Two More Rejected: Generic Drug Pass Rate Plummets Below 20% in China

China's drug regulatory landscape delivered a mixed bag this week, with a wave of approvals alongside a sobering reminder of the challenges facing generic drug makers. Between June 13 and 18, the National Medical Products Administration issued approvals for several new drugs and indications, while the approval pass rate for certain generic applications remained stubbornly low.

The week opened on June 15 with a batch of approval certificates, including multiple new drugs that signal continued momentum in China's pharmaceutical innovation.

Premature Ejaculation Drug Duo Takes Shape

Plethora Solutions, in partnership with Shanghai Fosun Pharmaceutical (Group) Co., Ltd., secured approval for a 5.1-class drug: a lidocaine-prilocaine aerosol spray for the treatment of primary premature ejaculation in adult males. This marks only the second drug approved for this indication in China, joining dapoxetine on the market.

Hengrui's CDK4/6 Inhibitor Gains Third Indication

Hengrui Medicine's self-developed CDK4/6 inhibitor, dalciclib hydroethanesulfonate tablets, received approval for a new indication, bringing its total approved uses to three. The expansion underscores the drug's growing role in oncology treatment.

CSPC's Paclitaxel Breakthrough

CSPC Pharmaceutical Group Limited achieved a notable milestone with the approval of its albumin-bound paclitaxel injection (Type II), described as the world's first fast-dissolving albumin-bound paclitaxel formulation. The company positions this as the first formulation iteration for paclitaxel-based drugs in 21 years, representing a significant advance in drug delivery technology.

June 16 Notification Letters: A Harsh Reality

The following day brought a different story. On June 16, the administration issued a wave of notification letters, including China Resources Sanjiu's improved new drug ambroxol hydrochloride freeze-dried tablets and several traditional Chinese medicines. But the headlines belonged to the rejections.

Two applications for N-acetylcysteine injection and one for dimethicone emulsion received notification letters indicating failure. The data tells a stark story: across all N-acetylcysteine injection applications, 27 have failed while only four succeeded, yielding a pass rate of less than 20 percent. This abysmal success rate explains the week's grim headline.

CSPC's GLP-1 and Hypertension Patch Moves

CSPC Pharmaceutical Group continued its aggressive filing strategy. The company submitted a new indication application for its GLP-1 drug this week, widely speculated to target type 2 diabetes. More intriguingly, CSPC filed a 5.1-class listing application for a bisoprolol patch, an external hypertension treatment. Originally approved in Japan in 2013, the patch format represents a novel delivery approach for blood pressure management in the Chinese market.

Indian Challenger Enters Inhalation Space

Indian pharmaceutical giant Cipla made a bold move, filing listing applications for budesonide-formoterol inhalation aerosols (Types I and II). These high-difficulty inhalation formulations have seen limited domestic competition in China. Cipla's entry signals growing international interest in China's complex generic drug market.

Crowded Pipeline: Landiolol and Naftamostat

Applications accepted after May 15 revealed intensifying competition in two therapeutic areas. Landiolol hydrochloride for injection has now attracted its eighth applicant, while naftamostat mesylate for injection has drawn its sixth. Both drugs face increasingly crowded markets, setting the stage for fierce competition once approvals are granted.

The week's regulatory activity paints a picture of a market in transition: innovation continues to advance with new drug approvals and expanded indications, while generic drug makers face mounting challenges in navigating China's increasingly stringent approval processes. For companies eyeing the Chinese market, the message is clear: quality and differentiation matter more than ever.