FDA Grants Emergency Authorization to Chinese-Made Cisplatin Amid U.S. Cancer Drug Shortage

The ongoing trade friction between China and the U.S. continues to impact the globalization of the pharmaceutical supply chain. Over the past period, the U.S. has been emphasizing the security of its pharmaceutical supply chain, attempting to localize pharmaceutical production that has already become globalized. However, it has proven that the normal operation of the U.S. pharmaceutical industry cannot function without cooperation with China's pharmaceutical industry.

Recently, Qilu Pharmaceutical's Cisplatin Injection received FDA special approval for rapid market entry in the United States, becoming the 24th formulation product exported to the U.S. by Qilu Pharmaceutical.

Qilu Pharmaceutical's Cisplatin Injection, after receiving special approval for rapid market entry, will be temporarily distributed in the U.S. by Canadian pharmaceutical company Apotex in 50-milligram vials. Starting from this Tuesday (June 5, 2023), healthcare workers in the U.S. can place orders.

"FDA recognizes the importance of a stable and secure supply of critical oncology drugs, particularly those used in potentially curative or life-extending situations," FDA expert Dr. Robert Califf commented on Twitter.

"Today, we have taken measures to temporarily import certain foreign-approved versions of cisplatin products from FDA-registered facilities and are using regulatory discretion to continue the supply of other cisplatin and carboplatin products to help meet patient needs," added Dr. Robert Califf. "In these situations, we carefully evaluate product quality and require companies to take certain actions to ensure the safety of the products for patients. The public can be assured that we will continue to do everything possible to assist the industry in producing and distributing these drugs to meet all patient needs for oncology drugs affected by shortages."

Behind the FDA's expedited approval for Qilu Pharmaceutical's Cisplatin Injection is the shortage of Cisplatin in the U.S. market.

Cisplatin, a generic drug with decades of history in the U.S., has been in short supply since an Indian pharmaceutical company temporarily halted its production for the American market in February this year.

According to data from the U.S. National Cancer Institute (NCI), 10% to 20% of cancer patients are treated with cisplatin and other platinum-based drugs. The cure rate for cisplatin in treating testicular cancer exceeds 90%. It is also used to treat bladder cancer, cervical cancer, ovarian cancer, lung cancer, stomach cancer, breast cancer, and head and neck cancers.

Johns Hopkins School of Medicine professor Amanda Fader told CNN that the severe shortage of cisplatin and carboplatin, the "backbone drugs" of chemotherapy, is affecting hundreds of thousands of cancer patients in the United States.

Notably, Qilu Pharmaceutical's cisplatin injection has not received formal FDA approval for marketing. However, an FDA spokesperson stated that the agency thoroughly evaluated the quality of the imported drug not yet formally approved to ensure its safety for American patients. Apart from cisplatin, at least 13 other anticancer drugs in the U.S. are currently in short supply.

Qilu Pharmaceutical's Cisplatin Injection Receives FDA Special Approval, Another Positive Signal of Easing Trade Friction in Pharmaceutical Field Between China and the US.

The pharmaceutical supply chain in the United States is highly dependent on global outsourcing. According to the 100-day supply chain review document released by the U.S. in June 2021, as of March 2021, 52% of the U.S.'s drug product manufacturing facilities and 73% of its active pharmaceutical ingredient (API) manufacturing facilities are located outside the U.S., with 6% of drug product manufacturing facilities and 13% of API manufacturing facilities based in China.

For ANDAs, 63% of drug product manufacturing facilities and 87% of API manufacturing facilities are located outside the U.S., with Chinese drug product facilities accounting for 8% and API facilities accounting for 16%.

In terms of numbers, China plays an important role in the U.S. biopharmaceuticals and active pharmaceutical ingredients (API) supply chain, but its outsourcing system is a product of its own economic ecosystem.

But in recent years, the United States has introduced a series of measures in an attempt to change this established system. On September 12, 2022, U.S. President Biden signed an executive order on national biotechnology and biomanufacturing, with the aim of “ensuring that we can manufacture and produce all the products we invent in the United States.” (For more details, see: Biden Launches National Biotechnology and Biomanufacturing Initiative to Ensure “Production of All Products Within the Country”)

Later, there were rumors that the biotechnology industry had become one of the five industries restricted for U.S. investment in China. Moreover, Chinese capital seeking to acquire U.S. Biotech companies has also faced numerous review-related challenges.

But since the beginning of this year, positive signals have emerged in investment. First, the IPOs of U.S.-listed Chinese biotech stocks, which had been suspended for over a year, have resumed. Three Chinese biotech companies—Structure Therapeutics, YishengBio, and CrownBio—successfully went public on Nasdaq through SPACs.

Secondly, in the field of cross-border mergers and acquisitions, there is positive news regarding Chinese acquisitions of U.S.-based biotech companies. On March 7, 2023, F-Star Therapeutics announced that the U.S. Committee on Foreign Investment ("CFIUS") had approved the acquisition of F-Star Therapeutics by invoX Pharma Limited, a wholly-owned subsidiary of China Biologic Products. With this approval, the transaction has now received all necessary regulatory approvals, and both parties expect the acquisition to be completed promptly.

Since China Biologic Products announced on June 23, 2022, its plan to acquire F-Star Therapeutics, the deal has been continuously delayed due to CFIUS review. This cross-border acquisition between China and the U.S., with its many twists and turns, has undoubtedly experienced and witnessed the process of the China-U.S. biotech cross-border mergers and acquisitions moving from a freezing point to a recovery.

In addition to this deal, more China-US cross-border mergers and acquisitions in the biotechnology sector were completed in 2023. On January 6, 2023, Sirio Healthcare announced that the company had finalized the acquisition of Best Formulations LLC, a U.S.-based health product CDMO company. After the completion of the transaction, Sirio Healthcare held 71.41% of the target company's equity through its indirectly wholly-owned subsidiary, Sirio Healthcare Holdings LLC.

On April 23, 2023, Grand Pharmaceutical announced that it had recently signed an equity acquisition agreement to acquire 87.5% of the equity in BlackSwan Vascular, Inc. (BlackSwan), a U.S.-based company, from its original shareholders for no more than 37.5 million USD. Upon completion of the transaction, BlackSwan will become a non-wholly owned subsidiary of Grand Pharmaceutical, which will also hold global rights to two embolization products (Lava and Kona).

On April 18, 2023, according to the U.S. political news media Politico, China's biotechnology industry may not be subject to U.S. investment restrictions in China.

Today, the U.S. FDA's special approval of a Chinese anti-cancer drug for market release to address shortages also demonstrates that the interests of China and the U.S. in the biopharmaceutical field are highly aligned, and cooperation is the optimal choice for all parties involved.