China’s TCM Stuns with 50 Exclusive Formulas, 48 Class I Innovative Drugs in Pipeline, 11 New Launches Imminent

Source: Dengyuemed | September 5, 2025 | Category: Pharmaceuticals

As a Hong Kong Drug Wholesale Distributor, we maintain an open attitude of learning, keeping a close eye on the progress and achievements of new TCM approvals in China.

Recently, China’s traditional Chinese medicine (TCM) industry, known for exclusive formulas, announced H1 2025 results.

During the reporting period, the traditional Chinese medicine industry achieved operating revenue of RMB 1.642 billion, net profit attributable to shareholders of RMB 142 million, and net operating cash flow of RMB 144 million.

By the end of the reporting period, the TCM industry held 214 drug manufacturing approvals, including 50 exclusive formulas. China’s TCM enterprise adheres to innovation-driven development, currently with 33 exclusive formulas/new drugs under research, of which 11 are in NDA/Pre-NDA/Phase III clinical stages, expected to be launched soon.

In addition, 19 Class I innovative chemical drugs and biopharmaceuticals are in development, and 8 generic drugs are targeting a market worth RMB 4 billion.

Holding 50 Exclusive Formulas! Continuous Progress in New Drug R&D

China’s traditional Chinese medicine (TCM) industry, currently holding 214 drug manufacturing approvals (147 TCM, 61 chemical drugs, and 6 active pharmaceutical ingredients), among which 50 are exclusive formula products.

Its product line mainly focuses on TCM strengths in respiratory and infectious diseases, cardiovascular and cerebrovascular diseases, gynecology, and orthopedics, covering dosage forms including oral liquids, injections, capsules, tablets/pills, granules/powders, patches, and gels.

On August 28, China announced its H1 2025 financial results, achieving operating revenue of RMB 1.642 billion, net profit attributable to shareholders of RMB 142 million, and net operating cash flow of RMB 144 million.

The traditional Chinese medicine industry noted that due to a complex external environment, pharmaceutical industry policies, and fluctuating terminal market demand for respiratory and cardiovascular drugs.

Nevertheless, the TCM industry continues to strengthen internal governance and deepen marketing, academic leadership, and compliance.

From a product-wise perspective, during H1 2025, revenues from injections, oral liquids, and granules/powders declined, while tablets/pills and gels performed well, achieving double-digit year-on-year growth.

H1 2025 Product Revenue Breakdown (RMB Billion)

Despite temporary pressure, China remains committed to innovation-driven development, focusing on TCM while actively expanding chemical and biopharmaceutical R&D.

Since the beginning of the year, the TCM industry has been advancing the development of TCM new drugs, chemical new drugs, biopharmaceuticals, and chemical generics.

TCM New Drugs:

• Class 1.1 new drugs Canpu Granules and Class 3.1 new drug Yunu Decoction Granules have been approved for marketing, offering new treatment options for patients with sequelae of pelvic inflammatory disease and stomach-heat Yin-deficiency syndrome, respectively.
• Class 1.1 new drug Liuwei Dihuang Glycoside Tablets and Class 3.1 new drugs Xiebai Granules and Yiguan Decoction Granules have submitted NDAs for menopausal syndrome (Kidney Yin deficiency), pediatric lung-heat cough/asthma, and liver Yin deficiency/blood-dry Qi-stagnation syndrome, respectively.
• Class 1.1 new drug Maxing ZhiXiao Granules has entered Phase III clinical trials for bronchial asthma.
• Solid Ben Xiaozhen Granules (chronic urticaria), Lianshen Menopause Granules (menopausal syndrome), and Jianpi Shugan Guben Granules (diarrhea-predominant irritable bowel syndrome) have been approved for clinical trials.

Class I Innovative Chemical Drugs:

• Flunopirzine Tablets (Alzheimer’s disease) completed Phase II clinical data analysis.
• Wnt inhibitor KY0135 Tablets and EGFR/HER2 dual inhibitor KY1702 Capsules started Phase I clinical trials, both as anti-tumor drugs.
• CCR8-specific inhibitor KYS2301 Gel submitted an IND and was approved for clinical trials to treat atopic dermatitis.

