publication date: Apr 24, 2021
author/source: Richard Daverman, PhD
Deals and Financings
Zai Lab (NSDQ: ZLAB; HK: 9688) raised a staggering $750 million in a public offering of its dual US/Hong Kong-listed stock (see story). Led by Samantha Du, PhD, an early China drug developer, Zai began as a China-based in-licensing company that has since expanded into novel drug development. It currently has a portfolio of 21 products. Zai has a market cap of $14 billion and over $1 billion in cash, not including this latest raise. The company said it will direct 30% of the proceeds to additional business development and licensings.
Beijing's EdiGene completed a $62 million Series B Plus financing to support its gene editing drug development efforts. Earlier this year (see story), Edison was approved to start a clinical trial of its lead product, an investigational CRISPR/Cas 9 gene-editing therapy for patients with transfusion dependent β-thalassemia. It is the first gene-editing therapy and the first hematopoietic stem cell therapy IND approved in China, EdiGene said. The company uses its genome editing technologies to accelerate drug discovery and develop novel candidates for genetic diseases and cancer.
Suzhou Porton Biologics, a gene and cell therapy CDMO service company, closed a $61 million Series A funding (see story). In late 2020, the Phase I part of Porton's GMP facility was approved, and it began offering services that range from process development to clinical production of plasmids, viral vectors and cell therapies. Proceeds from the financing will support Phase II construction. Porton Biologics is a subsidiary of Chongqing-headquartered CDMO Porton Pharma Solutions (SHA: 300363).
Shanghai Junshi Bio (HK: 1877; SHA: 688180) completed its $50 million investment into its US partner, Coherus Biosciences (NSDQ:CHRS) (see story). In February, the two companies announced a $1.1 billion agreement, including a $150 million upfront payment to Junshi, that gives Coherus the right to commercialize Junshi's anti-PD-1 antibody in the US and Canada. One day later, Junshi announced it would make a $50 million investment in Coherus. Junshi's Tuoyi (toripalimab) was the first China-developed anti-PD-1 antibody approved in China.
Ronovo Surgical, a Shanghai company developing novel minimally invasive and digital surgery devices, announced it has completed a Series A financing (see story). Ronovo was founded in 2019 by surgeons, medtech veterans and robotics experts to bring the latest surgical technologies to China's market. The company has established a soft tissue surgical robotics R&D program and will also license technology from other surgical device companies. The Series A round was co-led by Matrix Partners China and Vivo Capital, with support from seed investor Lilly Asia Ventures and participation from GGV Capital.
Tianjin CanSino Biologics (HK: 6185; SHA: 688185) will start a clinical trial of an inhaled COVID-19 vaccine in China (see story). CanSino worked with the Beijing Institute of Biotechnology to develop the product. Besides the easier delivery method, Xuefeng Yu, chairman and CEO of CanSino suggested it might be effective in infected individuals. Because the virus often enters a body via the airway, anyone already infected would already have a layer of antibody, or T memory cells, which could be quickly activated, he said.
RNAImmune, a spinout from Sirnaomics, raised $10 million in seed capital to develop mRNA therapeutics and vaccines (see story). Sirnaomics, a Maryland-Guangzhou biopharma, discovers and develops RNAi therapeutics for cancer and fibrotic disease indications. Founded in 2020, RNAimmune is in the IND enabling stage for its lead candidate, a COVID-19 mRNA vaccine with plans to file an IND with the US FDA before the end of 2021. The seed round was led by Smooth River of Las Vegas and Hong Kong Hongrun. http://www.chinabiotoday.com/articles/rnaimmune-10-million
Trials and Approvals
Shanghai Henlius Biotech (HK:2696) said the NDA for its novel anti-PD-L1 candidate has been accepted for review by China's NMPA (see story). Serplulimab injection (HLX10) was tested in patients with unresectable or metastatic microsatellite instability-high (MSI-H) solid tumors who did not respond to the standard therapy. It has the potential to be the first anti-PD-1 mAb approved for MSI-H solid tumors in China, the company said. So far, Henlius, an affiliate of Fosun Pharma (SHA: 600196; HK: 02196), has launched three biosimilars in China.
Shanghai Junshi Biosciences (HK: 1877; SHA: 688180) stopped the Phase III trial of its anti-PD-1 candidate early because toripalimab met its survival endpoints at an interim review (see story). Toripalimab was administered together with paclitaxel/cisplatin as a first-line treatment for patients with advanced esophageal squamous cell carcinoma. The combination met the pre-specified primary endpoints of Progression Free Survival and Overall Survival in a double-blind Phase III trial. Toripalimab is already approved for three other indications in China.
Transcenta Holding, a Suzhou biopharma, was approved to start a US Phase I trial of its bi-functional anti-PD-L1/TGF-β antibody in patients with solid tumors (see story). Transcenta plans to add a China arm to the trial when China approves its already-filed IND for the bi-specific candidate. Previously, the company started Phase II trials of its anti-PD-L1 candidate as a stand-alone product in China and the US. TST005 consists of a high affinity PD-L1 antibody fused with an engineered TGF-β Receptor (transforming growth factor -β) Type II protein in its C-terminal.
Shanghai's PhageLux, an antimicrobial company, announced its agricultural division, PhageLux AgriHealth, has acquired a new manufacturing facility in Yixing, Wuxi (see story). The company plans to spend the rest of 2021 renovating the plant. When finished, it will include a 1000 square meter research lab with pilot scale GMP manufacturing for new veterinary drugs. and 2000 square meters to produce feed additives (powder) and animal health products (liquid). The company's human health division uses bacteriophages, lyases and new drug delivery systems to create novel therapies for patients with skin diseases.