Week in Review:

Company News

Shanghai WuXi Biologics (HK: 2269) has broken ground on a $1.4 billion facility in Singapore, the first CRDMO to offer end-to-end biologics research, development and manufacturing in the city-state (see story). Last year, the company said its new bioprocessing platform, WuXiUI™, offers a 3 to 6-fold increase in productivity and a 60-80% savings in cost of goods sold compared to other fed-batch processes in single-use bioreactors. The Singapore facility, which will add 120,000L of manufacturing capacity to the company’s global network, is expected to employ 1,500 staff when it reaches full capacity. 

WuXi AppTec (SHA: 603259/HK: 2359) the China-based CRDMO, reported 2023 results showing a modest gain in revenue (2.5%) to over 40 billion RMB ($5.6 billion) for the year earlier, an increase that is significantly higher if the 2022 COVID revenues are subtracted – then the increase climbs to 25.6% (see story). WuXi now provides services to 6000 companies. But there is a very sour note to this success: 65% of WuXi’s business is with US-based companies, which means that pending legislation in Congress, aimed at shutting down WuXi’s US business, could reduce WuXi’s income by $3.6 billion. 

Novo Nordisk, the Danish biopharma centered on diabetes therapies, announced plans to invest $556 million to expand its Tianjin city production facility, presumably to manufacture its blockbuster weight loss drug, Wegovy (see story). The GLP-1 receptor agonist was initially approved to treat type2 diabetes in 2017, but its sales increased greatly since being approved as a weight loss therapy. In late 2023, Novo announced plans for a $6 billion plant in Denmark, and one month ago, it paid $16.5 billion to acquire a large drug manufacturing company Catalent. 

Germany’s Merck, together with MilliporeSigma, its US-Canada life science division, announced plans to invest $326 million in a new Bioprocessing Production Center in Daejeon, South Korea (see story). The company said the new facility will be its largest investment in Asia-Pacific life science infrastructure so far. The new facility will offer a full range of services for biologic drugs, including process development, clinical research and commercial manufacturing, for in-demand biologic products. Merck, which expects to hire about 300 employees to staff the facility, said the new facility reflects Asia-Pacific’s growing importance in biologic drugs. 

Trials and Approvals

BeiGene (NSDQ: BGNE; HK: 06160; SHA: 688235) was approved to market Tevimbra® (tislelizumab-jsgr) in the US for patients with unresectable or metastatic esophageal squamous cell carcinoma (see story). Patients must have previously been treated with chemotherapy that did not include a PD-(L)1 inhibitor. The approval took a very long 20 months because US regulators were not allowed to inspect BeiGene’s manufacturing plant due to COVID restrictions. At one point, BeiGene had out-licensed Tevimbra to Novartis in a $2.2 billion deal ($650 million upfront). Novartis returned the rights to BeiGene six months ago, claiming that regulatory problems soured the deal. 

Shanghai KeChow Pharma can market tunlametinib in China to treat patients with NRAS mutated advanced melanoma who were previously treated with PD-1/PD-L1 (see story). Tunlametinib, KeChow’s lead candidate, is a small molecule inhibitor of Mitogen-activated protein kinase (MEK). KeChow believes its candidate does a better job of inhibiting targets and improving pharmacokinetics than already approved MEK inhibitors. The company, which owns global rights to tunlametinib, plans to develop the drug in China as a monotherapy and in combination with other standard of care therapies to treat additional cancers. 

Innovent Biologics (HK: 01801) reported that efdamrofusp alfa high-dose met its primary endpoint in the second Phase II trial that enrolled China patients with neovascular age-related macular degeneration (nAMD) (see story). The two Phase II studies, which compared the Innovent drug with Aflibercept, showed that IBI302 can be administered every 12 weeks. Innovent says the therapeutic properties of efdamrofusp alfa derive from its double targets: the VEGF domain that blocks angiogenesis, and the complement binding domain that inhibits an inflammatory response. 

Suzhou Alphamab Oncology (HK: 9966) reported positive data from a Phase II trial of KN046, its anti-PD-L1/CTLA-4 bispecific antibody plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) (see story). The bispecific candidate is engineered to target the tumor microenvironment with high PD-L1 expression and clearing of Treg cells. Alphamab is conducting about 20 clinical trials of KN046 for over 10 indications, including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC. The trial results were published online in Cell Reports Medicine. 

Shanghai Antengene has started the dose expansion portion of a China/Australia Phase II trial of ATG-022, a Claudin 18.2 antibody-drug conjugate (see story). The trial, which is already underway, enrolled patients who have advanced or metastatic solid tumors, some of whom have experienced partial or complete responses. The study’s primary goal is to evaluate the safety and tolerability of ATG-022 and to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of ATG-022 as a monotherapy. The US FDA has granted two Orphan Drug Designations for ATG-022, one for gastric cancer and the another for pancreatic cancer. 

Suzhou NeuExcell Therapeutics, a company focused on in vivo neural regenerative therapies, dosed the first patient with a first-in-class NeuroD1 gene therapy product NXL-004 (see story). The company explains that neural tissues contain two major types of cells: neurons and supportive glial cells such as astrocytes. Although neurons cannot divide or replenish themselves, glial cells can.  Because both are derived from neural stem cells, neurons and astrocytes have many similar traits. NeuExcell applies its astrocyte-to-neuron (AtN) conversion technology to replace dead neurons in diseased or injured tissues. The investigator trial will evaluate NXL-004 in patients with glioblastoma.