Administration (FDA) in August 2024, providing a new option for second-line treatment of patients with primary biliary cholangitis. As a chronic autoimmune intrahepatic cholestasis disease, primary biliary cholangitis (PBC) is an easily overlooked "hidden killer" of the liver, and has been included in the "Second Batch of Rare Diseases" catalog released by the National Health Commission in 2023.
In addition, over 10 drugs from Gilead in the fields of HIV prevention and treatment, viral hepatitis, oncology, and antifungal therapy are also exhibited at the CIIE.
At present, China has become an important part of the global biopharmaceutical industry, and the Chinese market has become one of the important pillars of global business for many multinational pharmaceutical companies.
Gilead told Time Finance before this year's CIIE that this year marks the 40th anniversary of the Drug Administration Law. Since its promulgation in 1984, the Drug Administration Law has undergone several revisions and developments, among which the accelerated review and approval of new drugs has provided great convenience for innovative drugs to enter the Chinese market, enabling multinational pharmaceutical companies like Gilead to quickly introduce innovative drugs into China and meet the treatment needs of patients. In 2018 alone, Gilead had five innovative drugs approved in the field of chronic hepatitis B B, hepatitis C and HIV treatment.
Thanks to the improvement of medical insurance policies, as of now, 8 out of the 11 drugs listed by Gilead in China have been included in the national medical insurance catalog.
Jin Fangqian told Time Finance, "China has always been a very important market for us, and we will continue to increase our investment in China, including the launch of new products, expansion of market coverage, patient benefits, research and development, etc. In the future, we will also carry out more global Phase III clinical trials, and even earlier Phase II and I clinical trials in China. At the same time, on the one hand, we hope to bring more innovative products to China, and on the other hand, we also hope to cooperate with local Chinese enterprises to bring Chinese products to the world
Starting from 2022, Gilead will establish a local R&D team and capabilities in China, continuously increasing investment in local R&D and promoting the simultaneous launch of innovative drugs globally and domestically. As of now, the R&D team of Gilead China has exceeded 150 people, promoting the rapid development of about 20 clinical research projects in China. While Gilead continues to invest in drug research and development, it is also constantly exploring innovative models to help improve drug accessibility.
Facing the rapid changes in the global pharmaceutical market and competitive environment, how to maintain competitiveness is a proposition that major players need to consider. Firstly, in order to maintain competitiveness in the market, product innovation is needed to truly address some unmet treatment needs. Secondly, we must accelerate the commercialization process. Our logic is to leverage the power of various partners to accelerate our commercialization process, "Jin Fangqian said to Time Finance during the CIIE.