Deals and Financings

Jiangsu Chia Tai Fenghai Pharma (CTFH) signed a $200 million agreement with Insilico Medicine, an AI drug discovery company headquartered in Hong Kong, to discover two triple-negative breast cancer candidates, aiming at previously undruggable targets (see story). In September, Insilico raised $37 million from China investors after publishing an article in Nature Biotechnology showing its AI-platform could generate, synthesize and preclinically validate a series of compounds in 46 days. CTFH, which said it hopes the collaboration will become a long-term relationship, will make milestone payments and pay royalties on the candidates.

China Grand Pharma (HK:512) and its US affiliate, Sirtex Medical, invested $30 million into OncoSec Medical (NSDQ: ONCS), a New Jersey immunotherapy company (see story). CGP will own 53% of OncoSec after the transaction and will have China and Asian rights to OncoSec's TAVO (tavokinogene telseplasmid), a device that delivers DNA-based interleukin-12 (IL-12) directly into tumors, stimulating an immune response. OncoSec will use the funds to complete two ongoing TAVO clinical trials in combination with Merck's Keytruda®, including trials in melanoma and triple-negative breast cancer.

Beijing Gene+ Technology closed a $28 million B round led by Co-Stone to advance its oncology gene testing services (see story). The company's $30 million A round, completed in 2016, was led by BGI Group, China's largest genetics sequencing company, which also contributed to the B round along with previous investor Green Pine Capital Partners and Volcanics Venture. Founded in 2015 Gene+ offers tests that assess an individual's genetic risk for developing cancer as well as early detection services and precision medicine guidance.

In a partnership, Chipscreen Biosciences (SHA: 688321) of Shenzhen signed up Beijing's Novogene to develop companion diagnostics (CDx) for Chipscreen's cancer drug Chiauranib (see story) Chiauranib, which was approved in 2014, targets molecules in three signaling pathways, giving the candidate three separate mechanisms: inhibiting angiogenesis and mitosis and modifying the tumor microenvironment. The company plans to test CS2164 in new indications including ovarian, lung and liver cancers as well as non-Hodgkin's lymphoma. In August, Chipscreen was the first China biopharma to IPO on Shanghai's new STAR Exchange, raising $148 million.

Cellular Biomedicine (NSDQ: CBMG), a US-China biopharma, signed a lease to build a R&D facility in Maryland that will support early US trials of its CAR-T immunotherapy candidates (see story). CBMG has already started China Phase I trials of its CAR-T treatment that was developed in its Shanghai and Beijing R&D facilities. The company focuses on immunotherapies for oncology indications and stem cell treatments for degenerative conditions. It said the US site will facilitate partnerships and innovation along with US development of its products.

Trials and Approvals

Harbour BioMed (HBM) completed a China Phase II trial of HBM9036 (tanfanercept), a novel TNF receptor-1 fragment indicated for moderate-to-severe Dry-Eye-Disease (see story). In 2017, Harbour in-licensed China rights to the candidate in a two-drug deal from Korea's HanAll, which also included a treatment for pathogenic IgG-mediated autoimmune diseases. Harbour pointed out that OTC dry eye drops alleviate the symptoms of DED, but do not address the underlying inflammation. Harbour is headquartered in Boston, with operations in the Netherlands and Shanghai.

Kangpu Biopharma of Shanghai completed a first-in-human US Phase I trial of KPG-818, a small molecule immunomodulator based on the CRBN E3 ubiquitin ligase complex (see story). Kangpu expects KPG-818 will be an effective treatment for systemic lupus erythematosus (SLE) and hematological malignancies. In the Phase I trial, which was conducted in healthy participants, KPG-818 did not show any safety or tolerability problems. Kangpu, formed by returnees, is developing novel small molecule drugs for cancer, autoimmune and inflammatory disorders.

Innovent Biologics (HK: 01801) of Suzhou and Hutchison China MediTech (Chi-Med) (AIM/NSDQ: HCM) expanded their global collaboration to test a combination of Innovent's approved PD-1 drug, Tyvyt®, and Chi-Med's surufatinib (see story). The China-US tests will enroll patients with solid tumors. Surufatinib is a novel inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor 1 (FGFR1) and colony stimulating factor-1 receptor (CSF-1R). Previously, Innovent and Chi-Med agreed to test a combination of Tyvyt and Chi-Med's approved VEGFR inhibitor, fruquintinib.

Hutchison China MediTech (Chi-Med) (AIM/NSDQ: HCM) started a global Phase I/Ib study of its novel small molecule Syk inhibitor in patients with relapsed or refractory lymphoma (see story). The primary endpoints of the trial are safety and tolerability, though PK and objective response rates will also be monitored. Chi-Med expects that HMPL-523, a second-gen Syk inhibitor, will cause fewer safety problems than first-gen candidates. In an earlier Australian trial, HMPL-523 showed an acceptable safety profile. The candidate is also being tested in a China Phase I trial in patients with immune thrombocytopenia.

Company News

BJ Bioscience, a Hangzhou novel drug developer, has signed up CMAB Biopharma (Suzhou) to provide CMC research and manufacturing services for BJ-005, its bi-functional mAb intended for cancer indications (see story). CMAB will develop BJ-005 to support INDs in China and the US. Previously, BJ Bio has submitted an IND for its lead candidate, BJ-105, a fusion IL-12 mAb, also targeting cancer. The company said it wants to focus on innovative discovery, while it uses CMAB's experience in CMC and manufacturing to advance BJ-005.

Changsheng Biotechnology (SHZ: 002680), a Jilin vaccine biotech, will be delisted from the Shenzhen Stock Exchange one year after the company was discovered to be selling substandard vaccines (see story). Investigators found that Changsheng Bio fabricated records for an inspection and that its DPT (diphtheria, pertussis, and tetanus) vaccine for children was largely ineffective. China has declared war on drug/vaccine companies that sell substandard products -- regulators want to build confidence in domestic drug products -- and the delisting shows the country's resolve.

Disclosure: none.