publication date: May 1, 2021
author/source: Richard Daverman, PhD
Deals and Financings
CANbridge Pharma of Beijing acquired a global license to LogicBio’s adeno-associated virus (AAV) sL65 in gene therapy candidates for Fabry and Pompe disease treatments (see story). CANbridge also will have an option on sL65 for two additional indications and an option on LogicBio's lead drug, LB-001, in China. CANbridge will make a $10 million upfront payment for the two Fabry and Pompe candidates. If the other two options are exercised and all milestones are achieved, CANbridge would make $581 million in payments. Based in Boston, LogicBio develops gene therapies for rare diseases in children.
CANbridge Pharma of Beijing has acquired Greater China rights to develop maralixibat, a treatment for a set of rare inherited childhood liver diseases caused by impaired bile flow (see story). Mirum Pharma (NSDQ: MIRM) is developing maralixibat, a clinical-stage oral medication, for Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia. CANbridge will pay $11 million upfront and be responsible for $109 million in milestones, plus royalties. It will also oversee Mirum’s clinical sites in China to accelerate enrollment of a global Phase IIb maralixibat test for biliary atresia.
VivaVision Biotech of Shanghai completed a $46 million Series D financing to develop novel drugs for chronic ocular or dermal inflammatory diseases (see story). VivaVision is developing four molecules including its lead candidate, VVN001, a treatment for dry eye that is being tested in a Phase II study in the US. The company is also developing products for glaucoma. VivaVision was originally incubated by Vivo Biotech, a structure-based drug discovery CRO. The D round was led by Sequoia Capital China.
Adcentrx Therapeutics. a Shanghai-San Diego startup, closed a $50 million Series A financing to develop next-gen ADC candidates for cancer and other serious diseases (see story). The company will accelerate breakthroughs in protein conjugate therapies, which combine the precision of biologics with powerful small molecule payloads. The financing was led by CBC Group (formerly C-Bridge Capital). Zoo Capital, Boyu Capital's venture arm, also joined the round.
Tianhong Shengjie, a Suzhou company developing medical devices for venous diseases, completed a $12 million Series B financing (see story). Founded in 2016, Tianhong Shengjie claims to be the first China novel medical device company developing interventional devices with independent IP. In five years, the company has registered four products for use in China. New investors in the round include Guolian Investment, Lotus Lake Ventures, Purple Bell Startups and Ningbo Kangtuo.
Sirnaomics Biopharma (Suzhou) out-licensed Greater China rights for its anti-influenza siRNA therapeutic candidate to Walvax Biotech, a Kunming vaccine company (see story). Walvax made a $6.4 million upfront payment and will also be responsible for undisclosed milestone and royalty payments. To develop STP702, Sirnaomics identified potent siRNA sequences that target highly conserved regions of influenza viral genes, a combination that exhibited broad anti-influenza activity. The nanoparticle-enhanced siRNA delivery also improves the candidate's anti-influenza activity, which is higher than marketed flu products, the company said.
dMed Global, a Shanghai clinical CRO, merged with Clinipace, a North Carolina clinical CRO, to offer cross-border clinical contract research services (see story). In 2016, dMed was founded by Dr. Lingshi Tan, who had been the first General Manager of Pfizer's China R&D Center. In 2019, dMed acquired US-based Target Health, a high-tech CRO with expertise in digital capabilities and regulatory affairs. dMed employs nearly 700 professional staff in more than 31 China cities and three US offices. Both CROs offer services to biotech, pharma and medical device companies.
Guangzhou Link Health Pharma and Australia's George Clinical plan to form a China clinical CRO JV that will conduct trials for Link Health's in-licensed portfolio (see story). George Clinical is a global clinical CRO headquartered in Sidney. Link Health will be the majority owner of Link-George Clinical Research, which will start six clinical trials in 2021. That will expand as Link Health acquires additional drug candidates, and it will also involve trials for Link Health's partner companies. George Clinical will be in charge of operating the JV. So far, the two companies have signed a term sheet.
Trials and Approvals
Nanjing Legend Biotech (NSDQ: LEGN) filed for EU approval of its BCMA CAR-T candidate in patients with multiple myeloma (see story). In 2017, Legend stunned participants at the US ASCO meeting with the 94% complete remission rate of the CAR-T candidate. Later that year, Janssen Pharma, a division of Johnson and Johnson, paid $350 million upfront to partner the drug. Legend-Janssen is seeking European approval of ciltacabtagene autoleucel (cilta-cel) in patients with relapsed or refractory multiple myeloma, based on 95% overall response and 56% complete response in a Phase Ib/II study.
Suzhou's CStone Pharma (HK: 2616) reported China's NMPA accepted for review its NDA for Gavreto® (pralsetinib) to treat advanced or metastatic RET-altered thyroid cancer (see story). In March, the NMPA approved pralsetinib to treat RET fusion-positive non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. Discovered by CStone's partner Blueprint Medicines, Gavreto® is approved in the US and is the first approved selective RET inhibitor in China. In 2018, CStone acquired China rights to three cancer candidates from Boston's Blueprint in a $386 million deal.
Shanghai Fosun Pharma (SHA: 600196; HK: 02196) has started a China Phase III trial of its next-gen long-lasting Botox drug (see story). It will test the drug as a therapy for glabellar (frown) lines and cervical dystonia (involuntary contraction of the neck muscles). In 2018, Fosun acquired rights to DaxibotulinumtoxinA from Revance Therapeutics of Nashville, TN in a $260 million deal. So far, Fosun has made a $30 million upfront payment. Revance has already concluded a successful US Phase III trial of the candidate as a treatment for glabellar lines.
Shanghai's I-Mab (NSDQ: IMAB) reported positive topline data from a Phase II trial of a selective IL-6 inhibitor in patients with ulcerative colitis (see story). I-Mab says olamkicept is the only clinical stage IL-6 inhibitor that works via a trans-signaling mechanism. Other IL-6 therapies cause total inhibition of IL-6 signaling, including inhibiting homeostatic effects, which is associated with significant adverse events. In the double-blind Phase II trial, olamkicept met its primary and secondary endpoints. I-Mab acquired greater China rights to the IL-6 antagonist in 2016 from Swizterland's Ferring Pharma.