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LianBio (Nasdaq: LIAN) announced positive topline results from the Phase 3 EXPLORER-CN trial for mavacamten, aimed at treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in Chinese patients. The trial met its primary endpoint, showcasing a statistically significant reduction in the Valsalva left ventricular outflow tract (LVOT) gradient (p0.001). All secondary endpoints also showed significant improvement, with no new safety concerns reported. Mavacamten could become the first cardiac myosin inhibitor approved in China for oHCM treatment. An NDA with Priority Review was accepted by the in April 2023, based on the positive outcomes of both EXPLORER-CN and the global EXPLORER-HCM trial.
LianBio (Nasdaq: LIAN) has announced the promotion of Pascal Qian to Chief Commercial Officer while retaining his position as China General Manager. This move comes as the company prepares for the potential approval and launch of mavacamten in China by 2024. Yizhe Wang, CEO of LianBio, expressed confidence in Qian’s ability to enhance the company’s commercial capabilities, citing his extensive experience in the biopharmaceutical sector. Qian, who has over 25 years of experience, has a successful track record in launching various drugs in China. The company aims to leverage his expertise to strengthen its operations ahead of entering the commercial market. LianBio is focused on delivering transformative medicines to underrepresented patients across Asia, aiming to establish itself as a key player in the region.
LianBio (Nasdaq: LIAN) announced that China’s National Medical Products Administration (NMPA) has prioritized the review of its New Drug Application (NDA) for mavacamten, aimed at treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults. This regulatory acceptance allows the company to potentially provide a first-in-class treatment in China. CEO Yizhe Wang highlighted the company’s strong clinical data and commitment to patient access. The NDA is founded on results from the global Phase 3 EXPLORER-HCM trial, demonstrating significant improvements in exercise capacity and heart function. Additionally, data from a Phase 1 study in healthy volunteers support the NDA's safety profile. Mavacamten is already FDA-approved and has received Breakthrough Therapy Designation in China.
LianBio (Nasdaq: LIAN) reported its financial results for Q4 and the full year 2022, highlighting a net loss of $18.3 million for Q4, down from $21.2 million a year earlier, with an annual loss of $110.3 million versus $196.3 million in 2021. The company has cash and equivalents totaling $302.4 million, providing a runway through 2024. Key developments include ongoing Phase 3 trials for mavacamten in obstructive hypertrophic cardiomyopathy and TP-03 for Demodex blepharitis, with data expected in mid and late 2023. A commercial agreement with Pfizer for the RSV candidate sisunatovir was also established, with LianBio receiving an upfront payment of $20 million.
Pfizer has assumed development rights for sisunatovir, an RSV therapeutic candidate, in Greater China and Singapore as part of a strategic collaboration with LianBio. This decision comes with a $20 million upfront payment and potential milestone payments up to $135 million. LianBio is now eligible for a share of net sales. Sisunatovir aims to address RSV-related health issues affecting over 400,000 pediatric and elderly patients in China annually. The collaboration emphasizes expanding access to innovative treatments for severe RSV cases.
LianBio (Nasdaq: LIAN) announces the resignation of Debra Yu, M.D., President and Chief Strategy Officer, effective January 1, 2023. Dr. Yu, a founding member since 2019, will consult for LianBio until June 30, 2023. LianBio's CEO, Yizhe Wang, expressed gratitude for her contributions, highlighting the foundation she built for the company's future success in bringing innovative medicines to patients in China and Asia. LianBio focuses on developing clinically validated treatments across several therapeutic areas.