Hasten Biopharma Co., Ltd.

- Application based on integrated global data dossier completed for Lerodalcibep by LIB - Hasten to begin bridging studies to support planned BLA submission in China CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories. The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten. “We are excited for Hasten to begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy,” said David Cory, Chief Executive Officer of LIB. “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA. Lerodalcibep has a potential best in class LDL-C lowering pro will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel.” About Lerodalcibep Lerodalcibep is a potential best in class, novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for submission to the Food and Drug Administration followed by a marketing authorization application (MAA) for submission to the European Medicines Agency. About Hasten Biopharmaceutical Company, Ltd. Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value. About LIB Therapeutics, Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. For more information, please visit: .

The deal also lends a bit of insight into Exelixis’ business strategy after Farallon Capital Management’s activist play earlier this year. Fresh off a vitriolic activist battle that spurred the ouster of three board members, Exelixis plans to hydrate its pipeline with artificial intelligence.  The company, known for solid tumor med Cabometyx, is licensing a phase 1 small molecule from Insilico Medicine for $80 million in addition to undisclosed milestone payments, according to Tuesday announcement. The deal gives Exelixis worldwide rights to a cancer treatment targeting USP1 called ISM3091, which Insilico says may have particular value in BCMA-mutated tumors.  It's the third clinical-stage asset born out of Insilico’s AI discovery and development engine, Chemistry42, which uses machine learning for drug discovery. Insilico has touted that platform as rapidly accelerating the entire early R&D process, reporting that it took 30 months from the starting line to a phase 1 trial for its lead asset. ISM3091 just launched in the clinic less than a month ago. The deal also lends a bit of insight into Exelexis’ business strategy after Farallon Capital Management’s activist play earlier this year. The shareholder accused the company of wasting R&D capital with little to show for it and said more resources should have been funneled toward expanding Cabometyx. All three of the board members targeted by Farallon have been replaced.  Elsewhere in the biotech universe, Cincinnati-based biotech LIB Therapeutics has offloaded greater China licensing rights to late-stage PCSK9 inhibitor lerodalcibep. Hasten Biopharmaceutical Company is scooping up the regional responsibilities in exchange for $20 million in upfront cash, $305 million in potential biobucks and potential royalties.  LIB is cashing in a couple of weeks after nailing a second phase 3 victory for lerodalcibep, finding that the med reduced LDL-C levels in patients with heterozygous familial hypercholesterolemia by almost 60% compared to the placebo group. The company is awaiting data from two more late-stage trials. Hasten will assume all development and commercialization duties in the region, which covers China, Taiwan, Macau and Hong Kong. The biotech is expected to submit a new drug application to Chinese regulators before the end of the year and launch a phase 3 trial in patients with hypercholesterolemia shortly thereafter. 

