publication date: Jul 3, 2021
author/source: Richard Daverman, PhD
Deals and Financings
BeiGene (NSDQ: BGNE; HK: 06160) of Beijing has been approved to stage a $3 billion IPO on the Shanghai Star Stock Exchange (see story). It will be the first Chinese biopharma to be listed in Shanghai, Hong Kong and the US. According to a Caixin report, BeiGene’s prospectus meets the listing conditions and information disclosure requirements of the STAR Market, but regulators asked BeiGene to explain how it will protect the interests of domestic shareholders. Founded in 2010, BeiGene develops molecularly targeted and immuno-oncology drug candidates to treat cancer.
Nanjing Simcere Pharma (HK: 2096) in-licensed a clinical-stage therapy for Alzheimer's disease from Germany's Vivoryon Therapeutics (AM: VVY) (see story). Vivoryon's neurotoxic amyloid species N3pE (pGlu-Abeta) candidate showed a promising ability to restore memory function in a Phase IIa trial conducted among early stage AD patients. Simcere made an upfront payment plus agreed to pay up to $565 million in milestones. The agreement includes varoglutamstat, Vivoryon's N3pE amyloid-targeting oral small molecule glutaminyl cyclase inhibitor, which the company believes has disease-modifying potential for AD, along with a preclinical monoclonal N3pE-antibody.
HutchMed (NASDQ/AIM: HCM; HK: 13), a Shanghai novel drug company, completed a $537 million IPO on the Hong Kong exchange, its third global listing (see story). The company is also listed on London's AIM exchange and NASDAQ. HutchMed (formerly Hutchison Chi-Med) has three novel approved oncology drugs in China, and it has seven more candidates in development. Following the IPO, its shares rose 20% ($6.49) to $40.02 in early trading on NASDAQ, giving the company a market capitalization of $6 billion.
Eight Roads, Fidelity's global investment arm, launched its fifth China healthcare fund for China, Eight Roads China Healthcare Fund V with $400 million to invest (see story). As with its earlier funds, Eight Roads intends to further its core strategy of making healthcare investments that develop all facets of China's healthcare ecosystem and address critical diseases. Specifically, Eight Roads will focus on early-stage opportunities in the healthcare industry, including therapeutics, med tech, healthcare services and healthcare IT/digital health.
Suzhou Innovent Bio (HK: 01801) signed a non-exclusive, target-specific license to use antibody-drug conjugate technology developed by Amsterdam's Synaffix (see story). Synaffix will employ its programs to create an ADC candidate based on one of Innovent's antibodies. Synaffix will manufacture components that are specifically related to its proprietary technologies, but Innovent will be responsible for the rest of the product's development. Synaffix is eligible to receive upfront, potential milestone and royalty payments, though details were not disclosed.
ArriVent Biopharma, a Philadelphia startup that intends to bring China novel drugs to global markets, raised up to $150 million in a Series A financing (see story). The company has in-licensed ex-China rights to a potentially best-in-class epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), furmonertinib, from Shanghai's Allist Pharma. ArriVent continues the trend of taking China products into western markets. The financing provides $90 million to ArriVent upfront with the rest contingent on completing milestones. The funding -- all of which was from China VCs -- was led by Hillhouse Capital.
Zentalis Pharma (NSDQ: ZNTL), a US-China biopharma, closed a $150 million secondary offering to advance its small molecule cancer portfolio (see story). One year ago, Zentalis formed a a Shanghai subsidiary, Zentera Therapeutics, with initial funding of $20 million to develop three of its candidates in China. Zentalis owns a majority stake in the JV. A clinical stage company, Zentalis says its candidates target fundamental biological pathways of cancers. Zentalis is headquartered in New York City with labs in San Diego.
Sirnaomics, a Mayland-Suzhou biopharma developing RNAi therapies, closed a $105 million Series E (see story). The company is developing novel RNAi therapeutics that treat cancer, fibrosis diseases, metabolic diseases and viral infections. Sirnaomics' two lead candidates, STP705 and STP707, are dual targeting siRNA therapeutics against TGF-β1 and COX-2 for both local and systemic administration for cancer and fibrotic diseases. The E round was co-led by long-time investor Rotating Boulder Fund of China, plus new new investors Walvax Biotech and Sunshine Riverhead Capital.
Denovo Biopharma acquired global rights to an Alzheimer's disease candidate from H. Lundbeck, a Denmark neurological biopharma (see story). The candidate, idalopirdine, is an oral antagonist of the serotonin (5-HT6) receptor that failed its Phase III trial in AD. Denovo, a Hangzhou-San Diego precision medicine company, will use its proprietary biomarker platform to search for pharmacogenomic predictors of idalopirdine's (DB109) efficacy in specific populations. Terms of the agreement were not disclosed.
Trials and Approvals
Shanghai I-Mab (NSDQ: IMAB) announced it has achieved several clinical milestones in its portfolio of 4-1BB bispecific antibodies (see story). I-Mab's lead bi-specific antibody assets are undergoing clinical development in the US. The first patient was dosed in a US Phase I clinical trial of TJ-CD4B/ABL111 in patients with advanced or metastatic solid tumors. China sites will join the dose expansion part of the trial. Results from TJ-L14B/ABL503 preclinical studies showed improved anti-tumor activity over 4-1BB and PD-L1 mAbs as single agents alone or in combination.
Pulnovo Medical, a Nanjing medical device company, has completed enrollment in a China trial of its PADN® device, which ablates the sympathetic nerve to treat pulmonary hypertension, a disease that is difficult to diagnose and treat (see story). The device uses a novel multi-electrode ring tip to dispense the radiofrequency for the ablation. The ablation is designed to cause percutaneous pulmonary artery denervation, lowering pulmonary hypertension. The US FDA granted the device breakthrough designation in 2021.
Neurophth Biotech, a Wuhan-San Diego gene therapy company, dosed the first patient in a China trial of a therapy for Leber hereditary optic neuropathy (LHON), which causes blindness in adult patients (see story). The Phase I/II/III trial will evaluate the safety, tolerability and efficacy of a recombinant adeno-associated virus vector 2 carrying the NADH-dehydrogenase subunit 4 (ND4) gene. The disease currently has no cure. The safety and efficacy of ND4 gene therapy have been shown in three investigator-initiated trials with clinical durability of up to 90 months.