Multiple Well-Known Imported Drugs Actively Withdraw From China Market

On the evening of October 15, the National Medical Products Administration issued an announcement canceling the registration certificates of 80 drugs, including Fexofenadine Loratadine Tablets (10mg, National Drug Approval Number H20040557).

It is noteworthy that these drugs are all "cancellation upon request"—meaning the companies voluntarily submitted cancellation applications, rather than having their licenses revoked due to safety or quality issues. Once the registration certificate is canceled, the production and sale of the relevant drugs will cease.

Approximately 55% of the drugs being deregistered this time come from foreign or joint venture pharmaceutical companies, reflecting that the strategic adjustments of multinational pharmaceutical companies in the Chinese market are still ongoing. With the advancement of the national centralized procurement system and the rise of domestic companies, some older products from foreign pharmaceutical companies are gradually exiting the market.

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Multiple blockbuster drugs withdrawn

The list of cancellations includes many well-known brands and varieties.

GlaxoSmithKline (GSK)'s Ventolin (salbutamol sulfate inhalation solution)

Pfizer's Doxorubicin Hydrochloride for Injection

Sanofi's GLP-1 type hypoglycemic drug Lixisenatide injection (Lyxumia)

BioMarin's rare disease drug elosulfase alfa injection

Margenza (margetuximab-cmkb) injection from Zai Lab

And hemorrhoid medicine "Taining Suppository," etc.

The withdrawal of most drugs is related to adjustments in business strategy, raw material shortages, or declining sales.

The underlying reasons behind foreign pharmaceutical companies' voluntary "exit"

Industry insiders point out that original research drugs often face a "dilemma" after entering the national centralized procurement system.

If choosing to lower the price to win the bid, the profit margin will be significantly compressed.

If the centralized procurement is refused, the market share will be quickly replaced by domestic generic drugs.

For example, original drugs like loratadine, metformin, and atorvastatin have now largely been replaced by domestic generic drugs in centralized procurement.

Currently, the prices of drugs awarded in centralized procurement are generally 70% to 90% lower than those of the original branded drugs, with the prices of some drugs even dropping to single digits.

Boehringer Ingelheim, for example, proactively canceled a series of marketing authorizations for empagliflozin and metformin tablets, effectively opting out of the upcoming eleventh batch of centralized procurement.

Policy optimization leads to more rational competition.

Although the withdrawal of multinational pharmaceutical companies from the market has attracted attention, the volume-based procurement policy is being continuously optimized.

Guarantee the right to choose medications: The eleventh batch of centralized procurement allows medical institutions to report quantities by brand. After selection, they can be supplied directly, providing hospitals with greater choice.

Respect clinical needs: If the indications for a generic drug are fewer than those for the original drug, the quantity requirements will be reduced to ensure rational drug use.

Maintain market flexibility: Non-basic medical insurance service drugs are not included in centralized procurement monitoring, and original drugs still have room for survival.

Strengthen quality supervision: Enhance the requirements for corporate quality systems, increase sampling inspections of selected drugs, and ensure drug safety and reliability.

Balance under the trend of domestic substitution.

Globally, the replacement of patent-expired imported drugs with generic drugs is a common practice in the industry.

The funds saved from centralized procurement are also expected to be redirected to support the clinical accessibility of innovative drugs and rare disease medications.

The patient's concern is also reasonable: cheaper medication does not necessarily mean the same efficacy.

Retaining some imported drugs not only increases patient choices but also encourages domestic pharmaceutical companies to improve quality and consistency evaluation.

The voluntary cancellation of 80 drugs this time is not only a business decision by individual companies but also reflects the deep transformation of the Chinese pharmaceutical market.

From "original research-led" to "domestic rise," from "price competition" to "quality competition."

In the future, finding a balance between price reduction, quality, and innovation will determine the long-term landscape of the entire industry.