Deals and Financings

Shanghai Fosun Pharma (HK: 2196; SHA: 600196) announced it has licensed US rights to a PD-1 candidate from its longstanding partner, Henlius Biotech (HK: 2696), in an $840 million agreement (see story). Although Fosun is Henlius’s controlling shareholder, Henlius declared it was looking for a US partner as recently as three months ago. Despite their relationship, Henlius negotiated an enviable contract with Fosun, consisting of a $140 million upfront payment, a one-time $50 million regulatory milestone payment and up to $650 million in sales milestones, plus royalties. The PD-1, serplulimab, was the thirteenth PD-1/L1 inhibitor approved in China. 

Tenacia Biotechnology (Shanghai) in-licensed greater China rights to a seizure therapy from Philadelphia’s Marinus Pharma in a $266 million agreement (see story). Marinus’s Ztalmy® (ganaxolone) oral suspension CV is approved in the US to treat CDKL5 deficiency seizure disorder in patients at least two years old. Tenacia, a CNS company, will make a $10 million upfront payment and pay up to $256 million in milestones, plus royalties. It will have rights to oral and intravenous dose formulations and a right of first negotiation for a future next-gen formulation or prodrug. 

Shanghai Evive Biotechnology (SHZ: 002019) out-licensed US rights for its neutropenia therapy in patients undergoing chemotherapy, particularly breast cancer (see story). The rights were acquired by Acrotech Biotech of India in a deal worth up to $236.5 million. Evive is a subsidiary of Yifan Pharma. The company developed efbemalenograstim alfa, a recombinant human Granulocyte Colony Stimulating Factor (rhG-CSF) protein, using its DikineTM technology platform. Evive was previously known as Generon. 

Jiangsu Hansoh Pharma (HK: 3692) acquired greater China rights to an EGFR/MET bispecific antibody from Zhuhai’s Biotheus in an $207 million agreement (see story). Hansoh will be responsible for all costs necessary to develop PM1080 for cancer. It will pay $7 million upfront, up to $200 million in milestones and royalties on sales. Biotheus will retain ex-China rights to the drug, which has best-in-class potential and has shown good safety/efficacy profiles in previous pre-clinical tests. PM1080 is currently in GLP toxicity studies at Biotheus. 

Nanjing Simcere Pharma (HK: 2096) acquired greater China rights to a novel insomnia therapy from Idorsia (SIX: IDIA) in a $50 million agreement (see story). Idorsia is a Swiss pharma that develops small molecule therapies. Daridorexant is a dual orexin receptor antagonist that blocks the binding of orexins, which are wake-promoting neuropeptides, without inhibiting brain activity. Idorsia says the therapy provides sleep without causing daytime sleepiness. Simcere will make a $30 million upfront payment, a $20 million payment upon China approval, plus sales milestones and royalties. 

Guangzhou Lupeng Pharmaceutical completed its second $35 million pre-B tranche led by Kaitai Capital and Temasek (see story). Temasek also led the previous $35 million pre-B tranche, which was completed one year ago. Founded in 2018, Lupeng aims to develop global best-in-class small molecule therapies for cancer, hepatitis B and autoimmune diseases. Currently, the company is conducting nine clinical trials of four clinical stage assets in China and the US. Its lead drug is a selective Bcl-2 inhibitor aimed at advanced leukemia while a second drug, a dual Bcl-2/Bcl-xl inhibitor, also targets cancer. 

SynRx Therapeutics, a Hangzhou biopharma startup, closed a $14 million Series Pre-A financing round to advance its portfolio of five oncology candidates (see story). The company focuses on solid tumor cancers with homologous recombination deficiency (HRD) – tumors that are unable to repair double-strand breaks (DSBs) in DNA, a condition that ultimately causes cancer. The company’s technology is based on original research from the lab of Founder and Chairman Xiaochun Yu. The round’s investors include Lapam Capital, Fenghua Venture, Westlake Innovation Capital and Long Yield Venture Capital. 

Company News

WuXi Vaccines, a division of WuXi Biologics, will acquire an 8,500-square-meter facility Suzhou manufacturing facility from Harbour BioMed (HK: 2269) (see story). The plant, WuXi Vaccines' first standalone vaccine development and GMP manufacturing site in China, will be renovated to provide vaccine development and GMP manufacturing services. The terms of the agreement were not disclosed. WuXi Vaccines has also built a $240 million manufacturing facility that is near completion in Dundalk, Ireland. 

Trials and Approvals

Shanghai Everest Medicines (HK: 1952) reported its NDA for Nefecon, a treatment for IgA nephropathy (IgAN), was accepted for review in China (see story). The condition is a chronic autoimmune disease associated with progressive renal impairment. Nefecon is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity. It is designed to remain intact until it reaches the Peyer's patch region of the lower small intestine. In 2019, Everest acquired Greater China rights to Nefecon from Sweden’s Calliditas in a $121 million pact. 

Shanghai Nuance Pharma was approved to start a pivotal China Phase III clinical trial of MVA-BN RSV vaccine to prevent respiratory syncytial virus (RSV) in adults (see story). In 2021, Nuance in-licensed China and Southeast Asia rights to the vaccine from Copenhagen’s Bavarian Nordic in a $225 million deal. The vaccine is aimed at older and/or immunocompromised adults. The China trial will be run as an arm of a large Bavarian Nordic Phase III trial that will enroll more than 20,000 patients in the US and Germany. 

Disclosure: none.