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Deals and Financings

Jiangsu Hengrui Pharma out-licensed US rights for a novel small molecule EZH2 inhibitor in a $706 million agreement with Treeline Biosciences of Connecticut (see story). Treeline is an 18-month-old small molecule pharma that has raised $473 million for novel drug development.

Hengrui has filed a China IND for SHR2554 in patients with peripheral T-cell lymphoma (PTCL), though the company also says it will publish results from a pre-Phase I clinical trial in the Lancet. Hengrui will receive an upfront payment of $11 million and milestone payments of up to $695 million, plus royalties. 

A CSPC Pharma (CHJTF) subsidiary out-licensed ex-China rights for a Nectin-4 antibody drug conjugate to Boston’s Corbus Pharma (CRBP) in a heavily backloaded $692.5 million deal (see story). Corbus will have rights to SYS6002 in the US, EU, and Australian markets.

CSPC Megalith Biopharma has started a China Phase I dose-escalating trial of the candidate in patients with advanced solid tumor cancers. CSPC will receive a $7.5 million upfront payment and up to $685 million in milestones, plus royalties on sales. CSPC plans to aim SYS6002 at urothelial cancer initially. 

Harbour BioMed out-licensed US rights for a bispecific immune activator to Cullinan Oncology (CGEM) of Alabama in a $588 million deal (see story). Harbour created HBM7008, a B7H4 x 4-1BB bispecific, using its next-gen heavy chain only multi-specific antibody discovery platform, HBICE. The company will receive $25 million upfront, $148 million in development/regulatory milestones, up to $415 million in sales milestones, plus tiered royalties.

Harbour is conducting US and Australian Phase I trials of HBM7008 in patients with advanced solid tumors. Harbour has development labs in China, Boston headquarters, and drug discovery operations in Rotterdam. 

Wondercel Therapeutics, a Shenzhen next-gen immune cell therapy company, raised $14 million in an angel round from Yuansheng Venture, the only investor in the funding (see story). Wondercel is led by the former CSO and Co-Founder of Nanjing’s Legend Biotech, Xiaohu Fan.

Legend made its name by developing the first CAR-T therapy in China, Carvykti, an autologous BCMA targeting CAR-T approved in China, the US, and the EU for multiple myeloma. Dr. Fan has said the new company will develop safer and less-expensive immune cell therapies for oncology, organ transplantation, and autoimmune diseases. 

Trials and Approvals

Clover Biopharma launched its COVID-19 vaccine, a recombinant SARS-CoV-2 subunit vaccine, in China as a second booster dose (fourth vaccination dose) for older adults, immuno-compromised individuals, and individuals with comorbidities (see story). The launch will start in Zhejiang province and move to additional areas in Q1 2023.

In a global trial that enrolled over 30,000 participants, Clover’s vaccine showed a fivefold increase in neutralizing antibodies against the BA.5 Omicron variant compared to a third dose of an inactivated vaccine. The vaccine was approved on an emergency use basis in China two months ago. 

Shanghai Henlius Biotech reported the US FDA has accepted its BLA for trastuzumab, a biosimilar to Roche’s Herceptin (see story). Henlius, together with its US affiliate, Accord, is seeking approval of the biosimilar in three HER2-overexpressing conditions: breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma.

To acquire the rights in 2020, Accord paid $27 million upfront, up to $13 million in regulatory milestones, sales milestones, and a tiered double-digit royalty of up to 50% of future net profits. 

Shanghai Junshi Bio (SHJBF) and Coherus (CHRS) of Redwood City, CA reported their partnered PD-1 posted positive results in a US Phase III nasopharyngeal carcinoma trial (see story). Toripalimab produced a statistically significant improvement in overall survival, though details were not released.

It was administered as a first-line therapy in combination with gemcitabine and cisplatin for recurrent or metastatic NPC. Two years ago, Coherus, a US company set up to in-license China drugs, paid $150 million upfront to acquire US-Canada rights to the PD-1 in a deal worth up to $1.1 billion. 

Boan Biotech, a Luye Pharma subsidiary that develops novel antibodies, dosed the first patient in a China Phase I trial of its anti-CD25 antibody in patients with solid tumor cancers (see story). BA1106 is an investigational non-IL-2 blocking anti-CD25 antibody that Boan believes has promising anticancer potential to treat cancers with high expression of CD25, a broad spectrum of possible indications.

BA1106 is the first investigational anti-CD25 antibody to start clinical trials in China. Boan says it has been speeding up its novel antibody development, focusing on oncology and autoimmune diseases. 

Frontera Therapeutics, a US-China gene therapy company, has begun China trials of its three leading candidates – all starting in the first two months of 2023 (see story). The company’s APEX Technology & Manufacturing Platform is an adeno-associated virus (AAV) gene expression system based on novel and clinically validated AAV vectors.

The trials include FT-002 for X-linked retinitis pigmentosa (XLRP); FT-003 for neovascular or wet age-related macular degeneration (wAMD); and FT-001 for Leber Congenital Amaurosis-2, an inherited retinal disease. Frontera is headquartered in the Boston area with labs and a manufacturing facility in Suzhou. 

Suzhou Innovent Bio (IVBXF) has dosed the first patient in a China Phase III trial of picankibart, a novel mAb, as an extended-dose therapy for psoriasis (see story). Picankibart (IBI112) specifically binds to IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors and inhibiting the IL-23 receptor-mediated signaling pathway.

Participants in the trial will be treated with an injected dose of picankibart every 12 weeks over a 68-week schedule. The candidate was developed in-house by Innovent, known mainly for its oncology portfolio, though the company is also active in metabolic, autoimmune, ophthalmology, and other diseases. 

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