Week In Review: Under Pressure From US Congress, WuXi AppTec Resigns From BIO

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Company News

BIO, the global lobbying organization for biotechnology firms, forced WuXi AppTec (WUXIF) to leave the group due to pressure from the US Congress (see story). The Committee on the Chinese Communist Party, a US Congressional committee, objected to BIO’s attempt to stop the BIOSECURE Act, which was written to prevent any taxpayer money from being spent on WuXi AppTec’s CRDMO businesses.

The Congressional committee is also worried that WuXi, which has several facilities in the US, would use genetic data gathered from clinical trials to harm US citizens. WuXi sent a letter to BIO, saying it will resign from the organization. 

Deals and Financings

Meanwhile, Germany’s Boehringer Ingelheim acquired an option to license drug candidates that treat symptoms of schizophrenia from Sosei Heptares (SOLTF) of Japan in an agreement worth up to $822 million (see story). Sosei Heptares is currently conducting a Phase I trial of a first-in-class GPR52 agonist for the indication.

Boehringer Ingelheim will have an option to acquire the agonists after Sosei completes Phase Ib trials. Sosei expects the chosen candidate will be effective against all symptoms of the disease, which are separated into positive (psychosis, delusions, and hallucinations), negative (withdrawal and apathy), and cognitive (attention, planning, and memory deficits) conditions. 

Jiangsu Hansoh Pharma (HNSPF) extended its partnership with Zhuhai Biotheus, acquiring global rights to Zuhai’s proprietary anti-EGFR/cMet bispecific antibody in a $700 million agreement (see story). Two years ago, Hansoh acquired China rights to the candidate for $207 million. Now, the company will be in charge of taking the bispecific to global markets, although it does also have rights to sublicense it.

Zhuhai’s candidate is a 1+1 heterodimeric EGFR/cMet bispecific antibody, designed to inhibit the growth and survival of tumors. It is currently in Phase I clinical trials to treat solid tumors including non-small-cell lung cancer. 

PegBio, a Suzhou biotech, filed for a Hong Kong IPO to support commercialization of its long-acting pegylated GLP-1 receptor agonist for type 2 diabetes and obesity (see story). The company says its pegylated technology will require only a once-weekly administration for PB-119.

PegBio has filed for NMDA approval of the drug, which has completed two China Phase III trials in T2DM patients, one as a monotherapy and the other in combination with metformin. The company expects a ruling in late 2024, allowing for a launch in early 2025. It has five additional novel products in development. 

Trials and Approvals

Yantai RemeGen (REGMF) said an interim analysis of its anti-HER2 antibody drug conjugate (ADC) showed efficacy in the cervical cancer cohort of a China Phase II trial (see story). The Phase II open-label trial is currently testing Disitamab Vedotin (RC48) as a monotherapy in patients with HER2-expressing gynecologic malignancies.

In June 2021, RC48 was granted conditional approval in China for locally advanced or metastatic gastric cancer. Three years ago, RemeGen out-licensed ex-China rights for RC48 to Seattle’s Seagen in a $2.6 billion ($200 million upfront) agreement. 

Ranok Therapeutics, a Hangzhou-Boston biopharma that targets protein degradation for the treatment of cancers, started a China Phase I study of RNK05047, its lead protein degrader candidate (see story). RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader discovered by Ranok.

The company already has a US-based Phase I trial of the candidate underway. The China trial will enroll Chinese patients with advanced solid tumors or lymphomas. Ranok expects to report preliminary data from the two Phase 1 studies by the end of 2024. 

Singapore’s Aslan Pharma (ASLN) reported new positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of chronic obstructive pulmonary disease (COPD) (see story).

Eblasakimab is a mAb that targets the IL-13 receptor subunit of the Type 2 receptor, a pathway that drives several allergic inflammatory diseases. Aslan believes the candidate has the potential to outperform current biologics that are used to treat allergic diseases. 

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