FiercePharmaAsia—Gene-edited babies; Takeda-Shire countdown; Celltrion’s Rituxan biosim

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The Chinese researcher who gene-edited babies, Takeda, Shire, Celltrion and more made our news this week. (Google)

A Chinese scientist claims to have made the world’s first genome-edited babies, prompting strong criticism from the science community and regulators. The last Takeda founding family member to have run the drugmaker publicly voiced opposition to the $62 billion Shire deal, even after the buyout cleared all regulatory hurdles. Roche will face the first biosimilar to Rituxan soon, a fact underscored by the FDA approval of Celltrion and Teva's version. And more.

1. Chinese researcher claims to have made the first CRISPR-edited babies

Chinese researcher He Jiankui claims his team used CRISPR to make the world’s first genome-edited babies. He said he knocked out CCR5 genes, which HIV uses to enter and infect cells, in embryos that later became twin girls. The revelation immediately drew wide criticism from scientists around the world, and Chinese authorities launched an investigation into potential violations of Chinese laws.

2. Takeda ex-chairman speaks out against Shire buy a week before key votes

Editor’s Corner—The fall of auto czar offers a cautionary tale for Takeda CEO Christophe Weber

With EU blessing, Takeda clears final regulatory hurdle for Shire buyout—on one condition

Takeda investors mount last-minute effort to stymie Shire deal: FT

Citing high risks, former Takeda chairman—and the last member of the founding family to have run the drugmaker—publicly objected to the company’s $62 billion Shire buy, even after the deal had secured all regulatory approvals. A small group of rebel shareholders and former employees are also aiming to gather support from 25% of Takeda investors, hoping to derail the deal at a key vote on Dec. 5.

3. Roche’s patent cliff just got steeper as FDA approves Celltrion’s Rituxan biosimilar Truxima

The FDA approved Celltrion and partner Teva’s Truxima, the first biosimilar to Roche’s blockbuster lymphoma therapy Rituxan in the U.S. In Europe, where biosimilars have already hit, sales of the drug dropped 49% in the third quarter. But Roche’s pharma chief Daniel O’Day said during the third-quarter earnings call that the company doesn’t expect a similar erosion in the U.S.

4. WuXi NextCODE acquires GMI as part of $400M genomics research push in Ireland

WuXi NextCODE is acquiring Genomics Medicine Ireland as part of a $400 million investment that counts the country’s sovereign development fund, the Ireland Strategic Investment Fund, and others as backers. The first installment will be used toward sequencing 400,000 Irish residents’ genomes for insights on diseases. The deal came as NextCODE collected $200 million in series C funding.

5. Sun gets dermatology portfolio, 2 plants in Japan with Pola Pharma deal

Sun closing New Jersey plant, laying off nearly 100, to cut costs in 'competitive' U.S. market

After buying a few brands in Japan from Novartis in 2016, Sun Pharma is acquiring Japanese drugmaker Pola Pharma, getting a portfolio of dermatology products and two plants that can manufacture topical products and injectables, for just $1 million. The Japanese investment came as Sun is planning to close a plant in Cranbury, New Jersey, and cut about 100 workers.

 6. Sanofi hesitance, domestic scandal and company drama cut flu vaccine supply in China

Flu vaccine supply in China this season has come down dramatically. After noticing an efficacy decline in certain batches of its Vaxigrip in the previous season, Sanofi started production this year later than expected, causing its supply to drop about 80%. Meanwhile, former major suppliers Changchun Changsheng Life Sciences and Sinovac Biotech both saw their supplies crash to zero for different reasons.

7. Sanofi flu vaccine batches rejected after inspectors in Taiwan, Hong Kong find impurities: reports

Drug regulators in Taiwan and Hong Kong returned several batches of flu vaccines made by Sanofi, citing suspected impurities. Taiwan FDA found black and white suspended matter in the vaccines and returned about half a million doses, while Hong Kong officials sent back a batch of 175,000 doses.

8. Astellas’ Xospata wins FDA nod in AML, with Daiichi competition looming

Astellas’ Xospata became the first FDA-approved monotherapy for relapsed or refractory AML patients with either one of two different FLT3 mutations. Daiichi Sankyo’s rival quizartinib is closely behind with an FDA decision set for May 25. Both drugs are eyeing the first-line setting, now dominated by Novartis’ Rydapt.

9. Samsung BioLogics strikes back, filing lawsuit over criminal penalties imposed by Korean regulators

Samsung BioLogics has filed an administrative lawsuit against Korea’s Financial Services Commission over penalties the agency slapped on the biologics CDMO related to alleged accounting violations. The FSC had concluded the company hid information about its Biogen-partnered joint venture, Samsung Bioepis, before its IPO.

10. Biohaven sets up Shanghai outpost to handle Asia-Pacific portfolio

Biohaven has created a wholly owned subsidiary in Shanghai, called BioShin, which will develop and commercialize Biohaven’s migraine and neurology assets in China and other markets in the Asia-Pacific region. Its first IND application to Chinese authorities is expected this year.

11. BeiGene bags Asian rights to Zymeworks’ HER2 bispecifics

BeiGene has paid Zymeworks $40 million upfront, with potential milestones reaching $390 million, for Asian-Pacific rights to two HER2-targeted bispecific antibodies. While BeiGene will be responsible for development in the territory, it will also share data with Zymeworks for filings elsewhere.

12. GlaxoSmithKline taps Unilever as lead bidder in Indian Horlicks buyout: report

GlaxoSmithKline has reportedly identified Unilever as the lead bidder for its Indian consumer health business, which includes nutritional beverage Horlicks. While the Financial Times reported that the talks were exclusive, one source told Reuters that GSK could reopen talks with Nestlé.

13. Chinese heparin maker banned by EMA over contamination risks

Italian inspectors recommended the European Medicines Agency pull the manufacturing approval for and ban the heparin from Yibin Lihao Bio-technology after they found significant issues at its facility in Yibin, China, during an October inspection.  

In case you missed them, here are some other stories from the previous week:

1. Eli Lilly weighs $200M-plus sale of declining China drug portfolio: report

2. Roivant takes aim at resistant infections with $667.5M Intron deal

3. China’s Alphamab Oncology pulls off $100M series A

4. Biogen tasks HitGen with discovering neurological leads

5. Johnson & Johnson launches Singapore public-private partnership in nearsightedness research

6. WuXi AppTec opens new medtech testing facility in Suzhou

7. MorphoSys partners anti-C5aR I-O antibody with I-Mab

8. U.S. biotech focused on China to build manufacturing facility there

9. Halaven maker Eisai launches metastatic breast cancer story-sharing campaign