Deals and Financings

Shenzhen HighTide Therapeutics filed for an IPO on the Hong Kong Exchange to develop a portfolio of novel multifunctional drugs for metabolic and digestive diseases (see story). The company’s lead candidate is berberine ursodeoxycholate, a gut-liver anti-inflammatory metabolic modulator that targets multiple pathways. HTD1801 is being developed for nonalcoholic steatohepatitis (NASH), type 2 diabetes and three other indications. The company is developing five assets for nine indications. Founded in 2011, HighTide was originally backed by Hepalink and its Chairman/CEO, Dr. Liu. In January 2023, HighTide closed a $107 million Series C/C+ funding. 

Shanghai Fosun Pharma (SHA: 600196; HK: 02196) will partner with the International Finance Corp, a World Bank affiliate, to build a pharmaceutical production facility and distribution hub in the Ivory Coast for Africa (see story). The IFC will issue two loans worth a total of $107 million to help underwrite the cost. The project, which was launched in November 2022, will consist of three phases, ultimately building a manufacturing plant with the capacity to make 5 billion medicine tablets annually. Fosun said the new facilities will support better healthcare delivery in West Africa, especially for malaria and antibacterial medicines. 

Trials and Approvals

Chengdu WestVac Biopharma announced that its Trivalent COVID-19 vaccine targeting XBB variants was approved for emergency use in China (see story). The vaccine, named Coviccine®, is the first vaccine approved globally to target XBB variants. It was developed by WestVac Biopharma/West China Medical Center, Sichuan University. WestVac used an insect cell expression platform to construct the vector for Coviccine®, an XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell). The company worked with its subsidiary WestVac Biopharma (Guangzhou) to develop the vaccine. 

Suzhou Innovent (HK: 01801) and Nanjing’s IASO Bio presented positive long-term follow-up results of a Phase Ib/II trial of their partnered BCMA CAR T-cell therapy in relapsed and/or refractory multiple myeloma patients (see story). The data, which was released at the ASCO meeting, showed equecabtagene autoleucel achieved an overall response rate of 96%. 91% of the patients showed at least a very good partial response, and 74% had either a stringent complete response or a complete response. The enrolled patients, who had previously been treated with at least three rounds of treatment, were refractory to their previous therapy round. 

Legend Biotech (NASDAQ: LEGN), a Nanjing-New Jersey CAR-T company, announced positive results from a US Phase III trial of its lead drug, cilta-cel, as an earlier treatment for multiple myeloma (see story). The trial showed cilta-cel reduced disease progression by 74% compared to standard treatment in a trial that enrolled patients who had previously received one to three prior therapies. Cilta-cel is a BCMA autologous T-cell drug that shocked the world in 2017 with near 100% efficacy in multiple myeloma. It is already approved in China, the US and EU, though only after as many as four earlier treatment rounds. 

Shanghai iTabMed was approved to start China clinical trials of A-337, a CD3-activating bi-specific antibody targeting EpCAM, in patients with advanced solid tumors (see story). The company says EpCAM is up-regulated and over-expressed in many solid tumors. A-337 was developed using iTabMed’s immunotherapy antibody (iTab™) platform. iTab™ is a T cell engager platform for human CD3-activating bi- and tri-specific antibodies targeting tumor associated antigens. A-337 has a similar structure to its lead candidate, A-319, which has started Phase I trials for patients with liquid tumors. 

Shanghai Gracell Biotech (NSDQ: GRCL) reported its dual-targeting BCMA/CD19 FasTCAR-T candidate showed efficacy in heavily pre-treated patients with relapsed/refractory multiple myeloma (see story). The median duration of response was 37 months in patients who had previously received a median of five therapy rounds, and the median progression free survival was 38 months. FasTCAR-T, Gracell’s CAR-T technology, produces an autologous CAR-T treatment overnight instead of nearly a month. The single-arm, investigator-initiated trial enrolled 29 RRMM patients. Gracell released the data for GC012F, its lead candidate, in an abstract at the ASCO meeting. 

Shanghai Dizal (SHA: 688192) presented new data for its two leading assets at the recent ASCO convention: sunvozertinib, a selective EGFR TKI targeting a wide spectrum of EGFR mutations, and golidocitinib, a JAK1 inhibitor (see story). The company said sunvozertinib showed superior efficacy in treating advanced non-small cell lung cancer (NSCLC) and may prove to be Best-in-Class for NSCLC patients with EGFR Exon20ins mutations. The company has filed an NDA for Sunvozertinib in China. Golidocitinib showed promising tumor responses in relapsed or refractory peripheral T-cell lymphoma, an aggressive non-Hodgkin lymphoma. 

RemeGen (HK: 9995; SHA: 688331), a Yantai commercial-stage biotech, reported positive data from an early trial of its anti-HER2 ADC, disitamab vedotin, in combination with Junshi Bio’s PD-1 toripalimab for urothelial carcinoma (see story). The combination met its safety endpoints and showed an Objective Response Rate of 73.2% and Complete Response of 9.8%. In 2021, disitamab vedotin was approved to launch in China for gastric cancer, the first China-developed ADC to be approved. Also in 2021, RemeGen out-licensed ex-Asia rights for the drug to Seattle’s Seagen in a $2.8 billion agreement. 

Two western biopharmas, Germany’s BioNTech and US-based Merck, reported early results at ASCO for antibody drug conjugate therapeutics they in-licensed from China companies (see story). ADCs are currently biotech’s hottest drug development field, and the two companies each bolstered their pipelines with candidates from China biopharmas. BioNTech said DB-1303, its topoisomerase-1 inhibitor DC acquired from Shanghai DualityBio, showed encouraging improvement in HER2-positive breast cancer patients. Merck’s SKB264, an anti-TROP2 ADC in-licensed from Kelun-Biotech, was effective and safe for NSCLC patients in a Phase II trial. 

Disclosure: none.