November 2, 2026
Source: drugdu
28

Recently, Sichuan Keruide Pharmaceutical Co., Ltd. received a Drug Registration Certificate issued by the National Medical Products Administration, approving the registration of the company's dexketoprofen tromethamine tablets (25mg and 12.5mg specifications).
For patients, this means that in common mild to moderate pain scenarios such as musculoskeletal pain, dysmenorrhea, toothache, and arthritis-related pain, there is an additional option for prescription drugs and room for adjustment of dosage in clinical practice.
For Keruide, this further completes its pain management product line. Dexketoprofen can be used in conjunction with the already marketed Keruide (tizanidin hydrochloride) to address pain accompanied by muscle spasms from both peripheral anti-inflammatory and central muscle relaxation perspectives, providing orthopedic, rehabilitation, and pain management doctors with a more comprehensive medication combination.
I. What are the approved drugs mainly used to treat?
Dextrokeprofen tromethamine tablets are primarily used for the symptomatic treatment of mild to moderate pain caused by various etiologies, including musculoskeletal pain, dysmenorrhea, toothache, and joint pain associated with diseases such as rheumatoid arthritis, osteoarthritis, and gouty arthritis. They can also be used for pain caused by acute sprains or soft tissue contusions. It is a prescription drug, not a common painkiller that patients can self-diagnose and purchase. Clinical use requires physicians to consider the cause and severity of the pain, any comorbidities, other medications the patient is currently taking, and any contraindications.
The simultaneous approval of two specifications directly benefits clinical use by providing more options. The 12.5mg and 25mg specifications allow doctors to adjust dosages based on patient conditions and offer greater flexibility for combination therapy. However, the specific specification to choose, the daily dosage, and the duration of use should still be determined according to the drug's instructions and the doctor's prescription. Pain management is not simply about "relieving pain"; finding the cause and treating the underlying disease are equally important.
II. Approval of dual specifications is not just about adding another packaging.
The simultaneous approval of two specifications of the same product is not as simple as adding another packaging. It involves multiple stages, including chemical drug research and development registration, quality management, and industrialization preparation. Keruid stated in its public information that it will strictly adhere to drug management laws and regulations and registration management requirements, solidly advance the pre-market production preparation and quality management work for this product, and organize production and sales under the premise of meeting the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals, effectively ensuring product quality and stable supply.
For patients, approval is only the first step. The stability of subsequent production and supply, the clarity of the instructions, and clinical feedback are equally important. For Keruide, this approval of two specifications further enriches the company's product portfolio in the pain management field and demonstrates its comprehensive capabilities in chemical drug R&D and registration, quality management, and industrialization preparation. Adding a product to the pain management product line means the company has a wider range of combinable products for orthopedic, rehabilitation, and pain management applications.
III. How to combine peripheral anti-inflammatory treatment with central muscle relaxation
In the clinical outpatient departments of orthopedics, rehabilitation, and pain management, pain is often not an isolated condition. Osteoarthritis or muscle strain is often accompanied by local muscle spasms. Pain can cause reflex muscle tension, which can in turn affect local circulation and further aggravate the pain. Patients experience "pain," but there may be two underlying factors: peripheral inflammation and central muscle spasms.
Dextromethorphan tromethamine tablets belong to the class of nonsteroidal anti-inflammatory drugs (NSAIDs), exerting anti-inflammatory and analgesic effects by peripherally inhibiting inflammatory responses. Tizanidine hydrochloride tablets/oral solution is a centrally acting skeletal muscle relaxant, suitable for painful muscle spasms associated with localized pain syndromes such as neck, shoulder, and lower back pain. When used together, one provides peripheral anti-inflammatory and analgesic effects, while the other centrally relieves muscle spasms, working synergistically to address both pain and spasm. Public information suggests that this combination helps to further enhance the analgesic effect, providing a more complete medication combination for clinical pain management.
It is important to note that combination therapy is not something patients should decide on their own. Both dexketoprofen and tromethorphan are prescription drugs, and whether they are suitable for combination therapy, and how they should be used, requires evaluation by a doctor based on the patient's specific condition. This is especially true for patients with gastrointestinal, cardiovascular, liver, or kidney problems; their decisions should be made by a doctor. Patients should not purchase and combine medications on their own simply because they see the term "combination therapy."
IV. R&D investment supports the pain management pipeline
Behind this approval lies Kerui's long-term investment in research and development and its accumulated experience in registration. Founded in 2000, Kerui is a national high-tech pharmaceutical enterprise. In October 2026, the company was selected as one of the "Top 100 Private Enterprises in Sichuan in 2026 for R&D Investment," with R&D investment accounting for more than 15% of sales revenue. To date, the company has obtained 139 authorized patents, 22 drug production licenses, 22 API registration numbers, and 5 medical device registration certificates.
