Shandong Zhitai: Diphenhydramine Hydrochloride Injection. Recently, the NMPA (National Medical Products Administration) issued a public notice that the diphenhydramine hydrochloride injection applied for by Shandong Zhitai Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Shandong Zhitai") has been officially approved, becoming the first company in China to pass the "deemed to have passed the consistency evaluation" for this drug . Diphenhydramine hydrochloride injection is not a new drug; it already had approval in China as early as 2002. As a first-generation antihistamine, it has a stable clinical position in the treatment of allergies, sedation, and motion sickness. However, the path to consistency evaluation for this old drug has been exceptionally bumpy. According to Yaozhi data, as of now, a total of 12 companies have submitted applications for marketing authorization or consistency evaluation for this drug to the NMPA. Of the 9 companies that have received results, 5 were rejected. A rejection rate of over 50% is quite rare for a mature generic drug, suggesting that regulators have set extremely high red lines for technical reviews.
Prior to Shandong Zhitai, Shanghai Zhaohui Pharmaceutical passed the generic drug quality and efficacy consistency evaluation in July 2025, becoming the first existing company to "pass the evaluation." Shandong Zhitai's approval this time was based on the chemical drug registration classification (new registration classification), directly obtaining "deemed passed" status. Thus, this product now has a "1 passed (Zhaohui) + 1 deemed passed (Zhitai)" pattern of passing the evaluation. Currently, there are 23 companies with approvals for this product, but the actual market power is highly concentrated. Data from the pharmaceutical full-terminal sales analysis system shows that diphenhydramine hydrochloride injection is a typical "hospital-use product," with almost no retail market share. Since 2022, sales of this product have begun to climb significantly, exceeding 300 million RMB in 2024.
In this wave of growth, Guangzhou Baiyunshan has taken the lead, holding more than 50% of the market share. In the local centralized procurement in 2025, Baiyunshan made even greater strides, winning bids in more than 15 regions, further consolidating its entry barriers in various provinces.
With Shandong Zhitai's approval, the competitive landscape for diphenhydramine hydrochloride injection has met the initial threshold of "1+1" (one original/reference manufacturer + one generic manufacturer) or a similar "2+1" requirement, and is only one step away from triggering the "3+1" or "4+1" threshold for national volume-based procurement. For Shandong Zhitai Pharmaceutical, the value of being the first to receive approval is mainly reflected in the following aspects: First, it qualifies it to participate in subsequent local centralized procurement bidding, allowing it to leverage price advantages to gain market share; second, given the rejection of other applicants, being the first to receive approval means the ability to quickly establish channel partnerships; third, being the first to pass the evaluation helps build brand awareness among doctors, laying the foundation for subsequent academic promotion. However, it should be noted that considering 23 companies already hold approval for this product, Shandong Zhitai Pharmaceutical will still face competitive pressure from established companies in actual market expansion. Changes in the market landscape require time to accumulate.

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