Fierce Pharma Asia—AstraZeneca eyes China's innovation, plots Singapore ADC plant; FDA rejects Hengrui's PD-1 drug

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来源: FiercePharma

AstraZeneca made multiple headlines related to Asia this week. In addition, the FDA's rejection of Hengrui's PD-1 inhibitor made our news roundup.

AstraZeneca's CEO wants to tap into China's innovation explosion. The company inked an oncology antibody deal with Harbour BioMed, and it plans to build a $1.5 billion ADC plant in Singapore. Hengrui and Elevar's proposed PD-1/VEGFR liver cancer combination has been rejected by the FDA. Plus more.

1. AstraZeneca to harness China's explosion of innovation to boost cell therapy R&D

Innovation in China has “exploded,” and AstraZeneca plans to utilize its growing presence in the country to boost its R&D ambitions in cell therapy, CEO Pascal Soriot said during an investor event. Clinical development of cell therapy in China can “move much faster than anywhere else in the world,” he said. The British pharma has made several deals with Chinese companies over the past two years, including its $1 billion acquisition of Gracell Biotechnologies.

2. AstraZeneca pays $19M to Harbour BioMed's Nona for preclinical cancer antibodies

Speaking of tapping into China’s innovation, AstraZeneca paid Harbour BioMed’s U.S. subsidiary Nona Biosceicnes $19 million upfront for preclinical monoclonal antibodies as potential targeted cancer therapies. Nona’s mice-based technology can produce heavy chain-only antibodies. The deal also includes $10 million in near-term payments and another $575 million in biobucks.

3. AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore

Meanwhile, AZ has unveiled plans to build a $1.5 billion antibody-drug conjugate manufacturing facility in Singapore. The site, expected to be operational by 2029, will become the company’s first end-to-end ADC production site. The move comes shortly after CEO Soriot said AZ is building separate drug supply chains for China and Western countries amid geopolitical risks. In recent years, Singapore has become a hot destination for biopharma manufacturing expansions.

4. FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo

The FDA has rejected Jiangsu Hengrui Pharma and Elevar Therapeutics’ respective applications for PD-1 inhibitor camrelizumab and the VEGFR inhibitor rivoceranibVEGFR inhibitor rivoceranib for use as a combination in first-line liver cancer. The FDA cited unresolved issues from the inspection of Hengrui’s manufacturing facility for camrelizumab as well as unfinished clinical trial site inspections. The partners aim to refile as soon as possible.

5. Takeda gets crafty with $1.2B biobucks deal to create molecular glues with Degron

Takeda has signed a $1.2 billion biobucks deal with Shanghai’s Degron Therapeutics to work on molecular glue degraders for multiple targets in oncology, neuroscience and inflammation. Degron will use its GlueXplorer platform to find the new glues for therapeutic targets selected by Takeda. Degron has an in-house pipeline, including five early-stage molecular glue candidates in oncology.

6. Otsuka pulls plug on Alzheimer's agitation drug after 2nd failed trial

Otsuka has officially ended development of AVP-786 after the NMDA receptor antagonist failed to move the needle in agitation associated with Alzheimer’s disease in a phase 3 trial. Otsuka obtained the drug from its $3.5 billion acquisition of Avanir Pharmaceuticals in 2015, which also gave the Japanese pharma Nuedexta for the rare disorder pseudobulbar affect.

7. Merck KGaA unit avoids DOJ prosecution after exposing scheme to divert drugs to China

Two Florida residents pleaded guilty to conspiring to “fraudulently procure deeply discounted products” from Merck’s KGaA’s Sigma-Aldrich and ship them to China using faked export documents. The Department of Justice decided not to prosecute the German firm’s life science division, MilliporeSigma, because the company quickly disclosed the scheme and cooperated with the government’s investigation.

8. Chinese CDMO Asymchem expands footprint with deal to take over former Pfizer UK site

China’s Asymchem Laboratories inked a deal to purchase a former Pfizer small molecule API pilot plant and part of its development labs in Sandwich, England. As part of a bigger cost-cutting scheme, Pfizer last year laid off 500 staffers at the plant. The purchase marks Asymchem’s first foray into Europe, and the firm expects to hire 100 workers by the end of the year, including many former Pfizer employees.

Other News of Note:

9. Bristol Myers lines up Opdivo treatment in Pakistan, Rwanda and beyond as part of 10-year access campaign

10. Astellas, Yaskawa Electric Corporation ink pact to explore automated cell therapy production

11. Serum Institute deploys first doses of Oxford, Novavax-partnered malaria shot to Africa

12. No treachery here: Celltrion signs 'The Traitors' star Mollie Pearce for bowel disease campaign

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