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Deals and Financings

• Shanghai Nuance Pharma in-licensed China and Southeast Asia rights to a respiratory syncytial virus (RSV) vaccine from Copenhagen’s Bavarian Nordic (BVNRY) in a $225 million deal (see story). The vaccine is aimed at older and/or immunocompromised adults. Nuance will conduct Phase I and III trials of MVA-BN® RSV in China. Bavarian Nordic will receive an upfront payment of $12.5 million and is eligible to receive milestones of up to $212.5 million, plus tiered, double-digit royalties on net sales. Bavarian Nordic is planning to start its own US Phase III trial in the first half of 2022. 
• Jiangsu Recbio Technology is conducting a $98 million Hong Kong IPO to support development of its vaccine portfolio (see story). Recbio has a portfolio of 12 vaccine candidates including its lead product, a recombinant HPV 9-valent vaccine that is currently being tested in a Phase III clinical trial. The company is focused on protein-based subunit vaccines that present an antigen to the immune system without viral particles. Last year, Recbio formed a JV with Shenzhen Rhegen Biotech to develop an mRNA vaccine for COVID-19. 
• Beijing YishengBio completed a $40 million Series C round in a royalty-based transaction with R-Bridge, a division of CBC Group focused on royalty transactions (see story). Founded in 1994, Yisheng develops products based on its PIKA immunomodulatory adjuvant for vaccines, cancer, and infectious diseases. The PIKA technology increases innate and adaptive immune responses via the TLR3, RIG-I and MDA5 pathways. The company has also developed a COVID-19 vaccine with potential for therapeutic use that is undergoing clinical trials. One year ago, YishengBio closed a $130 million B round led by OceanPine and OrbiMed. 
• OBiO Technology (688238.SS), a Shanghai CDMO for gene and cell therapies, completed an IPO on the Shanghai STAR Exchange and traded 67% higher on its first trading day, an unusually strong performance in the current market (see story). The company did not disclose how much the offering raised. Founded in 2013, OBiO is a contract research organization for vectorology and functional genomics studies. It also provides contract development and manufacturing services of IND-enabling CMC, along with clinical and commercial manufacturing. To date, the company has supported more than 100 gene and cell therapy programs. 
• Sino Biological (301047.SZ) partnered with California’s Ainnocence to add the company’s AI-based prediction technology to its antibody development CRO services (see story). Ainnocence said its platform provides fast, efficient and accurate prediction of antibody-antigen interaction, including binding affinity assessment. The third-generation AI system delivers virtual screening and multi-objective pharmacological profile optimization for small molecule, antibody, and other complex therapies. Sino Bio is a global reagent supplier that also offers CRO services. Terms of the agreement were not disclosed. 

COVID-19 Pandemic

Shanghai Fosun Pharma (600196.SS) reported it sold over 20 million doses (worth $157 million) of its COVID-19 mRNA vaccine during 2021 in Hong Kong, Macau, and Taiwan (see story).

Comirnaty®, an mRNA COVID-19 vaccine, was developed by Fosun and Germany’s BioNTech. It is not approved for Mainland China use. Fosun, which completed China trials of the vaccine some time ago, said it is talking with China health regulators and expects approval by July at the latest.

Trials and Approvals

• Shanghai Henlius Biotech (2696.HK) announced its proprietary PD-1 inhibitor Hansizhuang (serplulimab injection) was approved in China to treat MSI-H (Microsatellite Instability-High) solid tumors that did not respond to standard treatments (see story). The approval was based on on a single-arm, pivotal Phase II clinical study that showed an objective response rate of 40%. Using Hansizhuang as a backbone, Henlius conducts clinical trials with immuno-oncology combination therapies worldwide in several high-incidence solid tumors, including lung cancer, esophageal carcinoma, head and neck carcinoma, and gastric cancer. 
• Eli Lilly (LLY) reported that the US FDA formally rejected its anti-PD-1 antibody sintilimab, which it produces with China’s Innovent Pharma (see story). The rejection was expected after the advisory committee voted almost unanimously against approval last month. Lilly-Innovent was seeking approval of the PD-1 as a first-line therapy for nonsquamous non-small cell lung cancer. Lilly did not immediately say it would conduct a new Phase III trial in the US. Instead, the company said it was assessing the US situation together with Innovent. 
• Jiangsu Atom Bioscience said its treatment for gout met its primary efficacy endpoint in a double-blind placebo-controlled Phase IIa trial (see story). ABP-671 is a small molecule inhibitor of the urate transporter protein that increases the excretion of uric acid to prevent gout attacks. Atom says ABP-671 reduced serum uric acid levels  to less than 6 mg/dL, below the clinically defined threshold of 7 mg/dL, without showing any serious safety concerns. Earlier this year, Atom Bio closed a $45 million Series C financing to support a global Phase III clinical trial of ABP-671. 
• Suzhou Ascentage Pharma (6855.HK) announced its novel MDM2-p53 inhibitor was granted US Rare Pediatric Disease to treat neuroblastoma (see story). Alrizomadlin is an oral small-molecule inhibitor of the MDM2 protein that is designed to activate p53 tumor suppression by blocking MDM2-p53 protein-protein interaction. Neuroblastoma, the most common extracranial solid tumor in children and the third most common pediatric cancer, often has a poor prognosis. So far, alrizomadlin has received six Orphan Drug Designations and two RPDs from the FDA. Ascentage is testing alrizomadlin in a Phase II trial to treat immunotherapy-resistant advanced solid tumor cancers.