Wednesday, January 8, 2025

Confirming An Improving Regulatory Trend In China, Gardasil® Is Now Approved By China's FDA -- For Men -- Not Just Women.

In early November '24, we mentioned that we thought the pessimism about Gardasil® sales in China (on Wall and Broad) was being overstated. Today's news confirms that view.

You see, much of the decline in China's HPV vaccine sales previously seen was due not so much to organic demand factors, but a sharp state-actor / regulatory crackdown by Xi, on many US companies' Chinese network of distributors, of all sorts of drugs. [We covered that, here.]

Gardasil was particularly hard hit when ZFSW, the largest in-country distributor of Gardasil was nearly closed (due to concerns about alleged hospital kickbacks), by Chinese authorities. It is resolved, and yet it is taking a moment to rebuild rapport with hospital buyers, in this vast, sprawling Asian nation. . . but that effort is well-underway. [Hospitals themselves often fear state-actor reprisals, when there are stock-outs and the like.] Even so, as they say in China, "the mountains are high, and the emperor is very far away". . . .

In any event, here's Reuters, on the latest "in China" clearance:

. . .Merck's human papillomavirus vaccine has been approved for men in China, it said on Wednesday, providing the U.S. drugmaker a much-needed boost in a key market where demand has been falling among women. The shot, Gardasil, is already approved for women, but the vaccine's distributor in China has reduced stock due to weak demand.

Merck [at Q3 2024] said weak sales in China were likely to continue in 2025. . . .

This is the first HPV vaccine for men to be approved by China's National Medical Products Administration and can be used by children and men aged between 9 and 26 years to prevent certain cancers and HPV-related diseases, the company said. HPV is a common cause for cervical cancer in women, while it increases the risk of genital warts and several types of cancers among men. . . .


Onward -- grinning into the warming sunshine here -- above zero on the wind chills, finally! And at 2 PM EDT today we will learn whether "Hizzoner" should even bother to show up for trial in Manhattan federal court, given the number of adverse inferences to be drawn, and the potential lack of any exhibits, since he's missed all deadlines to provide them. Delicious.

नमस्ते

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