Nov 13, 2021

publication date: Nov 13, 2021  |  Deals and Financings Shanghai Zai Lab (NSDQ: ZLAB; HKEX: 9688) announced two major in-licensings: a $615 million deal for two cancer drugs from Blueprint Medicines and a $187 million agreement for a psychiatric drug from Karuna Therapeutics (NSDQ: KRTX) (see story ). Zai will have greater  China  rights to two Blueprint next-gen EGFR candidates aimed at non-small cell lung cancer (NSCLC), which Blueprint says have first-in-class potential. Karuna's KarXT is a M1/M4-preferring muscarinic agonist that has shown preliminary benefits for patients with psychosis from schizophrenia and Alzheimer's. KarXT is Zai's first neurologic drug candidate. I-Mab (NSDQ: IMAB) of Shanghai formed a $315 million collaboration with Hubei Jumpcan Pharma (SHA: 600566) to commercialize its human growth hormone in  China (see story ). Jumpcan, which will pay $35 million upfront, specializes in pediatric drugs. Earlier this year, I-Mab started a pivotal China Phase III trial of eftansomatropin alfa as a weekly treatment for pediatric growth hormone deficiency (PGHD). The two companies will split commercialization revenues 50/50, with I-Mab also receiving royalties on sales. Most  China Arbor Biotech, a  China  rights to six of SK's CNS drugs in exchange for $20 million upfront and a $15 million milestone payment. Ignis will also pay royalties on sales. SK plans to acquire 150 million Ignis shares before the end of the year. Hopstem Biotech, a China-US stem-cell therapy company, completed a near $40 million B financing, led by an unnamed VC/PE with participation by Lilly Asia Ventures and YuanBio Venture Capital (see story ). The company's lead product is an off-the-shelf induced pluripotent stem cells (iPSC)-derived human forebrain neural progenitor cell product. Hopstem has built a neural differentiation platform and established a patented method to reprogram iPSC cells. Founded in  2017 by neuroscientists and stem-cell biologists from Johns Hopkins, Hopstem has operations in  Hangzhou Hangzhou 's Ascletis Pharma (HK; 1672) extended its partnership with Suzhou Alphamab to include global rights for its PD-L1 as a viral disease therapy (see story ). Previously, Ascletis held only Greater China rights to the candidate. Ascletis is especially interested in developing the PD-L1 to treat Hepatitis B. Alphamab says ASC22 is a first-in-class subcutaneously injected PD-L1 antibody that it is developing for oncology indications. Ascletis will make upfront and milestone payments to Alphamab, plus royalties of up to 20%, but further specific details were not disclosed. Trials and Approvals  Everest Medicines (HK 1952) reported its novel TROP-2 antibody-drug conjugate met its primary endpoint in a China Phase II trial in metastatic triple-negative breast cancer (TNBC) patients (see story ). In 2019, Everest in-licensed the candidate in an $835 million agreement. Sacituzumab govitecan, which is marketed as Trodelvy® in the  US Gilead (NSDQ: GILD), met its primary endpoint of overall response rate as a third line treatment for TNBC. Earlier this year, Everest began a China Phase III trial of the ADC in patients with metastatic urothelial cancer. Ascletis Pharma (HK: 1672) of  Hangzhou  was approved to start a China Phase II clinical trial of its PD-L1 candidate in HIV-1 patients (see story ). ASC22 will be tested as an immune restoration/functional cure of HIV-1. Earlier this week, Ascletis announced it had added global rights to its agreement with Suzhou Alphamab for the PD-L1 in China viral disease indications. Previously, Ascletis was testing ASC22 (envafolimab) to treat/cure chronic hepatitis B. ASC22 is a single domain PD-L1 antibody with the potential to restore immune responses in patients with chronic viral infections. Gmax Biopharm, a novel Hangzhou antibody company focused on GPCRs, has begun a China Phase I trial of its obesity therapy (see story ). GMA106 is Gmax's second-gen mAb therapy aimed at obesity/T2DM/NASH. It combines Gmax's GPCR mAb with its M-Body technology, which aims at two different targets for better efficacy. In this case the M-Body pairs an anti-GIPR antibody fused with a GLP-1 peptide. Patients in the Phase I trial will be given a single dose of GMA106. The trial will be structured as a placebo controlled, double blind, randomized, dose escalating study. Nanjing IASO Bio dosed the first patient in a China Phase I/II trial of its fully human CD19/CD22 CAR-T cell therapy (see story ). The trial will enroll patients with CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma. IASO said the candidate is the first fully human dual-targeted CAR-T cell therapy approved to start clinical trials. IASO plans to start a second trial of the CD19/CD22 CAR-T cell therapy in patients with relapsed/refractory B-cell acute lymphoblastic leukemia. Disclosure: none.