Hasten’s $325M Deal For China Rights To PCSK9 Cholesterol Therapy

Deals and Financings

Shanghai Hasten Biopharma entered a $325 million agreement for greater China rights to a PCSK9 inhibitor aimed at lowering cholesterol from US-based LIB Therapeutics. Lerodalcibep is a next-gen PCSK9 inhibitor that may overcome the limitations of current low-density lipoprotein products for patients at high-risk for cardiovascular disease. In a global Phase III trial, conducted in patients with difficult-to-treat disease, lerodalcibep reduced mean LDL-C in the intent-to-treat population by 58.6% at Week 24. Hasten will make an upfront payment of $20 million to LIB and be responsible for milestones of up to $305 million.

Insilico Medicine, a Hong Kong-New York AI drug discovery company, out-licensed global rights to a small molecule inhibitor of USP1 for BRCA-mutated tumors to Exelixis (EXEL) of Alameda, California (see story). Exelixis will pay $80 million upfront plus unspecified milestones and royalties. USP1 repairs DNA damage by removing ubiquitin from multiple substrates. Exelixis will also have rights to other Insilico-discovered USP1 candidates. Founded in 2018, Insilico has partnered with US and China biopharmas to discover candidates for specific targets, including a six-drug deal worth up to $1.2 billion with Sanofi (SNY).

Suzhou Cure Genetics, a cell and gene therapy company, announced a $60 million deal to create AAV vectors for Hong Kong’s Frametact, a neurodegenerative disease startup. Frametact was founded by a molecular neuroscience research team at The Hong Kong University of Science and Technology and Hong Kong Center For Neurodegenerative Diseases. It targets familial diseases that include Alzheimer’s, Parkinson’s and Huntington’s disease. Cure, which will apply its VELP™ platform to develop novel Adeno-Associated Virus (AAV) vectors, will receive $60 million in upfront and milestone payments, plus royalties on revenues.

Last week, Shanghai ImmuneOnco Biotech (HK: 01541) completed a $30 million IPO on the Hong Kong Stock Exchange to support its portfolio of oncology candidates that exploit innate and adaptive immunity. The company contrasts its portfolio with most other companies that stress adaptive immunity only, which it says causes low response rates and inevitable drug resistance. ImmuneOnco’s lead product, IMM01, is a next-gen CD47-targeted molecule currently in China Phase II clinical trials. IMM01 is a recombinant human SIRPα IgG1 fusion protein that simultaneously blocks a “don’t eat me” signal mediated by CD47/SIRPα and activates an “eat me” signal by interacting with FcγRs on macrophages.

Shanghai JW Therapeutics (OTCPK:JWCTF) will add two additional candidates for China to its T cell-based therapeutics collaboration with Boston’s 2seventy bio (TSVT): a T-cell receptor molecule for solid tumors and a CAR T candidate for autoimmune diseases (see story). The collaboration, announced last year, was set up to advance 2seventy products into clinical trials quickly. One of the two original products, a MAGE-A4 solid tumor program, is expected to start an investigator study later this year, which is faster than expected. JW was formed by Wuxi Apptec (wixif) and Seattle’s Juno Therapeutics to bring cell therapies to China.

Shanghai Pharmaceuticals (OTCPK:SHPMF) signed an MOU with Korea’s AriBio to jointly conduct the China arm of a global Phase III trial of a therapy for mild Alzheimer’s disease (see story). AriBio’s AR1001 is a selective inhibitor of phosphodiesterase 5 (PDE5) that is designed to inhibit neuron apoptosis and restore synaptic plasticity. If the drug is approved, Shanghai Pharma will have distribution and manufacturing rights for the candidate in China. In a Phase II trial, AR1001 was safe, and it showed efficacy, especially if patients were not taking other Alzheimer’s medications, such as Aricept.

Trials and Approvals

Zhejiang BioRay Pharma was approved for a China launch of its Class I innovative therapeutic biological product, zuberitamab injection (Anruixi®), to treat CD20-positive diffuse large B-cell lymphoma. Anruixi is China’s first CD20 Class I mAb. It targets CD20 on the surface of B-cell, leading to B-cell elimination via ADCC and CDC. The company believes its product has a stronger ADCC effect than the competition. Anruixi is the first China-developed Class I anti-CD20 drug approved for China use and BioRay’s sixth marketed product. BioRay is conducting trials of Anruixi for autoimmune diseases, including primary immune thrombocytopenia.

Shanghai Dizal Pharma (SHA: 688192) reported its NDA for golidocitinib was accepted by China’s CDE for review as a treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor that showed efficacy in a global, multicenter pivotal study. In a trial that enrolled 112 r/r PTCL patients, golidocitinib produced an ORR of 44% and a CRR of 24%. One month ago, Dizal announced that its lead drug, sunvozertinib, was approved for China use as a second line therapy for NSCLC with EGFR exon 20 insertion mutations.

San Diego’s Sorrento Therapeutics (OTCPK:SRNEQ) reported positive topline results of a pivotal China Phase III trial of an oral Mpro inhibitor, Ovydso (olgotrelvir), a treatment for mild or moderate SARS-CoV-2 (see story). The candidate works by inhibiting the virus from entering cells. Ovydso met the trial’s endpoints by lowering the time to sustained recovery of 11 COVID-19 symptoms: 8.6 days compared to 11.0 days in the placebo group. It also reduces the viral RNA copy load at Day 4 (after the three-day treatment). The trial enrolled 1,212 patients at 25 China sites.

Biosyngen, a Singapore-Guangzhou cell therapy company, was green-lighted to begin a US Phase I/II clinical trial of its first T-cell receptor-engineered targeted (TCR-T) product for lung cancer, gastric cancer and other advanced solid tumors. The approval for BRL03 is the company’s third first-in-class therapy and its first self-developed candidate to start clinical trials. Biosyngen is currently filing an IND application for BST02, a tumor-infiltrating lymphocyte (TIL) molecule. When BRL03 is approved, the company will have clinical-stage assets in all three major T-cell therapy types — CAR-T, TCR-T and TIL. h

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