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Deals and Financings

• Yantai's RemeGen (9995.HK) out-licensed global rights (ex-Asia) for its novel HER2-targeted ADC to Seagen (SGEN) in a $2.6 billion deal (see story). Seagen, an antibody conjugate company previously known as Seattle Genetics, will pay $200 million upfront and up to $2.4 billion in milestones. The candidate, disitamab vedotin, combines Seagen's drug-linker technology with RemeGen’s novel HER2 antibody. The candidate has shown promising activity in trials involving several solid tumor types associated with HER-2, including urothelial, gastric, and breast cancers. The deal is the latest billion-dollar-plus cross-border agreement involving a China life science company.  
• XtalPi, a US-China AI-based drug discovery company, completed a $400 million Series D financing at an estimated valuation of $2 billion (see story). XtalPi says its Intelligent Digital Drug Discovery and Development (ID4) platform combines quantum physics, AI, and cloud computing algorithms to provide predictions on the properties of small-molecule candidates. The financing was led by OrbiMed Advisors and RRJ Capital. The company emphasizes its expertise in solid state drug R&D with a specialty in crystal structures. One year ago, XtalPi completed a $318 million Series C round.  
• Shanghai's HutchMed (HCM) announced a $310 million deal to acquire greater China rights to Epizyme's (EPZM) epigenetic treatment for niche cancers (see story). Tazverik® is a methyltransferase inhibitor of EZH2 developed by Boston's Epizyme that is approved is the US to treat patients with epithelioid sarcoma or follicular lymphoma. HutchMed has not previously in-licensed any products. It will pay $25 million upfront and the rest in milestones. In addition, HutchMed will have a four-year warrant to acquire up to $65 million of Epizyme shares.  
• Sorrento Therapeutics (SRNE), a San Diego-Suzhou biopharma, signed a binding term sheet to license and develop vaccines, therapeutics, and diagnostics using a proprietary C1-cell protein production platform developed by Florida's Dyadic International (DYAI) (see story). The agreement includes rights to Dyadic's lead COVID-19 vaccine, which is already in preclinical testing being conducted by Sorrento. Sorrento will pay $10 million upfront, with up to $33 million in milestones plus royalty payments. Dyadic says exclusive access to its platform is dependent on Sorrento achieving specific milestones on time. 

COVID-19 Pandemic

• Advaccine Biopharma Suzhou and Sinovac Biotech will conduct two China trials of Sinovac's approved COVID-19 vaccine combined with US-based Innovio's (INO) DNA vaccine candidate for COVID-19 (see story). Earlier this year, Advaccine announced a $108 million agreement to acquire China rights to the Innovio vaccine. In animal testing, the combination of INO-4800 and Sinovac's CoronaVac, an attenuated vaccine, produced a higher response against the virus. Advaccine is sponsoring the trial.  

Trials and Approvals

• Suzhou Innovent Bio (1801.HK) reported its PCSK-9 inhibitor mAb met its primary endpoint in a Phase III trial in China patients with heterozygous familial hypercholesterolemia (see story). After 12 weeks of treatment, IBI306 patients showed significantly lower levels of low-density lipoprotein cholesterol than placebo. Safety profiles were similar to other marketed PCSK-9 inhibitors. Innovent pointed out that the results were the first Phase III trial of a PCSK-9 candidate in China patients.  
• PhaseBio Pharma (PHAS) and SFJ Pharma announced their partnered drug, bentracimab, was approved to start a China Phase III trial (see story). PB2452 is a reversal agent for an antiplatelet therapy, ticagrelor, in major bleeding and urgent surgery situations. In January 2020, the Bay Area's SFJ entered a $120 million deal to support clinical trials of the drug, which was developed by Pennsylvania's PhaseBio. SFJ assumed a role in the clinical trials of the drug outside of the US and will be paid up to five times the $120 million in milestones over eight years.  
• Hangzhou Lynk Pharma has started a US Phase I trial of its novel triple-kinase inhibitor in patients with myelofibrosis (see story). The trial will enroll patients with primary myelofibrosis (PMF) and secondary myelofibrosis (PV/ET-MF) induced by polycythemia vera or primary thrombocytosis. LNK01002 targets three kinase drivers of PMF and PV/ET-MF with the potential to treat patients who are not responsive or have developed resistance to conventional therapies. Founded in 2018, Lynk discovers and develops innovative drugs to treat cancer, as well as immune and inflammatory diseases.  
• Shanghai Belief Biomed was approved to start China trials of its IV infusion gene therapy for Hemophilia B (see story). It is the first approval of an IV gene therapy for the indication and for a rare disease in China. BBM-H901 is a bio-engineered adeno-associated viral vector using a novel recombinant AAV capsid. The capsid contains a codon-optimized human factor IX gene under the control of a liver-specific promoter. It has shown high efficacy and safety, offering a one-time treatment for Hemophilia B that would liberate patients from regular treatment.  
• Junshi Biosciences (1877.HK) of Shanghai and its US partner Coherus Bio (CHRS) reported their PD-1 candidate was granted a second Breakthrough Therapy Status in the US (see story). Toripalimab, the anti-PD-1 discovered by Junshi, was awarded BTK as a first-line therapy in nasopharyngeal carcinoma in combination with chemotherapy. Previously, it received BTD for second-line NPC as a single agent. Earlier this year, Junshi out-licensed US/Canada rights for toripalimab to Coherus in a $1.1 billion deal.