Deals and Financings

VistaGen (NSDQ: VTGN) of South San Francisco out-licensed China/Southeast Asia rights for a novel anxiety treatment to EverInsight Therapeutics, a China in-licensing company, in a $177 million agreement (see story). VistaGen's PH94B is a rapid-onset neurosteroid drug candidate for multiple anxiety-related disorders that is ready for Phase III trials. It has received US Fast Track designation to treat social anxiety disorder (SAD). The collaboration between the companies will support Phase III development and commercialization of PH94B in China/Asia markets. ChinaBio® advised VistaGen on the transaction.

Beijing's SinocellTech (SHA: 688520) completed a $181 million IPO on Shanghai's STAR Board and nearly tripled in price during its initial trading session (see story). The offering was priced at 25.64 RMB per share and ended its first session at 73.07 RMB, giving SinocellTech a market capitalization of nearly $4.5 billion. Sinocelltech is a biotech company that discovers and develops mAbs, recombinant proteins and vaccine products. The company has 23 products in its pipeline, including 21 novel differentiated drugs and two biosimilars.

Hangzhou Betta Pharma (SHZ: 300558) signed a $135 million deal to in-license China rights for two immunotherapies from Agenus (NSDQ: AGEN) of Massachusetts (see story). The two candidates are balstilimab, an anti-PD-1, expected to file for US approval this year, and zalifrelima, an anti-CTLA-4. They are being tested to treat refractory or metastatic cervical cancer. Betta will pay $35 million upfront ($15 million in cash and a $20 million equity investment) plus $100 million in potential milestones, and it will make royalty payments on net sales.

Hutchison China MediTech (Chi-Med) (NSDQ/AIM: HCM) announced a $100 million private placement of shares to General Atlantic, a growth equity investor (see story). General Atlantic will pay $25 each for the US-listed ADSs and has an 18-month option to invest another $100 million in Chi-Med at $30 per ADS. Chi-Med's previous closing price was $26.11. The company, which has a market cap of $3.2 billion and $220 million of cash, will use the proceeds to develop its novel seven-candidate portfolio.

Genor Biopharma, a Shanghai immunotherapy company, in-licensed rights to a CDK4/6 inhibitor designed to combine with other IO therapies (see story). Genor agreed to a $46 million deal with G1 (NSDQ: GTHX) Therapeutics of North Carolina to acquire Southeast Asia rights (ex-Japan) to lerociclib. The company will pay $6 million upfront and up to $40 million in milestones, plus royalties for the candidate. Genor expects to test lerociclib as a treatment for breast and lung cancers.

Simcha Therapeutics, a novel biotech using "directed evolution" to develop immunotherapies based on improved cytokines, raised $25 million in a Series A financing from two China investors -- WuXi AppTec Corporate Venture Fund and Sequoia Capital China -- along with Connecticut Innovations (see story). Simcha is based in New Haven, Connecticut. The company's lead program is based on a customized variant of interleukin-18 (IL-18), a cytokine designed to have more potent antitumor effects than its natural version.

Sophonix (Beijing Meilian Tyco Biotech) closed a $14 million Series B financing led by Zero2IPO Asset Management (see story). The company is developing chemiluminescence point-of-care-tests (POCT) for pathological diagnosis and immunodiagnosis. Sophonix, which has R&D facilities in Beijing and California, has built a product portfolio of instruments and reagents with independent intellectual property rights. The B round included investments from Delian Capital, Anlong Capital, GoldTech Capital, Mingshi Investment and ETP.

COVID-19 Pandemic

Another China-discovered COVID-19 vaccine has started Phase II trials. The latest candidate, based on an inactivated virus, was discovered by Beijing's Institute of Medical Biology at Chinese Academy of Medical Sciences (IMBCAMS) (see story). In May, the institute started a China Phase I trial that plans to enroll 942 healthy volunteers to assess efficacy and safety. So far, the ongoing trial has administered the candidate to 200 individuals. IMBCAMS is affiliated with Peking Union Medical College.

