Deals and Financings

Shanghai Junshi Bio (HK: 1877; SHA: 688180) out-licensed US-Canada rights for its anti-PD-1 antibody to Coherus Bio in an agreement worth up to $1.1 billion (see story). Coherus will pay $150 million upfront. Coherus also received options for an anti-TIGIT antibody and a next-gen engineered IL-2 cytokine, as well as first negotiation rights for two early-stage checkpoint inhibitor antibodies. Junshi's Tuoyi (toripalimab) is the first China-developed anti-PD-1 antibody approved in China.  

Beijing InnoCare (HK: 09969) announced it raised $407 million in private placements with two Hillhouse Capital subsidiaries and Vivo Opportunity Fund (see story). The new shares represent 14% of InnoCare's outstanding shares post-investment, valuing the company at $2.9 billion. The Hillhouse affiliates bought 90% of the new shares. InnoCure is developing 10 candidates aimed at malignant tumors and autoimmune diseases with trials under way in China and the US.

Syapse, a San Francisco company that collects clinical cancer data, closed a $68 million growth equity investment led by China's Ally Bridge Group (see story). Syapse describes itself as a real-world evidence company that aims to improve the delivery of precision medicine. Its Syapse Learning Health Network^TM partners with community health systems to identify precision medicine strategies that improve clinical outcomes. The financing included Northpond Ventures and existing investors.

Nantong Lianya Pharma, a division of Novast, completed a $62 million funding that was led by Highlight Capital, with participation from Shiyu Investment (see story). The company has 40 US-approved difficult-to-make generic drugs including over 30 hormone products and nine oral controlled-release drugs. Lianya is applying for China approvals of the drugs. One year ago, it raised $140 million in private equity led by Legend Capital. Founded in 2005, Lianya focuses on drug delivery/extended release formulations of generics.

Shanghai Junshi Bio (HK: 1877; SH: 688180) will make a $50 million strategic investment in Coherus BioSciences (NSDQ: CHRS), a San Francisco area biosimilar commercialization company (see story). Yesterday, Coherus announced it would acquire US-China rights to Junshi's anti-PD-1 antibody (and several other candidates) in a deal worth up to $1.1 billion, including a $150 million upfront payment to Junshi. At the time, nothing was said about the $50 million Junshi investment in Coherus. Junshi's Tuoyi (toripalimab) is the first China-developed anti-PD-1 antibody approved in China.  

Beijing neoX Biotech completed a $30 million Series A Financing for its AI drug discovery platform (see story). The company combines AI and biophysics to discover and develop macromolecular drugs and multi-specific drugs, especially immunoncology therapies, with a particular interest in protein-protein interactions. The A round was co-led by Sky9 Capital and 5Y Capital. Bertelsmann Asia, Vertex Ventures and existing investors Vision Plus Capital and Sequoia Capital China also participated.

Suzhou's Adagene (NSDQ: EXEL) will license its SAFEbody™ technology platform, which generates masked versions of monoclonal antibodies, to Exelixis for use in Exelixis’ ADC preclinical pipeline (see story). Exelixis will make an upfront payment of $11 million to Adagene and will have the ability to nominate two targets during the collaboration. Adagene will be eligible for development and commercialization milestones, as well as royalties on net sales of any developed products. Exelixis is headquartered in Alameda, CA. http://www.chinabiotoday.com/articles/adagene-mab-masking-exelixis

Sequoia Capital China and Illumina (NSDQ: ILMN) will partner to launch a genomic incubator in China to nuture genomic startups that have potential to develop breakthrough technologies (see story). The incubator will join two similar Illumina entities, one in San Francisco and the other in Cambridge, UK. The Shanghai lab will offer two six-month funding cycles per year. During incubation, companies will have access to investment and business guidance from Sequoia, plus access to Illumina sequencing systems, reagents and genomics expertise, The first cycle will begin in Fall 2021.

COVID-19 Pandemic

Tianjin CanSino Biologics (HK: 6185; SHA: 688185) reported its AD5-nCOV vaccine met interim primary safety and efficacy endpoints without any serious adverse events (see story).  CanSino said it expects to see unblinded interim results from the trial later this week. The Phase III clinical trial of Ad5-nCoV enrolled 40,000 volunteers of all ages in 78 clinical trial sites located in five countries. CanSino's candidate is delivered by an adeno-associated virus serotype 5 (AAV5) vector and was China's first COVID-19 vaccine to begin clinical trials.

Chengdu's Clover Biopharma announced plans to start a global Phase II/III efficacy trial of its S-Trimer COVID-19 vaccine together with a Dynavax (NSDQ: DVAX) adjuvant (see story). Previously, Clover was using a GSK adjuvant, but decided to switch based on "manufacturing considerations" for the GSK product. Also today, Clover published positive early results of the Clover-GSK combination in The Lancet. Clover's vaccine can be manufactured to produce hundreds of millions of doses and stored in a regular refrigerator, making it valuable for low-resource settings.

Trials and Approvals 

Suzhou Innovent Biologics (HK: 01801) and its partner Eli Lilly (NYSE: LLY) announced China approved its supplemental NDA of their partnered anti-PD-1 drug, Tyvyt® (sintilimab injection), as a first-line treatment for nonsquamous non-small cell lung cancer (see story). Tyvyt will be administered in combination with pemetrexed and platinum chemotherapy. In 2018, Tyvyt was first approved in China as a third-line treatment for Hodgkin's lymphoma. Innovent is conducting over 20 Tyvyt clinical studies, including more than 10 registrational or pivotal clinical trials.  

Beijing InnoCare (HK: 09969) was approved to start a China Phase III trial of its Bruton’s tyrosine kinase (BTK) inhibitor in combination with R-CHOP as a first-line treatment for mantle cell lymphoma (MCL) (see story). In late 2020, orelabrutinib was approved by China's NMPA to treat relapsed/refractory MCL along with r/r chronic lymphocytic leukemia (and small lymphocytic lymphoma. In the US, orelabrutinib has Orphan Drug Designation for MCL. InnoCare expects it will be effective in several B-cell malignant lymphomas.  

Shanghai I-Mab (NSDQ: IMAB) started China and US trials of its CD73 antibody, uliledlimab, in combination with PD-(L)1 inhibitors (see story). CD73 is thought to suppress immune responses in tumors. Uliledlimab works by inhibiting the adenosine pathway to inhibit CD73, which I-Mab expects will enhance the immune response of PD-(L)1 inhibitors. Overall, I-Mab is currently conducting three Phase I clinical trials in the US and China, plus another four China trials, mostly Phase II or III.  

Kira Pharma, a global biotech developing complement-targeted therapies for immune-mediated diseases, dosed the first healthy volunteer in a Phase I trial of P014, its lead candidate (see story). P014 is a novel bi-functional biologic that is designed to block two separate rate-limiting steps in the complement activation cascade. The company plans to test P014 in several complement-mediated diseases. In late 2020, Kira closed a $53 million Series B+ financing. The company is headquartered in Cambridge, MA with R&D operations in Suzhou.  

Chengdu Kanghong Pharma (SHZ: 002773) announced conbercept was granted Special Protocol Assessments in the US for three new retinal indications (see story). Conbercept is an anti-VEGF fusion protein, approved and marketed in China as Lumitin^® to treat retinal diseases. The additional indications are DME (Diabetic Macular Edema) and RVO (Central Retinal Vein Occlusion and Branch Retinal Vein Occlusion), which can cause blurred vision and sudden vision loss. The SPA may also lead to a wider treatment range for conbercept in age-related macular degeneration and blindness.

Disclosure: none.