Deals and Financings

Cullgen, a San Diego-Shanghai company, will collaborate with Japan's Astellas Pharma (TSE: 4503) to discover multiple innovative protein degraders in a deal worth up to $1.9 billion (see story). Cullgen will apply its proprietary uSMITE™ targeted protein degradation platform featuring novel E3 ligands with Astellas' drug discovery capabilities. Protein degraders break down proteins rather than blocking them. Initially, the two companies will focus on a cell cycle protein degrader aimed at breast cancer and other solid tumors. Cullgen will receive $35 million upfront and another $85 million if Astellas exercises an option on the lead candidate. 

Cholesgen (Shanghai) formed a three-year collaboration with AstraZeneca (NYSE: AZN) to develop new candidates for hypercholesterolemia and related metabolic diseases (see story). The joint research effort will focus on selected targets from Cholesgen's early-stage portfolios. Cholesgen will be entitled to receive an initial payment, as well as a license package for each drug candidate that AstraZeneca chooses to advance into clinical development. One week ago, the AstraZeneca CICC Medical Industry Fund, a $1 billion effort to support China-based drug startups, participated in Cholesgen’s $14 million initial round. 

Simcere Pharma (HK: 2096) signed a Sponsored Research Agreement with Mass General Brigham of Boston to discover new treatments for patients with cancer, autoimmune and CNS disease (see story). Under the agreement, Simcere will fund up to eight research groups at Mass General Brigham on selected projects over the next two years. Simcere will have access to cutting-edge research and leading clinical skills, which will accelerate its global R&D efforts. In addition, Simcere’s Project X, which provides talented scientists with funding and employment, will further contribute to Boston’s local medical research community. 

Trials and Approvals

China Medical System Holdings (HK: 0867) was approved to launch its novel Diazepam Nasal Spray in China to treat seizure clusters in epilepsy patients who are at least 6 years old (see story). Although diazepam is commonly prescribed for epilepsy globally, there are no China-approved diazepam products for the condition. CMS’s novel nasal delivery system allows easy administration with a fast onset of just four minutes to stop seizures. In a US trial, 87% of seizure cluster episodes required only a single dose of the product over a 24-hour period. 

Suzhou Innovent Biologics (HK: 01801) presented data showing its anti-CD47/PD-L1 bispecific antibody was effective in a China Phase I trial that enrolled Hodgkin lymphoma patients who were resistant to PD-(L)1 therapies (see story). The company said IBI322 was the first anti-PD-L1 bispecific to start clinical trials anywhere in the world. Among the 23 evaluable patients, the objective response rate was 48% and the disease control rate 91%. Innovent termed the results “promising” with a manageable safety profile for Hodgkin patients who are refractory to anti-PD-1/PD-L1 therapies.

Jiangsu Ractigen Therapeutics, a novel oligonucleotide biopharma, dosed the first patient in the first-in-human trial of rag-17, an siRNA candidate, that enrolled ALS patients with sod1 mutation (see story). Rag-17 is a siRNA candidate designed to provide potent and durable knockdown of the sod1 protein in the central nervous system to prevent degradation of motor neurons and delay disease progression. Although delivery to tissue has been historically difficult for siRNA candidates, Rag-17 uses a novel smart chemistry-aided delivery (scad) conjugate that facilitates broad biodistribution and tissue uptake throughout the CNS. 

HighField Bio, a Hangzhou company that develops immunoliposomes for cancers, was approved to start a US trial of HF158K1, its drug encapsulated immunoliposome containing doxorubicin to treat refractory solid tumor cancers (see story). The company believes the immunoliposome technology offers the ability to deliver larger doses of active drug and targets tumor cells using multiple antibodies compared to ADC drugs. This allows the drug to use an API that is less toxic than an ADC candidate, but may also increase efficacy because the molecule has larger drug-to-antibody ratios that create wider therapeutic windows, targeting more cancer cells with fewer dose-limiting toxicities. 

Shanghai MindRank, an AI-based drug discovery company, dosed the first healthy volunteer in a Phase I study of its lead candidate aimed at treating obesity and type 2 diabetes mellitus (see story). MDR-001, an oral β-arrestin 2 small-molecule glucagon-like peptide 1 receptor agonist, was discovered using MindRank's proprietary AI platform, Molecule Pro. The platform advanced MDR-001 to IND approval in only 19 months. The company said it had to synthesize and test fewer than 100 chemical compounds before finding the preclinical candidate, which it believes has best-in-class potential. 

Genor Biopharma (HK: 6998), a Beijing company, reported that its PD-1 monoclonal antibody, GB226, was rejected by China NMPA as a therapy for a rare form of lymphoma (see story). GB226, which was in-licensed from CBT Therapeutics, a CrownBio subsidiary, was seeking approval to treat relapsed or refractory peripheral T-cell lymphoma. One week ago, Genor published data from a GB226 trial that showed the drug produced an overall response rate of 68%, though the trial enrolled only 25 patients over three years, presumably because of its rarity. Genor’s offering is the first drug in its class to be rejected. 

Disclosure: none.