-- LIB Therapeutics to receive up to $325 million in upfront and milestone payments in addition to royalties -- Hasten obtains rights to develop and commercialize lerodalcibep in Chinese Mainland, Hong Kong, Macau, and Taiwan and will be responsible for clinical development and regulatory approval in these territories CINCINNATI & SHANGHAI--(BUSINESS WIRE)-- LIB Therapeutics Inc. (“LIB”) and Hasten Biopharmaceutical Co., Ltd. (“Hasten”), today announce that the companies have entered into an agreement granting Hasten the rights to develop and commercialize lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan). LIB is a late-stage, biopharmaceutical company developing lerodalcibep for patients at very high and high-risk of cardiovascular disease (CVD). Lerodalcibep is a next-generation, PCSK9 inhibitor in development to potentially overcome the limitations of current low-density lipoprotein (LDL-C), or ‘bad’ cholesterol, lowering treatments to achieve the new national and international guidelines to treat and prevent CVD. The convenient, small-injection volume, monthly dosing and long-ambient stability combined with excellent and sustained LDL-C efficacy of lerodalcibep, if approved, will increase the treatment options for patients, including the 30 million individuals with more severe inherited high-cholesterol, called familial hypercholesterolemia (FH). In late August, LIB reported the global Phase 3 LIBerate-HeFH trial results of lerodalcibep in patients with heterozygous familial hypercholesterolemia (He-FH) who are very high or high-risk for CVD. These results, presented at the 2023 European Society of Cardiology (ESC) Annual Conference, demonstrated that both co-primary endpoints of LDL-C lowering were achieved. The trial enrolled 478 patients with He-FH, which effects about 1 in 300 people in China. After adjusting for placebo effect, monthly lerodalcibep resulted in placebo-adjusted reductions of mean LDL-C in the intent-to-treat population of 58.6% at Week 24 (p<0.0001) and 65.0% at the mean of Week 22 and 24 (p<0.0001). 68% of subjects on lerodalcibep achieved both a reduction in LDL-C of ≥50% and the recommended 2019 ESC LDL-C targets compared to 1.9% on placebo. Favorable tolerability and safety were observed with treatment-emergent adverse events which were generally similar between lerodalcibep and placebo. “LIB is extremely pleased to partner with Hasten, a rapidly growing biopharmaceutical company in China with a focus on cardiovascular and metabolic care,” said Evan Stein, MD, PhD, Chief Operating and Chief Scientific Officer of LIB Therapeutics. “We believe that Hasten, and their experienced, knowledgeable, and motivated team of pharma professionals, is the optimal partner to bring our third-generation PCSK9 inhibitor, lerodalcibep, to the large and growing Chinese population with very-high and high risk for CVD, who need substantial additional LDL-cholesterol reductions, despite statin therapy.” “Our collaboration with LIB is a significant milestone for Hasten, which marks a breakthrough in expanding and diversifying our portfolio in the field of chronic cardiovascular disease,” said Summer Xia, Chief Executive Officer of Hasten. “Furthermore, it also reflects Hasten's determination to build the research and development pipeline as well as reinforce the business strategy. Lerodalcibep is a highly promising product that will better enable Hasten to fulfill its commitment of creating value for the health of society through providing innovative products and solutions to address the unmet needs of patients. We look forward to working with LIB to bring lerodalcibep to patients in Greater China as soon as possible.” Under the terms of the agreement, LIB has granted Hasten the exclusive rights to develop and commercialize lerodalcibep in Greater China. In return, LIB will receive an upfront payment of $20 million. LIB is eligible to receive future milestone payments of up to $305 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones. LIB is also entitled to royalties as a percentage of net sales in Greater China. Hasten will be responsible for clinical development, regulatory and commercialization in Greater China. A joint steering committee will be established to ensure alignment of lerodalcibep’s development in Greater China with LIB’s overall global development and commercialization strategy. Hasten intends to submit an Investigational New Drug (IND) application to the China National Medical Products Administration (NMPA) at the end of this year and begin Phase 3 clinical trials for hypercholesterolemia treatment in Greater China thereafter and anticipates launching this drug in China as early as possible. About Lerodalcibep Lerodalcibep is a next-generation, PCSK9 inhibitor in development to potentially overcome the limitations of current low-density lipoprotein (LDL-C), or ‘bad’ cholesterol, lowering treatments to achieve new national and international guidelines to treat and prevent cardiovascular disease (CVD). The convenient, small-injection volume, monthly dosing and long-ambient stability combined with excellent and sustained LDL-C efficacy of lerodalcibep, if approved, will increase the treatment options for patients, including the 30 million individuals with more severe inherited high-cholesterol, called familial hypercholesterolemia (FH). LIB Therapeutics expects to submit a biologics license application (BLA) with FDA in Q1 2024 and marketing authorization application (MAA) with EMA in Q2 2024. About Phase 3 LIBerate Program LIBerate is a large, comprehensive global Phase 3 program composed of 5 key studies with lerodalcibep in over 2,500 patients in patients with cardiovascular (CVD), very high and high-risk for CVD, heterozygous familial hypercholesterolemia (He-FH) and homozygous FH (Ho-FH). The Phase 3 studies LIBerate-HoFH (LIB-003-003, n=65) and LIBerate-HeFH (LIB-003-004, n=479) have completed and met their primary endpoints. The final two Phase 3 pivotal trials, LIBerate-CVD (LIB-003-005, n=923) and LIBerate-HR (LIB-003-006, n=923), added to maximally tolerated oral lipid-lowering therapies to assess LDL-lowering in CVD, very high and high-risk for CVD patients are anticipated to complete in early November. About LIB Therapeutics LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease, and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. About Hasten Biopharmaceutical Company Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value.