Deals and Financings

Qitan Technology, a Chengdu nanopore sequencing company, completed a $101 million Series C round to support its commercialized nanopore devices (see story). A nanopore device reads single DNA strands as they are moved through a membrane with nano-sized pores using electrolysis. Nanopore devices can complete ultra-long reads, and the technology offers lower cost sequencing with immediate results. One year ago, Qitan launched its first device, QNome-3841, the first Chinese firm and the second in the world to commercialize fourth-generation sequencing technology. The C round was led by Meituan, with participation from existing investors HuaGai Capital and BioTrack Capital. 

Simnova Biotherapeutics acquired China rights to novel CAR-T cell therapies developed by Orna Therapeutics, a Cambridge, MA biotech (see story). Simnova will have greater China rights to specific programs built on Orna's novel isCAR technology, including Orna's lead anti-CD19 in situ CAR (isCAR) program, ORN-101, which is based on Orna’s novel engineered circular RNA (oRNA) technology. Simnova, a Cambridge, MA-Shanghai company, is an affiliate of Simcere Investment Group and known as Xianbo Biotech in China. It develops off-the-shelf CAR-NK and BiTE-armed CAR-T cell therapies. 

Suzhou Evopoint Biosciences optioned out global rights (ex-China) for a pre-clinical ADC asset that targets solid tumor cancers to AmMax of Redwood City, CA (see story). The option specifies the licensing terms. The two companies intend to work together to complete an upcoming IND filing and design dose-escalating clinical studies. Evopoint has built a novel pipeline of six clinical and 15 pre-clinical candidates in oncology, anti-infectives and metabolic diseases. AmMax, which claims expertise in translational and clinical development, has built an oncology portfolio via licensing and partnerships. 

Trials and Approvals

Japan’s Takeda (TSE: 4502) was approved to launch Exkivity® (mobocertinib) in China to treat NSCLC patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutations (see story). In a Phase I/II trial, mobocertinib showed an overall response rate of 28% and a 15.8 median duration of response. The drug was administered as a second-line therapy to adult patients with locally advanced or metastatic NSCLC with the mutations. Mobocertinib is an oral tyrosine kinase inhibitor. Because the drug was reviewed under China’s Breakthrough Therapy program, Takeda must conduct a confirmatory trial of mobocertinib. 

Shanghai Dizal (SHA: 688192) announced its NDA for sunvozertinib was accepted in China for advanced NSCLC patients with epidermal growth factor receptor exon20ins mutations (see story). Sunvozertinib is an oral tyrosine kinase inhibitor that is designed to target EGFR exon20 insertion (exon20ins) mutations. In 2017, Dizal was formed as a JV between AstraZeneca and the China Future Industry Investment Fund, which contributed $132.5 million for a 50% share. The JV was founded with AstraZeneca assets after the company closed its Shanghai R&D facility. 

Shanghai Visen Pharma completed a Phase III trial of its novel therapy that restores parathyroid hormone in patients with hypoparathyroidism (HP), a rare disease (see story). The trial tested palopegteriparatide, a prodrug, in a double-blind, multi-center China trial. The company said HP is the only remaining endocrine deficiency condition that does not have a hormone replacement as standard treatment. Visen acquired rights to the drug from Copenhagen’s Ascendis Pharma, which formed Visen as a 50-50 JV with a syndicate of China VCs in 2018. Visen will now analyze the results of the Phase III trial. 

Bio4t2, a San Diego-Shanghai CAR-T company, dosed the first patient in a China trial of its CAR-T that targets the BT-001 antigen (see story). Overexpression of BT-001 antigen occurs in several types of solid tumors. The CAR-T (B4t2-001) was developed from Bio4t2's PrismCore™ platform, which combines algorithmic learning with and iterative CAR designs, generating genetically modified T cells with specific effector functions. The Phase 1 investigator-initiated study will assess the safety, tolerability, pharmacodynamic and preliminary efficacy of the autologous CAR-T as a single agent after lymphodepletion. 

Suzhou Innovent Bio (HK: 01801) started a China Phase III trial of a dual agonist therapy for patients with type 2 diabetes (see story). Mazdutide is a long-acting synthetic peptide that activates the GLP-1 and glucagon receptors, improving glucose tolerance and inducing weight loss. The candidate, which requires only once-weekly administration, is thought to mimic the effects of endogenous oxyntomodulin. Innovent in-licensed China rights to the drug from Lilly, its long-time partner for oncology drugs developed by Innovent. 

Harbour Biomed (HK: 02142) was cleared to start US Phase I trial of its novel, fully human mAb targeting B7H7 in patients with advanced solid tumors (see ). The company points out that B7H7 is part of the B7 family, which has provided many successful immunoncology drugs, including PD-L1 and CTLA-4 drugs. Harbour says the candidate does not overlap with PD-L1 expression in multiple tumor types, implying it targets a different immune evasion pathway than PD-L1, which could benefit PD-L1 negative/refractory patients. Harbour is headquartered in Cambridge, MA, with drug discovery operations in Rotterdam and an R&D lab in Suzhou. 

Disclosure: none.