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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.
Nanobiotix has announced significant milestones regarding its pivotal Phase III study, NANORAY-312, for advanced head and neck cancer, aiming for US site activation in Q3 2022. The company has received FDA feedback on a Phase III protocol for NBTXR3 in combination with anti-PD-1 therapy, with submission targeted for Q1 2023. As of March 31, 2022, Nanobiotix reported a cash position of €70.6 million. The company is implementing strategies to reduce operating expenses and has established an equity financing line to extend its financial runway into Q4 2023, while also exploring debt restructuring options.
LianBio (Nasdaq: LIAN) announced key developments, including FDA approval for mavacamten, indicating a commitment to advancing innovative therapies in China. Their partner Tarsus reported positive data for TP-03 in treating Demodex blepharitis, and ReViral entered a definitive acquisition deal with Pfizer. Financially, LianBio's Q1 results showed a net loss of $27.7 million, reduced from $61.6 million year-over-year, while maintaining a cash balance of $389.1 million, ensuring operational funding through mid-2024.
LianBio announced the completion of a Phase 1 pharmacokinetic study of mavacamten in healthy Chinese volunteers, demonstrating a favorable safety and tolerability profile. The study included 44 participants and was conducted in parallel with the ongoing Phase 3 EXPLORER-CN trial focused on treating obstructive hypertrophic cardiomyopathy (oHCM). Positive results from both studies could lead to a New Drug Application submission to China's National Medical Products Administration. Mavacamten previously received Breakthrough Therapy Designation in China and FDA approval in the U.S.
LianBio (Nasdaq: LIAN), a biotechnology company focused on innovative medicines for patients in China and Asia, will participate in the Bank of America Securities 2022 Healthcare Conference from May 10-13, 2022, in Las Vegas. A key event includes a fireside chat on May 12, 2022, at 9:20 a.m. A live audio webcast of this chat will be available on LianBio's investors webpage, with a replay accessible post-event. LianBio aims to enhance healthcare standards across various medical fields through global partnerships, targeting underserved patients in their markets.
Nanobiotix is set to announce its financial results for Q1 2022 on May 18, 2022, after the US market closes. A conference call will follow on May 19, 2022, at 8 AM EDT, where CEO Laurent Levy and CFO Bart Van Rhijn will discuss results and updates on operations. The company, known for its innovative cancer treatment NBTXR3, is advancing clinical studies, particularly in head and neck cancer. NBTXR3 has received Fast Track designation from the FDA, highlighting its potential in oncology.
LianBio (Nasdaq: LIAN) announced that its partner, Tarsus Pharmaceuticals, has successfully met primary and secondary endpoints in the Phase 3 Saturn-2 trial for TP-03, a treatment for Demodex blepharitis. With these positive results, Tarsus plans to submit an NDA to the FDA in the latter half of 2022. LianBio holds rights to develop and commercialize TP-03 in Greater China and plans to initiate a Phase 3 trial to support regulatory approval. Approximately 43 million patients in China suffer from this condition, highlighting a significant market opportunity.
Nanobiotix announced the presentation of three abstracts for its first-in-class radioenhancer NBTXR3 at the 2022 ASCO Annual Meeting from June 3-7. CEO Laurent Levy highlighted the aim to improve cancer patient outcomes by validating NBTXR3's safety and efficacy across various treatments. The accepted abstracts cover clinical trials involving head and neck cancer and rectal cancer. NBTXR3 is designed to induce significant tumor cell death when activated by radiotherapy and is currently under evaluation for several indications.
LianBio (Nasdaq: LIAN) announces the continued development of Camzyos in China and other Asian markets following FDA approval for treating symptomatic obstructive hypertrophic cardiomyopathy (HCM). Licensed from Bristol Myers Squibb, Camzyos is the first FDA-approved drug targeting the pathophysiology of obstructive HCM. LianBio's Phase 3 study, EXPLORER-CN, aims to evaluate mavacamten's efficacy in Chinese patients, addressing a significant unmet need as approximately 1.1 to 2.8 million patients are affected by HCM in China.
LianBio has established a Scientific Advisory Board to enhance its development of innovative therapeutics in Greater China and Asia. This board includes esteemed industry leaders who will serve as strategic advisors, aiding in program strategy and business development. Key members include Mathias Hukkelhoven, an expert in regulatory affairs, Elliott Levy, a veteran in clinical development, and Zhao Yan, an authority in drug development in China. CEO Yizhe Wang expressed pride in the board's formation, expecting valuable insights to advance LianBio’s clinical pipeline.
Nanobiotix announced new preclinical data at the 2022 American Association of Cancer Research meeting, showcasing the effectiveness of NBTXR3 in combination with anti-PD-1, anti-LAG-3, and anti-TIGIT therapies. The study indicated that this combination therapy significantly enhanced immune activation, longevity in anti-cancer memory, and overall survival in mice. This suggests potential effectiveness against metastatic cancers, indicating a promising avenue for future clinical applications.