Class I Biopharmaceuticals:

• NGFR agonist recombinant human nerve growth factor eye drops, GLP-1R/GIPR dual agonist ZX2010 injection, and GLP-1R/GIPR/GCGR triple agonist ZX2021 injection have entered Phase II clinical trials.

Generic Drugs:

• Two drugs obtained registration certificates: Sitagliptin/Metformin Tablets (II) and Shumapetan Naproxen Sodium Tablets, with the latter being the first domestic approval.
• One product, Telmisartan Capsules, passed bioequivalence evaluation.
• Ezetimibe/Atorvastatin Tablets (I), Brexpiprazole Tablets, and Ligliptin Tablets were submitted under new registration classifications.

29 Class I TCM New Drugs in Development, 11 Expected to Launch Soon

China has maintained a steady stream of TCM new drug approvals each year since 2020, including Jingu Zhitong Gel (2020), Yinqiao Qingre Tablets (2021), Sanchan Huashi Granules & Lingui Shugan Granules (2022), Jichuan Decoction Granules (2023), Wenyang Jiedu Granules (2024), and Yunu Decoction & Canpu Granules (2025).

Since 2021, at least one Class I TCM new drug has been approved for clinical trials annually, covering respiratory, gynecology, pediatrics, and other areas.

This has created a virtuous cycle of “one batch marketed, one batch in clinical trials, one batch under development,” expanding the depth and breadth of Class 1.1 TCM new drugs.

Currently, 33 TCM new drugs are under clinical or higher-stage development in China, covering respiratory, gynecology, pediatrics, digestive/metabolic, and cardiovascular areas.

According to the new TCM registration management rules, 29 are Class I innovative TCM drugs, 2 are Class II improved new drugs, and 2 are classical prescription compound formulations.

Class I TCM New Drugs in Domestic Development

• Longqi Capsules, Liuwei Dihuang Glycoside Tablets (Class 1.1), and Xiebai Granules, Yiguan Decoction Granules (Class 3.1) submitted NDAs in 2024–2025, expected to bring approval news this year or next. Longqi Capsules, with phlegm-resolving and lung-clearing effects, could become the first approved TCM innovation for lung cancer in China.
• Seven TCM new drugs are in Pre-NDA or Phase III clinical trials, mainly for respiratory diseases such as Shuangyu Granules (influenza), Zixin Biqiu Granules (rhinitis), Redoxin Granules (influenza), and Maxing ZhiXiao Granules (asthma).
• Twelve Class I TCM new drugs are in Phase II clinical trials for gynecology, respiratory, cardiovascular, and pediatric indications.

Besides vertical development of new TCM drugs, China is also expanding indications and conducting evidence-based research for already marketed products.

Examples include Dazhu Hongjingtian Capsules (prevention of acute altitude sickness, Phase III), Jinzhen Oral Liquid (children’s viral pneumonia, Phase II), Congrong Total Saponins Capsules (Alzheimer’s disease, Phase II), and Xingbei Cough-Relief Granules (post-infection cough, Phase II).

19 Class I Chemical and Biopharmaceutical Drugs Targeting a RMB 230 Billion Market

Alongside innovation in TCM, China is accelerating chemical and biopharmaceutical R&D, entering a high-growth phase since 2023.

Currently, 19 Class I chemical/biopharmaceutical drugs are under clinical or higher-stage development domestically, focusing on oncology, autoimmune, cardiovascular, metabolic, and ophthalmology indications.

• Nine Class I drugs are in Phase II trials, including ZX2021 injection, a GLP-1R/GIPR/GCGR triple agonist with no approved domestic equivalent, ranking in the first R&D tier.
• Eight Class I drugs are in Phase I trials, including KYS202004A injection, a dual-target Fc fusion protein blocking TNF-α and IL-17A for psoriasis, and KY0135 tablets, a Wnt pathway inhibitor, both with no domestic approved equivalents.

For generics, 8 products are under review via new classification filings, collectively targeting RMB 4 billion in 2024 sales, including blockbusters like Empagliflozin and Ligliptin Tablets.

Two of these products, Brexpiprazole Tablets and Sodium Cromoglycate Inhalation Solution, have no first-generic approval yet.

In Hong Kong Deng Yue Medicine, we take these successful cases as valuable references to further enhance our professional knowledge and service capabilities, better supporting patients and partners.