Big pharma’s off-patent drugs lose out in China’s new price-cutting scheme

In a Battle of Waterloo-style defeat, off-patent drugs from big pharma firms lost major markets in China as the government adopted a novel procurement scheme to slash generic drug costs. But after steep price cuts, local firms aren’t considered winners, either. In the end, only AstraZeneca’s EGFR inhibitor Iressa and Bristol-Myers Squibb’s heart drug Monopril won their fights against local copycats.

Among the 31 drugs China’s newly formed health insurance watchdog listed for procurement in a pilot program, multinational pharmas participated in bidding to supply almost all of them, but landed only two contracts, according to multiple local reports of preliminary tender results. (See more details on FiercePharma)

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Chinese heparin maker banned by EMA over contamination risks

World regulators are cautious about crude heparin after China-made APIs were responsible for dozens of deaths in the U.S. more than a decade ago. Now, European regulators are banning heparin from a Chinese facility after finding 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, Sichuan, China, during an October inspection.

There are few details in the report the EMA posted to its EudraGMDP site, but it said investigators found two dozen violations, seven of them major, at the maker of crude heparin, an anticoagulant. Those included risk of contamination, unsatisfactory traceability of starting material, poor materials management and recovery of solvents as well as issues with buildings, facilities, equipment and storage.

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

A U.S. biotech that bought a portfolio of nearly 30 generic drugs from Sandoz in January says it has plans to build its first manufacturing facility in China, where it has focused much of its drug development efforts.  

Rockville, Maryland-based CASI said on Friday that it “has entered into framework agreements” to build a manufacturing site at the Wuxi Huishan Economic Development Zone in Jiangsu Province, China.

CASI provided no details about the agreements in terms of cost or size of a facility, saying only that it expects construction to begin in the middle of 2019 and the facility will be able to handle large-scale production.

“We are excited about moving forward with building our own manufacturing site as part of our supply chain,” CASI Executive Chairman Wei-Wu He, Ph.D., said in a statement. “The facility will be a core component of our long-term growth strategy as it will give us significantly greater capacity in order to meet the company’s commercial needs, and also will allow us greater control over quality, cost of goods and to accelerate production schedules.”

China slaps monstrous $1.3B penalty on vaccine scandal culprit Changsheng

Heralding an end for Changchun Changsheng Life Sciences, whose name literally means “long life,” a furious Chinese government handed out its verdict on the company’s role in a high-profile vaccine scandal that provoked nationwide anger and doomed the careers of several top-ranking government officials.

The Changchun, China-based vaccine maker will be fined a whopping 9.11 billion Chinese yuan ($1.32 billion) on eight violations of drug regulations, China’s National Medical Products Administration said in a release (Chinese) Tuesday as the agency concluded its investigation.

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The sheer size of the punishment—rarely seen, if not unprecedented in China’s biopharma history—shows just how far Beijing is willing to go to placate public anger and deter future offenders that could damage its drug industry’s reputation.

Confirming what the agency had found during an on-site probe, the charges said Changsheng mixed different batches of active vaccine ingredients, including expired ones; failed to run proper efficacy tests; fabricated vaccine production dates; and manipulated or destroyed original records to cover its tracks. (cr. FiercePharma)

 

Litigation teaches Chinese valsartan maker the downside of U.S. market

China’s Zhejiang Huahai Pharmaceutical for years enjoyed the upside of the U.S. pharmaceutical market, selling its valsartan API to drugmakers producing blood pressure meds for the market. Now it is seeing the downside, having its products banned by the FDA and facing litigation over the discovery of a suspected carcinogen in its API.

The Chinese company disclosed (PDF) to the Shanghai Stock Exchange that it has been named in multiple lawsuits, according to a translated copy of the filing. The FDA said it has put Huahai on its import alert list, banning its products from the U.S. The company, whose APIs are in about half of the valsartan blood pressure medicines sold in the U.S., last summer instigated a global recall of its products. While the levels of NDMA in Huahai’s valsartan API were trace amounts, they were considered unacceptable, the FDA has said. Further testing has also found N-Nitrosodiethylamine (NDEA), another suspected carcinogen, in the API. (cr: FiercePharma)

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Chinese API maker Jiangsu Yew Pharma suspended for refusing Hungarian inspectors

Some drugmakers get cited for handling manufacturing or testing poorly. Others are cited for refusing to even to let authorities get a look at what they are up to.

Chinese API maker Jiangsu Yew Pharmaceutical, based in Yixing City, China, had its European marketing authorization suspended for refusing to allow Hungarian inspectors into a manufacturing facility during a visit in late June, according to a posting on the European Medicine Agency’s Eudra GMDP website.

Among the products produced at the facility is an active substance intermediate ingredient in temozolomide, which is used in oral chemotherapy drugs designed to treat some brain cancers as well as glioblastoma multiforme and astrocytoma.

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

Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry’s biggest names.The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.

The list of “clinically urgently needed new drugs” was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China.

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According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or because they’ve shown clear advantages in clinical studies.

See more details on FiercePharma