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LianBio (LIAN) is a pioneering biotechnology company dedicated to accelerating the availability of transformative medicines to patients in China and major Asian markets. The company's mission involves forging partnerships with world-class biopharmaceutical firms to bring paradigm-shifting therapies to historically underserved regions.
Core Business: LianBio focuses on building a diversified portfolio of drug candidates that address significant unmet medical needs. The company's therapeutic focus spans multiple areas, including cardiovascular, oncology, ophthalmology, and inflammatory diseases. They employ a strategy of precision-based therapeutics and transformative mechanisms to impact patient outcomes substantially.
Recent Achievements: LianBio has been making notable strides in clinical development and regulatory milestones. Their product infigratinib, an ATP-competitive FGFR1-3 selective oral tyrosine kinase inhibitor, has shown promising results in a Phase 2 clinical trial for gastric cancer and gastroesophageal junction adenocarcinoma. The study demonstrated a confirmed objective response rate (cORR) of 23.8% and a disease control rate (DCR) of 76.2%, among other encouraging metrics. Infigratinib has received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA).
Current Projects: In addition to infigratinib, LianBio is advancing the clinical development of TP-03, a novel eye drop treatment for Demodex blepharitis. The Phase 3 LIBRA trial demonstrated significant mite eradication, positioning TP-03 for potential regulatory approval in China. The company is also involved in the Phase 1 clinical trial of BBP-398, a SHP2 inhibitor in combination with EGFR inhibitor osimertinib for non-small cell lung cancer (NSCLC) patients.
Financial Condition: For the third quarter of 2023, LianBio reported research and development expenses of $9 million and general and administrative expenses of $17.3 million. The company’s net loss for the same period was $24 million. Despite these expenditures, LianBio maintains a robust cash balance of $252.2 million, ensuring financial stability for ongoing and future projects.
Partnerships: LianBio collaborates with several high-caliber global biopharmaceutical companies, enhancing their capability to bring innovative treatments to market. Notably, they have licensed rights from QED Therapeutics and Tarsus Pharmaceuticals to develop and commercialize breakthrough therapies in China and other Asian territories.
Future Outlook: The company is currently undergoing a strategic review aimed at maximizing shareholder value, including the potential sale of pipeline assets and workforce reductions. LianBio continues to focus on providing access to innovative medicines, leveraging its international infrastructure and strategic partnerships to address critical health needs in the region.
For the latest updates and more detailed information, please visit www.lianbio.com.
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 (p<0.001). 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 China National Medical Products Administration 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.
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