FiercePharmaAsia—Lenvima growth; China’s drug invite; Samsung’s biologics commitment

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Eisai, China's urgently needed drug list, Samsung, Teva and Celltrion made our news this week. (Google)

Eisai enjoyed strong growth from Merck & Co.-partnered Lenvima in the three months ended in June, with major contributions from the U.S. and Japan. China made a list of 48 drugs already approved abroad, calling for their makers to apply for expedited Chinese nod based on foreign trial data. Samsung unveiled $22 billion investment plan with focus across business lines, including biologics. And more.

1. Eisai's Lenvima posts big growth numbers as Merck collaboration rolls into action

Eisai’s Lenvima raked in about $106 million in the April-to-June quarter. More than half of that haul came from the U.S., where sales swelled by 42.8%, thanks to indications in kidney cancer and thyroid cancer. The drug also expects an FDA liver cancer decision soon, and it is being tested with partner Merck & Co.’s Keytruda in 11 indications across seven cancer types.

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2. China targets Cosentyx, Shingrix and Luxturna and 45 other drugs for priority approval

China’s drug reviewers rolled out a list of 48 drugs greenlighted abroad. The idea is to persuade their makers to apply for Chinese approval based on foreign trial data. Besides a few industry big names already on the market for years, some drugs just approved last year in the U.S. were ID’d, including GlaxoSmithKline’s Shingrix, Spark’s Luxturna and Ultragenyx’s Mepsevii.

3. Samsung commits billions of dollars to building its biologics business

Samsung revealed plans to invest $22 billion across business lines, including biopharmaceuticals, along with artificial intelligence and auto electronics. The company said it will continue to “invest heavily” in its CDMO and biosimilar businesses. With completion of the third facility, Samsung BioLogics will have total capacity of 362,000 liters and will have invested about $2.6 billion.

4. Teva confident in September approval for migraine drug despite latest Celltrion plant citation

After reinspecting a Celltrion plant that had previously been served a warning letter, the FDA issued a Form 483. Celltrion said the observations are “manageable and correctable,” and Teva said it’s on track to get approval next month of its highly anticipated migraine drug, fremanezumab, which will be made by the Celltrion plant. Though analysts have different opinions.

5. Dendreon changes hands—again—in $868M deal that keeps seller Sanpower in the game

About a year after acquiring Dendreon from Valeant for $820 million, China’s Sanpower Group has resold the Provenge maker in a deal worth about $868 million. After the transaction, Sanpower’s stake in the buyer, public firm Nanjing Cenbest, grew to 42.43%. The deal will give Dendreon easier access to funding for expansion down the road, said Dendreon’s chairwoman.

6. Tainted valsartan has been on the market for 4 years, FDA discovers

China’s Zhejiang Huahai Pharmaceutical set off a global recall after it informed global regulators last month that it had discovered suspected cancer-causing residue in its valsartan API. Now, the FDA said drugs with the impurity may have been sold for four years.

7. Janssen, Bayer to close South Korean plants due to limited demand

Janssen Korea will shutter its Hyangnam plant in Hwaseong, South Korea, by 2021. According to a local report, the closure is a strategic decision made over limited needs for solid-dosage drugs. Meanwhile, Bayer is closing a Korean plant that makes contrast media hopefully by the end of the year.

8. Liver-focused Ambys launches with $140M, Takeda partnership

Third Rock Ventures launched Ambys Medicines, which will develop cell and gene therapies as well as drugs for chronic liver diseases. Of the $140 million Ambys secured in committed capital, $100 million will come from Takeda, which has the option to the ex-U.S. rights for the first four products.

9. Could a dose of blockchain prevent China’s vaccine production data problem?

As a vaccine production scandal enrages Chinese citizens, a blockchain-based drug and vaccine traceability system called VeChainThor Blockchain is preparing its debut in Shanghai. Experts say blockchain’s tamper-resistant quality is perfect for manufacturing record-keeping, and so reducing data manipulation in drugmaking.

10. On a roll at FDA, Kyowa Kirin wins nod for Poteligeo, its drug for hard-to-treat lymphoma

Months after an FDA nod for Ultragenyx-partnered blockbuster hopeful Crysvita, Kyowa Kirin has nabbed U.S. approval for Poteligeo to treat two rare types of non-Hodgkin lymphoma. The drug has been on the Japanese market since 2012, and Kyowa Kirin is testing it with Opdivo and Imfinzi in solid tumors.

11. Pharma reps get more respect from doctors in Japan. What's the takeaway for U.S. reps?

A recent research showed pharma sales reps have broad reach and influence with doctors in Japan. Japanese physicians are still the boss, but because no direct-to-consumer ads are allowed, physicians rely on face-to-face interaction with sales rep to get critical information. For selling drugs in the U.S., that means “finding your niche and targeting it,” said a research leader.