Week In Review: CStone Acquires China Rights To Leukemia Drug In $424 Million Deal

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Includes: AGIO, AMRS, ESALY, LGND, NVS, ONCY, PCRX, WXXWY, ZLAB
by: ChinaBio Today

Deals and Financings

CStone Pharma of Suzhou acquired rights to a novel cancer drug from Agios (NASDAQ:AGIO), a Boston area pharma, in a deal worth up to $424 million (see story). CStone will have rights to ivosidenib in greater China. It will initially target acute myeloid leukemia (AML) and cholangiocarcinoma, although the companies believe ivosidenib has potential efficacy against many cancer indications including glioma. Ivosidenib is a first-in-class, oral, targeted inhibitor of the mutant isocitrate dehydrogenase-1 (IDH1) enzyme.

China's I-Mab Biopharma completed a $220 million Series C round led by Hony Capital. It was, according to the company, one of the largest C rounds ever for an innovative China biotech. I-Mab was formed in early 2017 when C-Bridge Capital and Tasly Pharma merged two China entities, Third Venture Biotech and Tasgen Bio, and invested $150 million in the consolidated company. At the time, I-Mab was said to have 12 antibody drug candidates.

Adlai Nortye (TSX:ONC), a Hangzhou biopharma, closed a $50 million Series B round led by Yuanming Capital. Adlai Nortye describes itself as a science-led discovery and in-licensing biopharma focused on new drugs for cancer and metabolic diseases. So far, it has three announced molecules of its own, currently in pre-clinical development, and it has in-licensed rights to two clinical-stage immuno-oncology products - one from Canada's Oncolytics Biotech (ONCYF) and the other from Eisai (OTCPK:ESALY) (TYO:4523) of Japan.

WuXi Biologics (OTCPK:WXXWY) (HK:2269) paid San Diego's Ligand Pharma (NASDAQ:LGND) $47 million in a single payment to renegotiate its agreement for use of Ligand's OmniAb platform (see story). Because of the payment, WuXi will not have to pay a per-use charge for the OmniAb platform. WuXi Bio said the change will increase the number of its biologic CRO clients who use OmniAb. In 2012, WuXi obtained rights to use the transgenic animal platform. Under the new contract, Ligand will still be eligible to earn the same royalties on developed products as before - only the initial payment is changed.

Nuance Biotech of Shanghai closed a $35 million B round funding that it will use for its China in-licensing program. Led by C-Bridge, the round includes $15 million ear-marked for Nuance's recent acquisition of China rights to Pacira's (NASDAQ:PCRX) Exparel®, a non-opioid treatment for long-lasting pain following surgery. C-Bridge, which initiated the $58 million Nuance-Pacira deal, said its relationship with Nuance is a "unique funding model" for building a China pharma company. C-Bridge will use its global network to find products that Nuance will license for China's market.

HaploX Biotechnology of Shenzhen has raised "several hundred of millions of RMB" to support its cancer liquid biopsy products. The B round was led by Shenzhen Capital Group, a government-backed VC, and seems to be at least as large as HaploX's previous $32 million A round in late 2017. A gene sequencing company, HaploX offers early cancer screening and genetic tests for personalized cancer medicines.

Amyris (NASDAQ:AMRS), a Bay Area bioscience company, will form a JV with Shenzhen's BGI Genomics to develop human microbiome products for China (see story). Amyris develops fermentation processes that provide health and beauty products as well as synthetic artemisinin for malaria. The JV will combine Amyris' fermentation capabilities with BGI's gene sequencing expertise. Ultimately, the JV aims to develop products that promote a healthy microbiome based on natural products, including TCM-based ingredients that are sustainably produced by Amyris' clean fermentation technology.

Shanghai's Everest Medicines acquired global rights to a novel Novartis (NYSE:NVS) liver cancer treatment. FGF401, a FGFR4 (fibroblast growth factor receptor 4) kinase inhibitor, is currently in Phase I/II clinical trials across the US, Europe and Asia as a potential treatment for hepatocellular carcinoma and other solid tumors positive for FGFR4 and KLB (klotho beta) expression. Founded last year, Everest began operations with a $50 million investment from C-Bridge Capital, the first tranche of an initial round expected to raise $130 million.

Ascletis BioScience of Beijing has signed a strategic cooperation agreement with CR Pharmaceutical Commercial Group (HK:3320) to launch Ganovo® (danoprevir). Ganovo, a direct-acting anti-viral agent, is Ascletis' first approved product and the first direct-acting anti-viral HCV treatment approved in China. The approval was announced earlier this month. In May, Ascletis became the first China pharma to apply for a Hong Kong IPO under new rules allowing pre-revenue pharmas to stage their initial public offerings on the exchange. The IPO is expected later this year.

Harbour BioMed has formed an "initial strategic" collaboration with WuXi Biologics (HK:2269) to develop clinical trial supplies of Harbour's leading HCAb antibody. Harbour, headquartered in the Boston area with a development facility in Shanghai, launched 18 months ago to develop IO and immunology therapies. Harbour BioMed was funded with $50 million in startup capital and included an existing Dutch discovery company, Harbour Antibodies BV. Harbour and WuXi Biologics will develop the HCAb antibody candidate for China and other global markets.

Trials and Approvals

Zai Lab (NASDAQ:ZLAB) of Shanghai has dosed the first patient in a China Phase III registration trial of ZL-2306 (niraparib) as a first-line maintenance therapy for platinum-responsive ovarian cancer. Niraparib is an oral, once-daily PARP 1/2 inhibitor that Zai believes could be a first-in-class Category 1 drug in China for treating multiple solid tumor types. Zai also expects to begin a Phase III trial of niraparib for small cell lung cancer by mid-2018.

Tokyo's Solasia Pharma (TSE:4597) reported China's Center for Drug Evaluation has completed a review of the New Drug Approval filing for Sancuso®, a granisetron transdermal patch used to treat nausea and vomiting caused by chemotherapy. The CDE accepted the filing and passed it on to the China National Drug Administration for approval. In 2008, Solasia in-licensed China rights to Sancuso, an extended-use product intended to be left in place for five days, from Strakan, a British company.

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