These figures demonstrate that Kerui Pharmaceuticals doesn't just focus on a single product, but has accumulated expertise in drug development and registration, active pharmaceutical ingredients (APIs), and medical devices. The approval of dual specifications of dexketoprofen and tromethamine tablets is another achievement of the company's continued deep cultivation in the field of pain management, further confirming its comprehensive strength in moving from single-drug development to multi-pipeline synergistic development. The company also mentioned that it will rely on research platforms such as the Sichuan Provincial Key Laboratory for Central Nervous System Product Development to continuously promote new drug research and technological upgrades. For clinical practice, continued investment in R&D means a potential increase in subsequent product choices; however, after a new drug is approved, its applicability still needs to be tested through real clinical use and physician judgment.
V. What does this mean for clinicians and patients?
The direct significance of this dual-specification approval is threefold. First, it provides another prescription drug option for pain management, covering common pain scenarios such as musculoskeletal pain, dysmenorrhea, toothache, arthritis-related pain, and acute sprains. Second, the additional specification option allows doctors to adjust the dosage according to the patient's condition and provides greater flexibility in combination therapy. Third, it adds a peripheral anti-inflammatory analgesic that can be used in combination with central muscle relaxants to the Kereide pain product line, providing another approach to clinical pain management.
For patients, the most important thing is to avoid self-purchasing or self-combining medications. Dexketoprofen tromethamine tablets are prescription drugs; whether they are suitable, which strength to use, and whether they can be used in combination with ketamine should all be determined by a doctor. Patients can pay attention to drug approval information, but specific medication use must follow the doctor's prescription and instructions. For clinicians, dual-strength approval provides more options, but it is also necessary to consider the individual patient's condition and pay attention to contraindications and adverse reaction risks associated with combined medication.
Korede stated that it will continue to focus on core therapeutic areas, continuously improve its product pipeline, and enhance its R&D innovation and quality assurance capabilities to provide clinicians and patients with more high-quality medication options. Going forward, it is worth paying attention to the product's supply situation after launch, information in the instruction manual, clinical usage feedback, and the applicability boundaries of the "peripheral anti-inflammatory + central muscle relaxant" combination regimen in real-world treatment.
VI. Extending from pharmaceuticals to internet hospitals
Looking only at pharmaceuticals would easily underestimate Keruide's current business portfolio. The company has formed multiple business segments, including pharmaceuticals, medical nutrition foods, medical devices, and internet hospitals.
In terms of pharmaceuticals , the company has core products such as Lukang (tandospirone citrate capsules), Kailaitong (tizanidine hydrochloride tablets), and Kaliwen (bevanolol hydrochloride tablets), covering treatment areas such as anxiety, pain, and cardiovascular diseases.
In the field of medical nutrition foods , two brands have been incubated: Konews (emotional health) and Anheya (cardiovascular metabolic health).
In the field of medical devices , the company possesses diagnostic and treatment equipment such as the Shujie Transcranial Magnetic Stimulator (TMS) and Heart Rate Variability Analysis System (HRV), as well as a menstrual blood detection device.
In terms of service model , Keruide's Keruide Internet Hospital provides internet hospital services based on physical hospitals, remote health management, and internet information services. Through the internet hospital, the company can directly connect with patients, providing online consultation, diagnosis, and prescription services, making up for the shortcomings of traditional pharmaceutical companies in directly reaching patients and bridging the "last mile" from product to patient.
In terms of international production capacity , Kerui Pharmaceutical has established a wholly-owned subsidiary, Kerui Pharmaceutical (Hong Kong) Limited, in the Hong Kong Special Administrative Region. The Hong Kong factory is currently in the equipment installation and commissioning phase. Meanwhile, Kerui Pharmaceutical's API (Active Pharmaceutical Ingredient) production base has obtained FDA certification in the United States, and its products have been exported to the European and American markets for many years.
These strategic moves are not directly equivalent to the approval of dexketoprofen tromethamine tablets, but they demonstrate the company's ambition to gradually expand from drug research and development and sales into medical nutrition, medical device diagnostics, and internet-based healthcare services. For patients, this means they may encounter more than just a single drug in the future; they may receive a variety of services related to disease treatment and health management. Of course, whether these services can be truly implemented depends on actual operation and patient experience.
Source: https://mp.weixin.qq.com/s?__biz=MzYzMzk5NjM0Ng==&mid=2247483996&idx=5&sn=fc4c228c7f001251f2c507560a62322d&chksm=f18b22ca99cd4147eefb0a416ad268c9f19d1e55a3391b24e182fed29c3ad1d209cff3c691db&scene=126&sessionid=0#rd
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