By Jeffrey A. Newman
China controls the American generic drug supply chain. For example, China is the key supplier of active pharmaceutical ingredients (API) and as a result, the U.S. generic drug market is as much of a wholly owned subsidiary of Chinese and Indian drug makers. According to stanford Professor Drew Endy, about 90% of our generic antibiotics come from China. China also supplies the U.S. with approximately 30 percent of its active pharmaceutical ingredients, the raw ingredients found in medicines that make them function, according to the American Hospital Association. Now China’s biotech industry is swiftly developing new drugs for cancer and other diseases that are surpassing some major U.S. drugs.
The US relies on China for more than 75 percent of its vitamin B6, B12, B1, C and nearly 70 percent of its vitamin E imports. Chinese imports account for a significant proportion of U.S. prescriptions and over the counter drugs. Many of the Chinese-produced drugs are generics, which account for 91 percent of prescriptions dispensed in the U.S.
In September, Akeso, a Chinese biotech company that developed a new lung cancer drug. Ivonescimab, the drug, was found to have have outdone Keytruda, the medication developed by Merck that has earned more than $130 billion in sales for the the company that has dominated cancer treatment. Patients treated with Akeso’s new drug went 11.1 months before their tumors began to grow again, compared with 5.8 months for Keytruda, according to clinical data released at the World Conference on Lung Cancer, a top medical forum.
Over the past 5 years, China’s companies have started to innovate with more advanced drugs that can compete directly with the Western offerings. In addition, they’ve signed billions of dollars in licensing deals with Western partners to get their products to the rest of the world. There have been dozens of significant Chinese-Western drug licensing deals, such as J&J’s licensing of Carvykti from the Chinese company Legend biotech. . Carvykti is now FDA-approved for the treatment of multiple myeloma. Approved by the FDA in February 2022, Patients with advanced multiple myeloma now have a second option for CAR T-cell therapy, a type of personalized immunotherapy. On February 28, the Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for adults with multiple myeloma that is not responding to treatment (refractory) or has returned after treatment (relapsed). In 2023. Results from the Phase III CARTITUDE-4 trial show Carvykti (ciltacabtagene autoleucel) is the first and only cell therapy to show an overall survival benefit compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma.
Jeff Newman JD MBA, represents whistleblowers in major tariff fraud casesconcerning imported Chinese goods. His firm also represents whistleblowers in Medicare and Medicaid fraud cases under the False Claims Act (Qui Tam), and SEC, IRS and FINCEN whistleblower programs. He can be reached at Jeff@JeffNewmanLaw.com or at 617-823-3217
