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COVID-19 Pandemic

• Suzhou Abogen Biosciences raised over $700 million in a record-breaking Series C round to support a Phase III trial of its mRNA COVID-19 vaccine (see story). The company has completed a Phase II trial of the vaccine but hasn't released any data from the trial. The Phase III trial started in May of this year. Abogen is developing ARCoV together with a China military medical research group and Walvax Biotech (300142.SZ). The funding was led by seven investors, including Temasek Holdings, Singapore's state-owned investment fund, and Hillhouse-backed GL ventures.  
• Brii Bioscience (2137.HK), a Beijing-North Carolina company, reported that its combination monoclonal antibody therapy reduced hospitalization and death in early-stage COVID-19 patients (see story). In an interim analysis of the US Phase II/III trial, the BRII-196/BRII-198 combination lowered hospitalization/death by 73% compared to placebo. Brii will continue analysis of subgroups to identify the clinical benefits of early (≤5 days) versus late (6-10 days) treatment, which will be useful for making clinical treatment decisions. Brii has also started a China trial of the combination therapy.  

Deals and Financing 

• BeyondSpring (BYSI), a New York City-China company, signed a $200 million agreement with Jiangsu Hengrui Pharma (600276.SS) to partner China commercialization of its lead oncology drug (see story). In exchange for Greater China marketing rights to plinabulin, BeyondSpring’s 58%-owned China subsidiary, Wanchunbulin, will receive $30 million upfront and up to $170 million in milestones. Earlier this month, BeyondSpring reported positive topline data from a US Phase III trial of plinabulin among NSCLC patients.  
• Beijing Kangle Weishi Biotech completed a $157 million pre-IPO financing round to develop recombinant vaccines that are based on its virus-like particle (VLP) platform (see story). Specifically, the company will start Phase III trials of its trivalent papillomavirus HPV 16/18/58 recombinant vaccine and 9-valent recombinant HPV 6/11/16/18/31/33/45/52/58 vaccine. In addition, it will build a vaccine industrial complex in Kunming, plus develop recombinant norovirus and recombinant coronavirus vaccines. The investors include CCB International, YF Capital, Jemincare, Yingke PE, and others.  
• Suzhou Alphamab Oncology (9966.HK) out-licensed China rights for its anti-HER2 bispecific antibody to CSPC Pharma (1093.HK) in a deal worth up to $150 million, plus royalties (see story). JMT-Bio, a CSPC subsidiary, will own KN026 rights for breast cancer and gastric or gastroesophageal junction cancers. It will be responsible for the cost of all clinical trials in China. Alphamab developed KN026 to bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade.
• Guangzhou Bio-Thera Solutions (688177.SS) out-licensed US commercialization rights for its Stelara® (ustekinumab) biosimilar to Hikma Pharma (LSE: HIK) in a $150 million agreement (see story). Jansen’s Stelara® inhibits inflammation in autoimmune disorders including Crohn's disease and ulcerative colitis. One month ago, Bio-Thera started US-EU Phase III clinical trial of BAT2206 in psoriatic (PsO) patients,  Bio-Thera will receive $20 million upfront and up to $130 million in milestones. Hikma also has a first-right-to-negotiate for European rights to the biosimilar.  
• Lynk Pharmaceuticals completed a Series B financing of $50 million to conduct Phase I/II clinical trials of its pipeline products and expand its international business (see story). Founded in 2018 by veteran drug hunters with experience working for Pfizer (PFE), Merck (MRK), and Johnson & Johnson (JNJ), Lynk is developing FIC/BIC small molecule drugs for autoimmune diseases, inflammation and cancer. The financing was led by Lilly Asia Ventures, plus New Alliance Capital, and Hangzhou HEDA Biological Medicine as co-investors.
• Ocumension Therapeutics (1477.HK) of Shanghai acquired China rights (including manufacturing) for two approved ophthalmic drugs from Novartis (NVS) in a $35 million deal (see story). The drugs, Emadine® and Betopic® S, target conjunctivitis and intraocular internal pressure respectively. Ocumension's ophthalmic drug portfolio now includes 20 products, with four already commercialized and five in Phase III clinical trials worldwide. In 2020, Ocumension completed a $184 million IPO in Hong Kong, and it began building a manufacturing facility in Suzhou earlier this year.  
• Suzhou Innovent Bio (1801.HK) and San Francisco's Bolt Bio (BOLT) will partner to discover three immune-stimulating antibody conjugate (ISAC) candidates for cancer (see story). The conjugate molecules will combine antibody targeting with the power of the innate and adaptive immune systems. Innovent will apply its discovery capability on undisclosed oncology targets. while Bolt will add its ISAC technology and myeloid biology expertise to initiate a new class of immuno-oncology agents. Bolt will receive an upfront payment of $5 million and is eligible for a $10 million equity investment.  

Trials and Approvals 

• Shanghai Everest Medicines (1952.HK) has begun a China Phase III trial of sacituzumab govitecan-hziy in patients with metastatic urothelial cancer (see story). The Everest trial is the China arm of a global test of the drug being conducted by Gilead (GILD). The candidate is a first-in-class, antibody-drug conjugate aimed at TROP-2, which is over-expressed in many epithelial cancers. In 2019, Everest entered an $835 million agreement ($65 million upfront) to acquire China rights to the ADC. Everest completed a $451 million IPO in Hong Kong last year.  
• Shanghai Reistone Biopharma reported positive results from a Phase II trial of its JAK1 inhibitor for alopecia areata, an autoimmune disease (see story). Two doses of once-daily SHR0302 showed a statistically significant percentage change of SALT score, a quantitative indicator of AA severity based on scalp hair loss. Reistone in-licensed the JAK1 inhibitor from Jiangsu Hengrui, which also backs Reistone. Formed in January 2018, Reistone focuses on globalizing innovative drugs developed in China. The Phase II trial was conducted in Australia, China, and the US.  
• LianBio, a Shanghai-Princeton in-licensing company, has started a China Phase IIa trial of infigratinib, an FGFR2 inhibitor (see story). The trial will enroll patients who have gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification. One year ago, LianBio acquired China rights to the candidate from BridgeBio (BBIO) as part of a two-drug, $531 million agreement. Infigratinib, which is approved in the US to treat cholangiocarcinoma with a FGFR2 fusion, is the first LianBio asset to start clinical trials.