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Deals and Financings

• Shanghai Zai Lab (ZLAB) announced two major in-licensings: a $615 million deal for two cancer drugs from Blueprint Medicines (BPMC) and a $187 million agreement for a psychiatric drug from Karuna Therapeutics (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 (IMAB) of Shanghai formed a $315 million collaboration with Hubei Jumpcan Pharma (600566.SS) 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 recombinant human growth hormone therapies require daily injections, which lowers patient compliance.  
• Arbor Biotech, a Cambridge MA gene editing company, raised $215 million in an oversubscribed B round led by Temasek (the sovereign wealth fund of Singapore) (see story), Ally Bridge (headquartered in Hong Kong), and TCG Crossover of the US. Arbor was founded in 2016 by star CRISPR-Cas9 researcher Feng Zhang, among others. Dr. Zhang has positions at MIT and the Broad Institute. Arbor has worked to develop additional gene editing technologies to CRISPER-Cas9, but now is pivoting towards developing therapies, with an initial aim at liver and CNS targets.  
• Ignis Therapeutics of Shanghai announced an initial funding of $180 million in a Series A round led by China's 6 Dimensions Capital (see story). The company, which was spun out from South Korea's SK Biopharma (326030.KS), plans to bring SK Biopharma's CNS drug assets to China. Initially, Ignis in-licensed 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 and Baltimore. 
• Hangzhou's Ascletis Pharma (1672.HK) 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 (1952.HK) 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 by Gilead (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 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 (9966.HK) 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.