Deals and Financings

Ping An, a China insurance company, announced a $311 million agreement with Japan's Shionogi to develop new drugs for infectious diseases and CNS needs based on Ping An's lifestyle data (see story). For its $311 million, Ping An will receive a 2% stake in Shionogi shares. The two companies will form a JV (51% owned by Shionogi), headquartered in Hong Kong, to develop the drugs. Shionogi said $120 million would be allocated to in-license products, while $160 million would develop new products, which will include novel, generic and over-the-counter drugs.

Nanjing Legend Biotech, a subsidiary of GenScript (HK: 1548; OTC: GNNSF), raised $150 million in a pre-IPO round from Hudson Bay Capital, J&J Development (see story), Lilly Asia Ventures, Vivo Capital, RA Capital and others. One month ago, GenScript announced it was spinning off Legend so that it can stage an IPO on a US exchange. The $150 million can also be considered an A round, because Legend has built its business on support from GenScript and a $350 million upfront fee that J&J/Janssen paid to partner Legend's CD38 CAR-T candidate in 2017.

Ocumension, a Hong Kong ophthalmology company, partnered with Japan's SanBio (TSE: 4592) to develop novel stem cell therapies for ophthalmic diseases in an agreement worth up to $77 million (see story). The two companies will work together to develop SanBio’s proprietary modified mesenchymal stem cell candidates to treat retinitis pigmentosa, dry age-related macular degeneration and optic neuritis. Ocumension will pay $6 million upfront with the remaining development costs split evenly between the companies. Ocumension, which will also be responsible for $71 million in milestones and China clinical trials, will own China rights to the candidates for ophthalmic indications.

Genechem, a Shanghai biotech CRO/CMO, raised $56 million in a Series C financing to support its innovative services (see story). The company aims to solve R&D difficulties for innovative drugs, especially for diseases with high incidence in China. Its services include discovery and preclinical, bioanalytical, genomic and API/biologics production. Founded in 2002, Genechem is located in Shanghai's Zhengjiang Hi-Tech Park.

Shanghai ZhenGe Biotech, a China CDMO, completed a $51 million Series A financing round led by Shanghai-based healthcare investment firm Lyfe Capital (see story). The company will use the proceeds for additional hires and to expand its Shanghai R&D center, build a GMP production base in the Shanghai Pilot Free Trade Zone (a production facility for macromolecular drugs, growth media and ADC drugs), and expand its US lab. Also participating in the A round were IDG Capital, Cowin Capital, Korea Investment Partners, GT Capital and Shanghai International Group.

HK Tainuo and Jiangsu Tainuo (HK: 1093) signed a $42.5 million agreement to acquire greater China rights to a treatment for knee osteoarthritis pain from Flexion Therapeutics (NSDQ: FLXN) of the US (see story). Zilretta was approved in the US in 2017 as an extended-release intra-articular therapy for patients with knee pain. HK Tainuo will make an upfront payment of $10 million to Flexion and be responsible for up to $32.5 million in milestones along with China development activities for Zilretta. Tainuo is a subsidiary of China Shijiazhuang Pharma.

Rgenta Therapeutics, a Cambridge, Mass. biotech startup, raised $20 million in seed funding from a syndicate that includes China investors (see story). The company is developing small molecule candidates that target RNA regulation and splicing of disease-causing genes in oncology and neurological disorders. The targets are undruggable by traditional approaches, Rgenta says. The funding was co-led by Boehringer Ingelheim Venture Fund and Matrix Partners China, and it also included Hangzhou Kaitai Capital and Legend Star Fund, an offshoot of China's Lenovo Group.

Guangzhou Targene Biotech, a company developing early diagnosis reagents and testing services, closed a $14 million Series A round, led by BGI Co-win (see story). Targene develops liquid biopsies, gene methylation and other molecular diagnostic technologies for testing and early diagnosis of cancer. Its technology includes real-time, fluorescence-based quantitative PCR, fluorescence in situ hybridization (FISH) and low-density biochips. Founded in 2016, BGI Co-Win is the VC arm of Shenzhen's BGI Genomics.

