Deals and Financings

Xbiome, a Shenzhen AI-based microbiome drug development company, in-licensed China rights to an inflammatory disease therapy developed by Aurealis, a Swiss synthetic biology company, in a deal worth up to $139 million (see story). Xbiome will develop AUP-16 in Greater China for Diabetic Foot Ulcer (DFU) and other chronic wounds. AUP-16 is a genetically engineered Lactococcus lactis, a non-pathogenic, probiotic bacteria. Last month, Xbiome completed a B+ funding of nearly $100 million. It has been approved to begin US trials of its lead program, an oral microbiome therapy for graft-versus-host disease.  

Cure Genetics of Suzhou closed a $60 million Series B round to advance clinical development of its cell therapy candidates for hematological and solid tumors (see story). Cure was established by CRISPR pioneers in 2016 to develop therapies for difficult-to-treat cancers and genetic diseases. Its CRISPR-mediated single or multiplex gene editing platform is aimed at producing more effective or safer cell therapy products, including universal CAR-T candidates. The financing round was led by Advantech Capital and joined by Oriza Holdings, Blue Ocean Private Equity and Qiming Venture Capital.  

Hong Kong's Grand Pharmaceutical (HK: 00512) acquired greater China rights to the Saturn Transcatheter Mitral Valve Replacement (TMVR) system developed by Milan's InnovHeart (see story). Grand Pharma will make an equity investment in InnovHeart, plus pay upfront licensing fees, milestone payments and structured royalties. InnovHeart said the transaction, including other investors' participation in the Series C financing, would total up to $55 million. Grand Pharma led the Series C equity round. It was joined by existing investors Genextra, Panakes Partners and Indaco Venture Partners.  

Xiamen Biotime Biotech in-licensed a package of five drug assets (mostly preclinical) from Adlai Nortye, a Hangzhou oncology company, in an agreement worth at least $32 million (see story). Adlai Nortye has built a pipeline of 10 candidates. Biotime, known for its point-of-care diagnostic devices, has recently branched out into drug development. It will have China rights including manufacturing for two of the candidates and global rights to the remaining three molecules. The China-only candidates are an oral small-molecule PD-L1 inhibitor and a novel humanized IgG1 (variant) anti-hTNFR2 antibody.  

Ractigen Therapeutics, an RNAa company, closed a Series A+ financing totaling $30 million to bring its portfolio of 10 programs into clinical trials (see story). RNAa is based on short duplex RNAs, known as small activating RNAs, which up-regulate targeted endogenous genes, increasing production of therapeutic proteins silenced in diseased cells. Ractigen will also scale-up its oligonucleotide manufacturing capabilities. One year ago, Ractigen completed an $18 million Series A round. The A+ round was led by SDIC Venture Capital. The company is located in the Industry Park of Life and Health Science of Rudong, Jiangsu Province.  

Ignis Therapeutics, a Shanghai CNS company, acquired China rights from NeuroSigma of Los Angeles to a device that treats attention deficit hyperactivity disorder (ADHD) (see story). The Monarch eTNS System is based on external trigeminal nerve stimulation (eTNS). In the US, the device is approved for use in children with ADHD aged 7 to 12. NeuroSigma believes it may also be an effective treatment for depression and epilepsy. In 2021, Ignis was formed by South Korea's SK Biopharma to bring SK's CNS drug assets to China. It raised $180 million in an A round led by 6 Dimensions.  

EdiGene, a Beijing gene-editing company, announced a translational R&D collaboration with the Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and a platform technology (see story). The Haihe Lab focuses on fundamental research and translation in the cell ecosystem. Under the agreement, both parties will work together to develop hematopoietic stem cell regenerative therapies, novel genetically-modified hematopoietic stem cell therapies and innovative biomarkers for quality control of stem cell production. EdiGene has started China trials of its lead candidate, the first gene-edited hematopoietic stem cell therapy approved for China tests. 

Company News 

Shanghai I-Mab (NSDQ: IMAB) partnered with Hangzhou Qiantang New Area to build a manufacturing facility for its transition to commercialization (see story). I-Mab Hangzhou's initial product will be felzartamab, an anti-CD38 monoclonal antibody that has completed Phase III trials as a third-line treatment for multiple myeloma. The facility has already started pilot manufacturing operations including process development and analytical laboratories. Construction of an 80,000-square-meter manufacturing facility was completed in December 2021.  

Suzhou ImmVira has started pilot-scale manufacturing of its custom-designed next-gen oncolytic herpes simplex virus (oHSV) vector, which ImmVira will use to  enable CAR-T treatment of solid tumor cancers (see story). The vector will cause the tumor to express antigens that a CAR-T therapy will recognize. ImmVira will use the herpes simplex virus (oHSV) vectors to conduct pharmacological and toxicological studies for IND filings in the US and China. The company is developing its own CAR-T therapies to follow the oHSV product and is seeking partners for additional candidates.  

Trials and Approvals 

Applied Pharmaceutical Science has been approved to start US trials of its next-gen selective RET inhibitor, a proposed therapy for solid tumor RET cancers (see story). APS, a Beijing-Philadelphia company, is a precision therapy cancer biotech that develops cancer therapies based on cancer genetics, protein structure/function, synthetic medicinal chemistry, and verification via experiment and computation. The trial will enroll solid tumor patients with RET gene alterations or resistance to first-gen RET. 

Disclosure: none.