Deals and Financings

South Korea’s AriBio out-licensed China rights for AR1001, an Alzheimer’s disease candidate, in an agreement worth up to $770 million ($90 million upfront) (see story). The company acquiring the asset asked to remain anonymous because of the competition for Alzheimer’s drugs in China. AR1001 is an oral PDE5 inhibitor and originally a South Korean candidate for erectile dysfunction. In pre-clinical studies, AR1001 inhibited neuron apoptosis and restored synaptic plasticity, according to the company, and it has also shown the ability to reduce hyperphosphorylated tau proteins in a Phase II trial. 

AnHeart Therapeutics, a New York-Hangzhou biopharma, will become part of Nuvation Bio (NYSE: NUVB) of New York in an all-stock deal (see story). Shareholders of AnHeart will own 33% of Nuvation after the close, implying a value of $253 million at Nuvation’s current valuation. Nuvation has $600 million in cash, which may be part of AnHeart’s interest in the company. AnHeart’s lead candidate is a selective next-gen ROS1/NTRK inhibitor, taletrectinib, that is being tested in NSCLC patients. AnHeart has sold China rights for the drug to Innovent and Japan and Korea rights to other companies. 

San Diego’s Avenzo Therapeutics closed a $150 million Series A-1 round to develop its lead program AVZ-021, a potentially best-in-class CDK2 selective inhibitor, currently in a Phase I/II trial in patients with HR+/HER2- metastatic breast cancer and other advanced solid tumors (see story). In January 2024, Avenzo acquired rights to the drug from Allorion Therapeutics, a Boston-Guangzhou biotech, in a deal worth over $1 billion ($40 million upfront). Allorion kept China rights to the drug. Allorion develops mutant selective and isoform-specific drugs in non-conventional ways for well-known targets to improve efficacy and prevent resistance. 

Biocytogen Pharma (Beijing) will collaborate with ABL Bio of Korea to develop new bispecific antibody-drug conjugates (see story). ABL says it is the first Korean pharma to have started clinical trials of its own bispecific.  Biocytogen will use its RenLite® mice platform to produce fully human antibody candidates with diverse epitopes and high affinity. The company has signed 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and established 42 target-nominated RenMice® licensing projects globally. 

Company News

WuXi AppTec, the China based CRDMO, continues to face charges that it steals information from its biopharma clients, sharing it with China’s government (see story). According to a Reuters report, US intelligence officials told members of the US Senate in late February that WuXi has illegally transferred intellectual property from US clients to China authorities. The senators are writing a proposed law that sanctions WuXi and could close the company’s US operations. WuXi AppTec denied the charges, saying that protecting client’s data is “of utmost importance” to it, that it has never been accused of misusing information, and that it complies with all US laws. Currently, WuXi derives 65% of its revenues from US companies. 

Trials and Approvals

Sperogenix Therapeutics of Shanghai announced its NDA for Agamree (vamorolone), a treatment for Duchenne muscular dystrophy (DMD), has been accepted for review by China’s Center for Drug Evaluation (see story). Two years ago, Sperogenix in-licensed greater China rights to the drug from Santhera Therapeutics of Switzerland in a $124 million agreement. A novel drug, Agamree binds to the same receptor as glucocorticoids but modifies its downstream activity for better safety. Sperogenix is a China rare disease company. 

Guangzhou Bio-Thera was cleared to start a US Phase II trial for BAT8006, an ADC targeting Folate Receptor α (FRα) (see story). The study will enroll patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. BAT8006 was developed using Bio-Thera's proprietary anti-FRα antibody and proprietary ADC linker-payload combination inhibitor. In preclinical studies, the candidate showed potential for good stability and safety along with strong anti-tumor activity. The company said BAT8006 showed a strong bystander effect in a Phase I trial. Bio-Thera is developing a portfolio of 24 novel and biosimilar candidates. 

Beijing InnoCare Pharma has dosed the first patient in a China Phase Ib trial of ICP-189, its SHP2 allosteric inhibitor, in combination with ArriVent’s furmonertinib to treat advanced or metastatic non-small cell lung cancer (NSCLC) (see story). Furmonertinib is an approved highly brain-penetrant EGFR inhibitor. ICP-189 is a novel selective oral allosteric inhibitor of SHP2 (Src homology 2 domain containing protein tyrosine phosphatase), a non-receptor protein tyrosine phosphatase that is usually expressed in the cytoplasm of several tissues. Innocare’s ICP-189 has shown preliminary efficacy as a monotherapy. 

Shanghai GenFleet announced a clinical trial collaboration to test a combination of GFH009 (a CDK9 inhibitor) and BioGene’s Brukinsa® (a BTK inhibitor) in patients with diffuse large B cell lymphoma (see story). GenFleet will conduct an open-label, single-arm and multi-center (10 hospitals in China) study of the combination to evaluate its safety and efficacy. BeiGene will provide clinical drug supplies of Brukinsa®(zanubrutinib) for the Phase Ib/II trial. The first patient has been dosed in the trial, which is led by Henan Cancer Hospital and Fudan University Shanghai Cancer Center.