Deals and Financings
Hutchison China MediTech (Chi-Med) [AIM:HCM] (NASDAQ:HCM) filed to IPO on the Hong Kong Exchange, following listings in London and on NASDAQ, where it has a market capitalization of over $4 billion (see story). In September 2018, Chi-Med was approved to launch fruquintinib in China, the first novel China-developed targeted treatment for cancer. The IPO is expected to raise between $300 million and $500 million. Chi-Med's parent, the conglomerate CK Hutchison, said it will reduce its Chi-Med holdings from 60% at present to less than 50% as part of the offering - a block that is worth at least $400 million.
BioSense, a New Jersey-Suzhou biopharma, acquired Greater China rights to a Rexahn (NYSEMKT:RNN) treatment for pancreatic cancer in a deal potentially worth $226 million (see story). BioSense, which will fund all development and commercialization costs for RX-3117 in Greater China, also agreed to start Phase II tests in up to three additional indications for RX-3117 not previously studied by Rexahn. RX-3117 is a novel oral small-molecule nucleoside compound that inhibits both DNA and RNA synthesis, which induces apoptosis.
Realbio Technology (RBT), a Shanghai genomic screening company, raised $15 million in a Series A+ funding. The company has a dual focus on colorectal and microbiome screening. RBT operates in three areas: REALGENE provides scientific research services; REALMED offers early detection of disease based on genomic sequencing including microbiome research; and REALAGR specializes in animal genomics. Founded in 2014, RBT has set up branches in Hangzhou, Qingdao, Guiyang and other places.
CASI (NASDAQ:CASI), a US in-licensing pharma with operations in China, acquired global rights to an investigational anti-CD38 immunotherapy from Black Belt Therapeutics of the UK (see story). CASI made a $5.5 million upfront payment and invested $2.2 million in Black Belt. It will also be responsible for milestone and royalty payments. Black Belt was spun out of Tusk when it was acquired by Roche (OTCQX:RHHBY) last year. The candidate TSK011010 is ready to submit an IND, with Phase I trials expected to start in late 2019 or early 2020.
JF Intelligent Healthcare Technology of Nanchang raised $5 million from GreyBird Ventures, a US firm, to support its efforts to develop intelligent technologies for better diagnoses at China community healthcare providers in tier three and four hospitals. Founded in 2015, JF Healthcare is particularly focused on medical image diagnosis, based on its own AI technology and offering telemedicine services. The company's offerings are used by more than 1,000 institutions.
I-Mab Biopharma of Shanghai formed a process development partnership with WuXi Biologics (OTCPK:WXXWY) (HK: 2269) to use WuXi Bio's expertise for CMC development of at least five programs and commercial manufacturing of at least one program for its proprietary monoclonal antibody, bispecific antibody and fusion protein pipelines. The two companies said the agreement is a significant expansion of their current relationship. No financial details of the partnership were disclosed. I-Mab is developing novel biologics for immuno-oncology and auto-immune diseases.
BioAtla, a San Diego-Beijing biotech, out-licensed greater China rights for two of its products to Himalaya Therapeutics SEZC, a majority owned subsidiary of BioAtla. BioAtla develops Conditionally Active Biologic (CAB) oncology treatments. In exchange for a minority equity position in Himalaya, Beijing Sinobioway contributed all of its China rights to existing and future BioAtla CAB candidates, which were part of a 2015 out-licensing from BioAtla. Previously, ChinaBio® Today called Himalaya a JV, which is incorrect. Sinobioway owns a minority stake in Himalaya, but is not active in managing the company.
Servier Pharma (Tianjin) signed a strategic cooperation agreement with Mitsubishi Tanabe Pharma to promote Mitsubishi's type 2 diabetes treatment drug Tenelia® (teneligliptin), a DPP-4 inhibitor, in mainland China. MTPC has completed the China Phase III clinical studies of Tenelia. The agreement was signed between Servier, a Paris headquartered biopharma, and Tianjin Tanabe Seiyaku, a JV formed by Tianjin Lisheng Pharma and Mitsubishi.
Golden Meditech (OTC:GMDTY) (HK:00801), a China medical device and healthcare management company, will collaborate with the Department of Biology of Hong Kong Baptist University to research the use of stem cells to treat neurodegenerative diseases. The company said HKBU is already researching stem cell therapy as a neurodegenerative treatment, with some results commercialized. Golden Meditech recently closed the sale of its 65% stake in China Cord Blood, a stem cell/cord blood storage company, for $860 million.
Trials and Approvals
CStone Pharma (HK:2616) of Shanghai has started a China Phase III of its anti-PD-L1 antibody (CS1001) as a first-line treatment for gastric cancer. The specific indications for the trial are gastric adenocarcinoma (GC) or gastroesophageal junction (GEJ) adenocarcinoma, which comprise over 90% of all gastric cancer cases. The multi-center, placebo-controlled trial will evaluate the efficacy and safety of CS1001 plus XELOX chemotherapy in patients with unresectable, locally advanced, or metastatic GC or GEJ adenocarcinoma.
Suzhou's CStone Pharma (HK:2616) was approved to start a bridging Phase I/II clinical trial in China of avapritinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). In June 2018, CStone acquired China rights to avapritinib and two other oral genomic-based potential cancer agents from Blueprint Medicine of the US in a deal worth up to $386 million. The goal of the Phase I/II bridging study is to allow CStone to participate in the global Phase III trial of the candidate.
Innovent Biologics (HK:01801) has dosed the first patient in a China Phase I trial of IBI302, a novel bi-specific fusion protein aimed at treating wet age-related macular degeneration (wet AMD). IBI302 targets vascular endothelial growth factor A (VEGF-A), the current standard of care, along with complement proteins that regulate the production of VEGF. Michael Yu, founder and CEO of Innovent, said IBI302 may improve wet AMD treatment, offering a less-frequent dosing regimen and better long-term outcomes because the candidate treats causes rather than effects of the disease.
GenScript Biotech, a China biopharma CDMO, has broken ground to build the GenScript-Legend Biotech Commercial Manufacturing Center in Zhenjiang, China. The facility will specialize in manufacturing plasmids and viruses for cell and gene therapies along with monoclonal antibodies. It will be capable of manufacturing both Phase III and commercial levels of production. Legend Biotech, which partnered its early-stage CAR-T therapy with Janssen Pharma in a package that included a $350 million upfront payment, is a subsidiary of GenScript. Legend is building a cell/gene therapy facility in the US as well.
In an exclusive interview with ChinaBio® Today, the leadership team of Apollomics, Dr. Guo-Liang Yu, co-founder and CEO, and Dr. Sanjeev Redkar, co-founder and president, described the company's execution of its innovative business plan. Apollomics focuses on bringing China-developed PD-1/PD-Li checkpoint inhibitors to the US market, the opposite of most young China biopharmas. The company seems almost to have anticipated the FDA's recent request for China biotechs to file NDAs in the US for their immunotherapies.
Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.