Deals and Financings
Celltrion (KRX: 068270), a South Korea biopharma, plans to build a $513 million China biologics manufacturing facility in Wuhan. The company said the plant’s 120,000 liter capacity will make it the largest facility in China. Last summer, Celltrion announced it would form a China JV with Nan Fung Group of Hong Kong to develop three Celltrion biosimilars in China and build a manufacturing facility. That partnership fell apart. Now, Celltrion has signed a contract with Wuhan’s government to help finance its China operations. Celltrion Chairman Jung-jin Seo said the company plans to launch 18 biologic products in China by 2030.
Zai Lab (NASDAQ:ZLAB), a Shanghai novel commercial stage biopharma, raised $261 million in a secondary offering. The company reported it held $68.7 million of cash on September 30, 2019 and spent $110 million on R&D in the first nine months of last year, a near-doubling from 2018 due to new projects and ongoing clinical trials. Zai also announced it expects to submit a China NDA for ripretinib by mid-2020 to treat gastrointestinal stromal tumors. In late December, Zai reported China approval for Zezula, a PARP inhibitor and Zai’s first drug to launch in China.
Beijing Hengsheng Medical, a coronary medical device company, completed a $6 million Pre-A financing for its portfolio of drug-eluting stents, balloon catheters and accessories. The company has developed a drug-eluting balloon catheter with a proprietary “self-perfusion” technology that has begun late stage trials. HS Medical expects it will complete the clinical trial and apply for registration of the product in the first half of 2020, with a 2021 launch. The company says most balloon catheters in this class that are available in China come from foreign manufacturers.
China Medical System (HK: 0867) in-licensed China rights to a novel treatment for anemia from India’s Zydus Cadila (BSE: 532321). Desidustat is an inhibitor of hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) that is aimed at treating anemia in patients with chronic kidney disease, including both dialysis and non-dialysis patients. CMS will be responsible for development and commercialization, plus registration and manufacturing of the drug in China. Desidustat is currently in Phase III trials. Zydus will receive an upfront payment, regulatory and sales milestones, plus royalties, though specific amounts were not disclosed.
Oncologie, a Boston-Shanghai immunotherapy in-licensing company, will collaborate with Genialis of California to improve patient stratification techniques. The partnership will combine Genialis’ Expressions software platform and analytics IP with Oncologie’s clinical and translational expertise. The companies will develop earlier work focused on modeling gene expression signatures that predict the outcomes of gastric cancer treatments. Oncologie is developing four in-licensed cancer candidates, using patient selection to improve clinical results.
Trials and Approvals
Roche [SWX: ROG] (OTCQX:RHHBY) (OTCQX:RHHBF) announced Kadcyla has been approved in China as an adjuvant treatment for HER-2 positive breast cancer, the first antibody drug conjugate approved in China. In clinical trials, Kadcyla outperformed Herceptin, another Roche product that is now facing biosimilar competition. Kadcyla combines the HER2-targeting properties of Herceptin and the cytotoxic chemotherapy agent DM1. In a clinical trial, Kadcyla reduced the risk of invasive breast cancer recurrence or death from any cause by 50% compared to Herceptin. At three years, 88% of Kadcyla patients did not have a recurrence of their disease against 77% of Herceptin patients.
Ascletis Pharma (HK: 1672) was approved to start China trials of its in-licensed PD-L1 in patients with chronic hepatitis B. One year ago, Ascletis acquired China rights to ASC22 from Suzhou Alphamab for hepatitis B and other viral conditions. Ascletis expects ASC22, a first-in-class, subcutaneously administered PD-L1 antibody, will be effective against HBV, which renders the immune system ineffective through T cell exhaustion. Ascletis has two other potential HBV treatments in pre-clinical development plus a marketed drug, Pegasys. Ascletis plans to test ASC22 as a monotherapy and in combination with other drugs.
Suzhou’s TenNor Therapeutics received Orphan Drug Designation in the US for its novel antibacterial, TNP-2092, as a treatment for biofilm infections on prosthetic joints. The company says biofilm infections are extremely difficult to treat, often requiring surgical intervention plus prolonged antibiotic therapy. In November 2019, TenNor reported positive top-line results from a US Phase II trial of TNP-2092 in patients with acute bacterial skin and skin structure infection (ABSSSI). TenNor focuses on developing novel products for rare diseases associated with bacterial infections.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.