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Week in Review: Hengrui Launches US Subsidiary to Bring Novel Medicines to Global Markets
Deals and Financings
Jiangsu Hengrui Pharma (SHA: 600275) launched a new global company, Luzsana Biotechnology, devoted to making the most advanced medications available and affordable in global markets (see story). For 25 years, Hengrui has been developing novel drugs, with a portfolio of 250 clinical studies for unmet needs in oncology, cardiovascular, metabolic/diabetes, pain management, immunology and liver/renal disease. Initially, the company will co-develop 11 of Hengrui’s candidates (eight of them for oncology) that range from preclinical to Phase III stage. All the candidates have first-in-class or best-in-class potential, the company said. Luzsana is headquartered in Princeton, NJ with facilities in Basel and Tokyo.
Sichuan Kelun Pharmaceutical out-licensed global rights (ex-China) for a large molecule candidate to Merck in a deal worth nearly $1.4 billion (see story). Kelun will receive $47 million in upfront payments and up to $1.36 billion in milestones. Although the candidate was not identified, it is expected to be SKB264, a third-gen TROP2-targeting antibody-drug conjugate in Phase II trials in the US and China. The candidate is being developed by KLUS Pharma, Kelun’s New Jersey-based novel drug developing subsidiary. Merck is known as MSD outside of North America.
Shanghai Laekna Therapeutics raised $61 million in a Series D financing for its next-gen cancer and liver disease medicines (see story). Founded in 2017, the company has built a portfolio that consists of 14 novel drug candidates, including six clinical programs, three of which are multi-regional clinical trials (including one pivotal trial). Laekna has acquired at least four drug candidates from Novartis: an androgen inhibitor in 2017; two Akt inhibitors in 2018; and an anti-PD-1 antibody in 2020. The company’s latest funding was led by CS Capital and joined by Worldstar and Infinity Capital.
Shanghai Henlius Biotech (HK: 2696) signed a $55 million agreement to out-license rights for three biosimilar drugs in 16 Latin America countries to Eurofarma, a Brazil pharma (see story). Eurofarma will have rights to market the three biosimilars to drugs that were originally developed by Genentech: Rituxan (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab). Previously, Henlius had out-licensed rights to some of the drugs in other South American countries, as it has for major markets around the world. Henlius develops biosimilars, bio-betters and novel biologic candidates.
Trials and Approvals
Shanghai Belief Biomed reported that positive results from an investigator-led clinical trial of its gene therapy for hemophilia B were published in The Lancet Haematology (see story). In ten patients with moderate to severe hemophilia., there were no bleeding incidents during more than a year of follow-up after a one-time treatment with BBM-H901. The therapy was effective within 24 hours and did not cause significant side effects. Belief Bio said the trial was the first intravenously injectable hemophilia B gene therapy product developed and tested in Asia.
Inmagene, a Shanghai-San Diego biopharma, was approved to start a Phase I US trial of its third-gen BTK inhibitor (see story). The company describes IMG-004 as a highly selective and brain permeable non-covalent, reversible small molecule inhibitor for inflammatory/autoimmune diseases that require long-term treatment. IMG-004 is one of four novel pre-clinical immunological candidates that Inmagene in-licensed from HutchMed last year in a deal worth up to $920 million. BTK, a non-receptor intracytoplasmic tyrosine kinase, is involved in the innate and adaptive immune responses of specific immune-mediated diseases.
Germany’s Bayer AG (XE: BAYN) and Merck/MSD (NYSE: MRK) were approved to launch a novel cardiovascular drug in China (see story). Verquvo™ (vericiguat) is a soluble guanylate cyclase (sGC) stimulator that is indicated to reduce the risk of hospitalization or IV diuretics in patients with symptomatic chronic HF and reduced ejection fraction. Patients are prescribed the drug following a decompensation event. Verquvo’s novel mechanism restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure by aggravating its symptoms. Verquvo was approved as an addition to standard-of-care.
Shanghai Ascentage Pharma (HK: 6855) reported that olverembatinib effectively inhibited cytokine release storm in a preclinical test of the SARS-CoV-2 omicron variant (see story). The study was conducted by researchers from Fred Hutchinson Cancer Research Center in Seattle. Olverembatinib is already approved in China for two forms of chronic myeloid leukemia. Although most COVID-19 patients develop only mild to moderate symptoms, 15-20% of them face the hyper-inflammation induced by a cytokine storm, which leads to respiratory failure. Ascentage said it anticipates follow-up studies of olverembatinib in patients with severe cases of COVID-19.
Green Valley Pharmaceuticals has stopped the international Phase III trial for its Alzheimer’s disease treatment, citing difficulties caused by COVID and the current “funding winter” of raising capital (see story). Green Valley’s Alzheimer’s therapy was granted a surprise China approval in 2019, the first new AD treatment in 16 years. GV-971, a product derived from seaweed, has a unique mechanism that targeted gut biota to prevent the buildup of amyloid/tau related tangles in the brain. Following China approval, Green Valley started a global five-year Phase III trial in over 2,000 people to internationalize its novel therapy.
Zenas BioPharma filed a China IND for Phase I/II trials of a therapy for Thyroid Eye Disease (TED) (see story). Zenas is a Shanghai-Boston biopharma that specializes in immune-based therapies. ZB001 is a differentiated humanized mAb targeting insulin-like growth factor 1 receptor (IGF-1R) for TED, a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye. TED can cause double vision, pain and blindness. Zenas acquired greater China rights to ZB001 from Viridian along with other compounds targeting IGF-1R in non-oncology indications.