AbbVie's SHP2 partner files for Hong Kong IPO

Jacobio Pharma has filed for an IPO in Hong Kong. The Beijing-based drug developer is one of a few companies working on cancer therapies that target Src homology-2-containing protein tyrosine phosphatase 2, or SHP2, an enzyme that is important for regulating normal cell growth and survival but is compromised in some cancers. The company's pipeline caught the attention of AbbVie, which signed Jacobio to a strategic collaboration in June for exclusive rights to its SHP2 programs.

Jacobio was founded in 2015 by Yinxiang Wang, co-founder of Zhejiang's Betta Pharma, the maker of China's non-small cell lung cancer drug icotinib. With the biotech sector booming this year, Jacobio is coming to the market with its two SHP2 inhibitors, JAB-3068 and JAB-3312. Both have received orphan drug designation from the U.S. Food and Drug Administration and are in Phase 2 development.

Other SHP2 inhibitors in development include Navire Pharma's IACS-13909, Revolution Medicines/Sanofi's RMC-4630, and Novartis's TNO155.

Pfizer snaps up 9.9% of Hong Kong-listed CStone Pharma

U.S. pharma giant Pfizer is investing $200 million in CStone Pharma, picking up a 9.9% equity stake in the Suzhou-based company in what could be seen as further validation for the innovation coming from Chinese drug developers.

The strategic collaboration allows the two drug makers to jointly develop and commercialize for the Chinese market CStone's anti-PD-L1 monoclonal antibody, sugemalimab, in addition to other cancer drugs in Pfizer's pipeline. As part of the deal, Pfizer will pay up to $280 million in milestone payments plus royalties from sales for CStone's novel antibody.

In August, the therapy beat its Phase 3 clinical trial primary endpoint as a first-line treatment for late-stage squamous and non-squamous non-small cell lung cancer. When combined with chemotherapy, sugemalimab showed it can cut the risk of disease progression or death by half.

There's been no shortage of cross-border partnerships in recent years, but this deal grants Pfizer commercialization rights of sugemalimab in China instead of in the U.S. and other markets. CStone keeps global commercialization rights to the drug outside of China.

"Our company has an extensive and proud history of bringing innovative medicines to patients in China," Pfizer China's acting president Pierre Gaudreault said in a statement.

Junshi's PD-1 drug clears Phase 3 for throat cancer

Junshi BioSciences' claim-to-fame cancer drug, toripalimab, chalked up another win last week after an independent data monitoring committee determined that the anti-PD-1 antibody met its primary endpoint at the interim analysis of its global Phase 3 study, JUPITER-02, for treating nasopharyngeal carcinoma, a subtype of head and neck cancer that is more common in Southeast Asia than in other parts of the world.

The study showed that Junshi's antibody improved progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma when used in combination with chemotherapy compared to chemotherapy alone.

Toripalimab, sold as Tuoyi, has been approved for second-line treatment of metastatic melanoma in China since December 2018. The company is investigating its efficacy in more than 30 clinical studies across more than 10 cancer types worldwide.

Innovent's PD-1 clears Phase 3 for liver cancer

An anti-PD-1 therapy from Innovent Biologics, sintilimab (marketed as Tyvyt), also beat its Phase 3 trial endpoint for treating patients with advanced hepatocellular carcinoma, the Suzhou-based drug maker announced last week.

An interim analysis of the ORIENT-32 study showed that patients who received a combination of Tyvyt and Byvasda — Innovent's bevacizumab biosimilar — as first-line therapy had significantly better progression-free survival and overall survival compared to sorafenib, co-developed and co-marketed as Nexavar by Bayer and Onyx Pharmaceuticals. Innovent said the trial's data will be presented at an upcoming medical conference.

Co-developed with Eli Lilly, Tyvyt was one of the first PD-1 inhibitors to be approved in China and remains the only one reimbursable under the country's health insurance scheme. The therapy is being investigated in a number of late-stage trials for different cancer indications. Last month, Tyvyt met its primary endpoint in another Phase 3 trial showing its effectiveness in treating non-small cell lung cancer when used in combination with Lilly's chemotherapy agent Gemzar (gemcitabine).