Deals and Financings
NJCTTQ, a Nanjing biopharma, announced a deal worth up to $4 billion to co-develop bispecific immunotherapies discovered by Abpro of Massachusetts. NJCTTQ will have China and Thai rights to multiple immunotherapies discovered by Abpro's DiversImmune antibody discovery platform for T-cell engagement. NJCTTQ will make a $60 million near-term payment to Abpro to underwrite R&D expenses and be responsible for the remainder in milestones and royalties. NJCTTQ is a subsidiary of CTTQ Pharma, a division of Sino Biopharm (HK: 1170).
Suzhou CStone Pharma (HK: 2616) raised $285 million in an Hong Kong IPO that valued the oncology company at $1.5 billion. The IPO was priced at the middle of the range, and the stock rose 7% in the first trading session. Just 2.5 years old, CStone has built a portfolio of 14 oncology drugs through novel drug discovery and in-licensings. The company's three core products are IO candidates - PD-1, PD-L1 and CTLA-4 antibodies - which will be paired with other CStone assets as combination therapies.
Gracell Biotechnologies, a Suzhou immune cell gene therapy company, has completed an $85 million series B funding led by Temasek. Gracell is focused on developing best-in-class cellular medicines for cancer patients by addressing the complex manufacture and high cost of cellular gene therapeutics. With the new funds, it plans to start clinical trials with several of its next-gen immune cell gene therapy drug candidates. Lilly Asia Ventures, Kington Capital, King Star Capital and Chengdu Miaoji also participated in the funding.
Aslan Pharma (ASLN; TPEx: 6497) of Singapore out-licensed South Korean rights for a bile-duct oncology candidate to South Korea's BioGenetics in a $13 million deal. BioGenetics will make a $2 million upfront payment and could pay up to $11 million in sales and development milestones. The two companies will collaborate to commercialize varlitinib, a small-molecule inhibitor of human epidermal growth factor, in all indications in South Korea. In H2 of 2019, Aslan expects to report topline data from a global pivotal trial of varlitinib in second-line biliary tract cancer.
Beijing Surgerii Technology completed a Series A financing of "millions of RMB" led by Shunwei Capital, an early and mid-stage investor with a focus on the internet. Founded in 2014, Surgerii is developing a third-gen robotic surgery device based on continuum technology. Continuum technology requires only a single incision and provides a probe with flexible curvature, which allows the probe to follow the winding paths of blood vessels more easily.
Trials and Approvals
Shanghai Henlius Biotech's biosimilar to Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) Rituxan has been approved by China's NMPA, the first biosimilar approved in China. Shanghai Henlius, which was set up in 2010 as a JV between Shanghai Fosun Pharma (HK: 02196: SHA: 600196) and US-based Henlius, focuses on novel and biosimilar mAbs. In a China Phase III trial, the Henlius biosimilar showed it matched the efficacy of the Roche original in patients with CD20-positive non-Hodgkin lymphoma. Ironically, Rituxan was the first monoclonal antibody approved for US use as a cancer treatment.
Innovent Biologics (HK: 1801) of Suzhou has dosed the first patient in a China Phase II/III combination trial that pairs Tyvyt, Innovent's approved anti-PD-1 mAb, with its Avastin biosimilar as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The ORIENT-32 trial will enroll 566 patients with HCC. It will compare the regimen to Bayer's Nexavar, the current standard of care for liver cancer. The new test follows a Phase Ib clinical trial of Tyvyt as a monotherapy in patients with advanced HCC.
Xynomic Pharma, a US-Shanghai in-licensing company, has dosed the first South Korean patient as part of the company's global pivotal Phase III trial of abexinostat, a novel histone deacetylase (HDAC) inhibitor. Xynomic has already started the US arm of the global trial. The company expects to begin similar trials in Europe and China in the first half of 2019. Abexinostat is being tested in combination with pazopanib as a first- or second-line treatment for renal cell carcinoma (RCC). In September 2018, Xynomic completed a reverse merger with Bison Capital Acquisition (NASDAQ:BCAC) at a $450 million valuation.
Government and Regulatory
China issued a draft of new rules that regulate initial clinical trial approvals of high-risk cell and molecular therapies, establishing fines and criminal penalties for individuals and institutions that do not follow the policies. After last year's CRISPR scandal, gene editing and gene transfer figure prominently in the new rules. The new regulations create a two-tier system that distinguishes between high and low-risk technologies. Initially, clinical trial applications will be reviewed by provincial authorities. High risk technologies will be sent to the National Health Commission for a final review, all within the 60-day maximum already in place for China clinical trial reviews.
Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.