Shanghai Junshi Biosciences (HK: 1877) announced it has been approved to list on the Shanghai STAR Exchange (see story). In late 2018, Junshi completed a $394 million IPO in Hong Kong, and the company's shares have climbed about 50% in the 15 months since then. Just after the Hong Kong IPO, Junshi was approved to market Tuoyi, the first China-developed anti-PD-1 drug as a second-line treatment for melanoma. It is the first domestic PD-1 approved in China. Tuoyi produced $110 million in revenues from its February 2019 launch until the end of the year.

Coronavirus Outbreak

Ansun, a San Diego clinical-stage biopharma, announced positive early results from a China trial using its antiviral to treat COVID-19 (see story). In four patients, two are stable and no longer require oxygen, one was virus free and the last remains in treatment while showing positive trends. DAS181 is an inhaled recombinant sialidase protein that cleaves sialic acid located on the surface of epithelial cells in the respiratory tract. Because many viruses use sialic acid as a receptor to infect epithelial cells, DAS181 is expected to block virus entry and prevent viral infection.

Trials and Approvals

BeyondSpring (NSDQ: BYSI), a New York City biopharma that develops drugs for the US and China, has started a rolling submission of a China NDA for Plinabulin to treat chemotherapy-induced neutropenia (see story). The Phase III trials tested Plinabulin compared to Neulasta, a granulocyte-colony stimulating factor, or together with Neulasta and compared to Neulasta alone. GSCFs have been the standard of care for CIN for 30 years. BeyondSpring expects to submit an NDA in the US for the same indication in the second half of 2020.

Hutchison China MediTech (Chi-Med) (NSDQ/AIM: HCM) started a China Phase II trial of HMPL-453, a novel small molecule inhibitor of fibroblast growth factor receptors (FGFR) (see story). Chi-Med says HMPL-453 is aimed at solid tumors. The trial is a single-arm, multi-center, open-label study, evaluating the efficacy, safety and pharmacokinetics of HMPL-453 in advanced malignant mesothelioma patients who have failed at least one line of systemic therapy. Chi-Med said the candidate showed better potency and kinase selectivity in pre-clinical trials than other drugs in its class.

Gracell Biotechnologies of Suzhou announced its IND to test GC007g, a donor-derived anti-CD19 CAR-T candidate, was accepted for review by China authorities (see story). GC007g is an allogenic CAR-T therapy being developed for relapsed/refractory B-ALL patients. It uses healthy T cells from human leukocyte antigen (HLA) matching donors, with potentially better T cell fitness and possibly higher efficacy than a patient's own T cells. A CAR-T company, Gracell's novel products address CAR-T drawbacks including high production costs, a lengthy manufacturing process, a lack of off-the-shelf therapies and inefficacy against solid tumors.

Company News

GoBroad Healthcare Group has broken ground for a Beijing 500-bed research hospital in Life Science Park, a section of Future Science Park in Beijing's Changping district (see story). The project is funded by Hillhouse Capital, a Beijing VC/PE company, and its medical research arm, GoBroad Healthcare Group, along with the government of Changping district. Upon completion, the 100,000-square meter facility will implement translational medicine research, with the goal of reducing the time to market for new drugs. GoBroad described its purpose as forming a closed-loop system that will tie in with Hillhouse's pharma investments.

Seneca Bio (NSDQ: SNCA), a Maryland biopharma, completed its new Suzhou cell manufacturing facility that will manufacture the company's stem cell therapy for ischemic stroke (see story). NSI-566 is currently being tested in a non-GCP compliant Phase II trial at the BaYi Brain Hospital in Beijing. A spinal-cord derived neural stem cell line. NSI-566 is being investigated as a treatment for stroke, Amyotrophic Lateral Sclerosis (ALS), and chronic spinal cord injury. Seneca was previously known as Neuralstem.

Suzhou Alphamab Oncology (HK: 9966) and 3D Medicines (Beijing) will market KN035 (envafolimab), their partnered PD-L1 checkpoint inhibitor, through Simcere Pharma (see story). Simcere will be paid a marketing fee. Alphamab discovered the candidate and will manufacturer it. 3DMed is overseeing KN035's clinical development, registration and commercialization. Simcere will market KN035 in mainland China after the product's registration. In 2016, Alphamab and 3DMed formed a co-development partnership for KN035, which is in a China Phase III trial for advanced biliary tract cancer (BTC).

Disclosure: none.