November 9, 2024 Source: drugdu 39
"This is our third time participating in the China International Import Expo. Over the past few years, we have leveraged the platform of the expo to share our R&D achievements and business progress, while accelerating the launch of our innovative products in China to benefit more groups as soon as possible. Ultimately, through the expo, we have carried out various collaborations and signed agreements with different partners, thereby speeding up our development process in China," said Jin Fangqian, Gilead Sciences' Global Vice President and General Manager for China, during an interview with media outlets like Times Finance during the 7th China International Import Expo.
At this year's expo, Gilead Sciences announced significant progress regarding its core product, Lenacapavir, in the field of HIV prevention.
Lenacapavir is the world's first approved HIV capsid inhibitor and offers a long-acting treatment regimen needing administration only twice a year. The drug has been approved in the EU and the US for use in combination with other antiretroviral medicines to treat adult patients with multi-drug resistant HIV-1 who have previously undergone various treatment regimens.
In June of this year, Gilead announced that key interim analysis results from the critical Phase 3 PURPOSE 1 trial demonstrated 100% efficacy of Lenacapavir in preventing HIV among cisgender women. Less than three months later, Gilead reported that interim analysis results from the PURPOSE 2 trial showed that 99.9% of participants using Lenacapavir did not contract HIV, representing a 96% reduction in HIV incidence compared to baseline HIV prevalence.
Since its debut at the previous China International Import Expo, Lenacapavir has continuously made new advances in clinical trials over the span of less than a year, potentially revolutionizing HIV prevention strategies. Gilead has submitted a marketing application for Lenacapavir for HIV treatment to China’s drug regulatory authority.
Additionally, Gilead's innovative drug Seladelpar also made its "debut" in China at this expo. This drug received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2024, providing a new second-line treatment option for patients with primary biliary cholangitis. As a chronic autoimmune liver disease characterized by bile duct obstruction, primary biliary cholangitis (PBC) is often overlooked and has been included in the National Health Commission's list of "rare diseases" in 2023.
Moreover, over ten of Gilead’s drugs targeting HIV prevention and treatment, viral hepatitis, oncology, and antifungal areas were showcased at the expo.
Currently, China has become an important component of the global biopharmaceutical landscape, and the Chinese market has become a crucial support for many multinational pharmaceutical companies’ global operations.
Before the expo, Gilead indicated that this year marks the 40th anniversary of the Drug Administration Law. Since the law was enacted in 1984, it has been revised several times, with accelerated approval processes for new drug reviews significantly facilitating the entry of innovative drugs into the Chinese market, allowing multinational companies like Gilead to introduce innovative medicines to meet patient needs more quickly. In 2018 alone, Gilead had five innovative drugs in the hepatitis B, hepatitis C, and HIV treatment areas approved.
Thanks to improved healthcare policies, as of now, eight of the eleven drugs that Gilead has launched in China are included in the National Medical Insurance Directory.
Jin Fangqian stated, "China has always been a very important market for us, and we will continue to increase our investment in China, including new product launches, market expansion, patient access, and R&D development. In the future, we will also conduct more global Phase III clinical trials, as well as earlier Phase II and I trials in China. At the same time, we want to bring more innovative products to China, while also seeking collaborations with local Chinese companies to take Chinese products to the world."
Since 2022, Gilead has begun building local R&D teams and capabilities in China, continuously increasing local R&D investments to push for the simultaneous market launch of innovative medicines both globally and domestically. Currently, Gilead’s R&D team in China has surpassed 150 members and is rapidly advancing approximately 20 clinical research projects within the country. While Gilead continues to invest in drug development, it is also exploring innovative models to enhance drug accessibility.
Faced with rapid changes in the global pharmaceutical market and competitive landscape, maintaining competitive advantage is a key topic for industry players to contemplate. "First, to maintain competitiveness in the market, product innovation is necessary to truly address unmet treatment needs. Second, accelerating the commercialization process is crucial; our strategy is to leverage various partners' strengths to expedite our commercialization process," Jin Fangqian conveyed during the interview at the expo.
https://finance.eastmoney.com/a/202411073232439486.html
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