FiercePharmaAsia—Chloroquine COVID-19 trial, import leniency, export ban; BeiGene’s Abraxane woe

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Chloroquine, BeiGene, Merck KGaA and Enhertu made our news this week. (Google)

Despite President Donald Trump's optimism around malaria drug chloroquine's potential against the novel coronavirus, the drug has failed a study in mild patients in China, though there's still reason to believe the treatment deserves further testing. The FDA has lifted an import alert on India's Ipca Laboratories so that it can send chloroquine to the U.S., but the Indian government has decided that no such drug should leave its border. BeiGene's Abraxane has been suspended after Chinese inspectors found problems at licenser Bristol Myer Squibb's contract manufacturer Fresenius Kabi's plant in Illinois. And more.

1. Did chloroquine really fail a COVID-19 study—or was the trial design to blame?

Top COVID-19 aspirants chloroquine, AbbVie's Kaletra and a flu drug disappoint in clinical tests

A Chinese study on 30 mild COVID-19 patients showed that adding hydroxychloroquine—an anti-malaria drug highlighted by President Donald Trump as a promising coronavirus therapy—on top of conventional therapy didn’t offer additional benefits such as shortening the time to viral clearance. But the use of other antivirals, such as AbbVie’s HIV med Kaletra and flu drug Arbidol, might have muddied the waters. Kaletra and Arbidol have disappointed in a separate China study.

2. India denies the export of the drug Trump keeps touting for COVID-19

FDA frees India's Ipca from import ban so it can ship unproven COVID-19 treatments 

To boost supply in the U.S. of potential COVID-19 treatment chloroquine, the FDA has made an unconventional move to lift an import alert on India’s Ipca Laboratories. The agency in 2015 banned the company’s products because of data manipulation and a “cascade of failure.” But the agency’s generosity may be for nothing. India’s commerce department has stopped exports of the malaria drug.

3. BeiGene's supply of Bristol Myers Squibb's Abraxane freezes in China amid Fresenius Kabi plant woes

BeiGene’s $100 million-a-year Abraxane sales are under threat. Chinese drug regulators have suspended importation, sales and use of the chemo the company licenses from Celgene—now part of Bristol Myers Squibb—after inspectors found problems at contract manufacturer Fresenius Kabi’s sterile injectables site in Illinois. As a result, the drug has been kicked out of China’s bulk procurement program as two copycats take over.

4. Merck KGaA beats out Novartis with targeted lung cancer nod for Tepmetko in Japan

Merck KGaA’s MET inhibitor Tepmetko (tepotinib) has won its first global nod in Japan to treat non-small cell lung cancer patients with MET exon 14 skipping mutations. The OK came as Novartis’ rival drug, capmatinib, is still under FDA priority review. Merck’s EMD Serono said it plans to file its drug with the U.S. agency in 2020.

5. Astra, Daiichi's Enhertu shows early promise in HER2 lung cancer

After winning a quick FDA nod for breast cancer and beating chemotherapy in stomach cancer testing, AstraZeneca and Daiichi Sankyo’s Enhertu also showed early promise in lung cancer. The HER2-targeting antibody-drug conjugate triggered a response in 55.6% non-small cell lung cancer patients in a small phase 1 study. The effect was most pronounced in those with HER2-mutant NSCLC.

6. India investing $1.3B to cut dependence on Chinese APIs

As the COVID-19 outbreak puts pressure on API prices and supplies, India is now building independence. The government is setting up a 100-billion-rupee ($1.3 billion) fund to produce more APIs within the country, Bloomberg reported.

7. China biotech Laekna snaps up Novartis PD-L1 cancer therapy

Still looking for a piece of the checkpoint inhibitor pie, Shanghai-based Laekna Therapeutics has licensed Novartis’ phase 1 anti-PD-L1 drug FAZ053. The company’s now planning combo therapies across a range of unidentified cancers.

8. Takeda puts down $44M for Evox’s exosome tech in rare disease (release)

Takeda has signed on Evox Therapeutics for developing up to five protein replacement and mRNA therapies for rare diseases with the help of the Oxford, U.K.-based biotech’s exosome targeting and delivery technology. Takeda’s paying $44 million upfront.

9. Shanghai oncology biotech Abbisko nets $70M series C led by Temasek (release)

Abbisko Therapeutics has completed a $70 million series C led by Temasek, bringing the Shanghai oncology specialist’s total financing haul to $140 million. The money will be used to advance the company’s four clinical programs and research into targeted areas and immuno-oncology.

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