The Taiwan Food and Drug Administration (TFDA) granted conditional approval for the use of remdesivir in patients with severe COVID-19 disease (see story). The maker of the drug, Gilead Sciences, will be required to implement a risk management plan that ensures the drug's safety as it is used. Last month, scientists reported remdesivir shortened the treatment times and reduced the chance of death in patients whose COVID-19 infections had reached the lower respiratory tract.

Trials and Approvals

Shanghai Henlius Biotech (HK: 2696) has been approved to launch its denosumab biosimilar (HLX14) in China as a treatment for postmenopausal osteoporosis (see story). Henlius, a subsidiary of Fosun Pharma (SHA: 600196; HK: 2196), is in charge of Fosun's biologic drug operations, including both novel drugs and biosimilars. The company staged a $410 million IPO on the Hong Kong Exchange last year and it scored its first China approval in 2019 for its first biosimilar, a Rituxan® (rituximab) equivalent.

Merck/MSD (NYSE: MRK) reported China approval of Keytruda, its anti-PD-1 drug, as a second-line treatment for esophageal squamous cell carcinoma (ESCC) (see story). The ESCC must be in patients with locally advanced or metastatic forms of the disease whose tumors express PD-L1. Merck noted that Keytruda is now approved in China for five indications in three different types of cancer, including first-line use in advanced non-small cell lung cancer and second-line treatment for advanced melanoma.

InxMed (Shanghai), a clinical stage biotech. reported early research data showing its focal adhesion kinase (FAK) small molecule inhibitor was effective in overcoming drug resistance (see story). InxMed's IN10018, a FAK inhibitor, was administered together with a KRAS G12C inhibitor. Although KRAS G12C inhibitors show promise, they are subject to resistance, the company said. InxMed believes IN10018 has the potential to boost the KRAS inhibitor's effect and make other oncology therapies more effective as well.

Company News

WuXi NextCODE will restructure its genomics services operations by separating from its Shanghai office (see story). The new company, known as Genuity Science, will consist of NextCODE's Boston office as headquarters, plus existing operations in Dublin and Reykjavik. The company cited China's Human Genetic Resource Regulation (HGRAC), which prohibits ex-China use of China genomic data, as the reason for the restructuring. The new rules limiting the use of genomics data were announced in mid-2019.

AnchorDx, a Guangzhou diagnostics company, announced progress on its next-gen blood-based DNA cancer test that will screen for six types of cancer at a cost as low as $100 (see story). The test, named Aurora, uses the company's ctDNA methylation detection technology to test for lung, breast and digestive system cancers (colorectum, stomach, esophagus and liver), which together account for 65% of new cancer cases in China. AnchorDx said the one-tube DNA test offers high sensitivity and specificity, short turn-around time and low cost.

Disclosure: none.

Deals and Financings

• EverInsight Therapeutics of China acquired China/Southeast Asia rights to a novel anxiety treatment from California's VistaGen in a $177 million deal;
• Beijing's SinocellTech completed a $181 million IPO on Shanghai's STAR Board and nearly tripled in price during its initial trading session;
• Hangzhou Betta Pharma signed a $135 million agreement to in-license China rights for two immunotherapies from Agenus of Massachusetts;
• Hutchison China MediTech (Chi-Med) announced a $100 million private placement with General Atlantic to develop its novel seven-candidate portfolio;
• Shanghai's Genor Biopharma signed a $46 million deal for Asia rights to a CDK4/6 inhibitor designed to work with other IO therapies from G1 Therapeutics;
• Simcha, a novel biotech developing immunotherapies based on improved cytokines, raised $25 million in a Series A financing from two China investors;
• Sophonix of Boston closed a $14 million Series B financing led by Zero2IPO to develop point-of-care-tests for pathological and immuno-diagnosis;

COVID-19 Pandemic