Lunan Pharmaceutical Surges with 11 Exclusive TCMs, 32 New Drug Approvals, 3 First-in-Class Generics, and 18 Pipeline Candidates

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Recently, XZ157 from Shandong New Era Pharmaceutical has been approved for clinical trials, and Dronedarone Hydrochloride Tablets have been approved for marketing. Lunan Pharmaceutical Group’s portfolio of new drugs and generic drugs has gained new momentum. In 2024, Lunan Pharmaceutical Group is making a comprehensive breakthrough: sales of 11 exclusive traditional Chinese medicines (TCMs) have surged, the group's biologics exceeded 100 million yuan in revenue while maintaining rapid growth, and 26 new chemical drug products have been approved. Since 2025, the group has added six new chemical drug products to its portfolio, with three first-to-market generics and its first antibody drug on track for market launch. Eighteen new drugs (a combination of TCMs, biologics, and chemical drugs) are accelerating through clinical trials. The group is now entering a high-speed phase of innovative transformation.

Chinese patent medicines continue to boom, 22 exclusive products shine brightly

Lunan Pharmaceutical Group is a comprehensive pharmaceutical group that integrates the production, research, and sales of traditional Chinese medicine, chemical medicine, and biologics. Its member enterprises include star pharmaceutical companies such as Lunan Houpu Pharmaceutical, Lunan Better Pharmaceutical, and Shandong New Era Pharmaceutical.MENET DataIt shows that Lunan Pharmaceutical Group Corporation currently has over 270 formulated products on the market, of which traditional Chinese medicine accounts for about 30%.

Figure 1: Sales of Traditional Chinese Medicine Products by Lunan Pharmaceutical Group in China's Three Major Terminals and Six Markets (Unit: Ten Thousand Yuan)

In China's three major terminals and six major markets (the statistical scope is at the end of the article), the traditional Chinese medicine of Lunan Pharmaceutical Group has maintained a steady growth trend in the past five years, breaking through 4 billion yuan in 2023, with a growth rate of over 11% in the first half of 2024.

After years of efforts, Lunan Pharmaceutical Group Corporation's traditional Chinese medicine has successfully entered the TOP10 group (Level 1, hereinafter the same) in 10 sub-class markets within China's three major terminals and six major markets. In the first half of 2024, the Group ranked as the TOP2 group in three sub-class markets: pediatric cough and phlegm medication, rhinitis medication, and constipation medication. It ranked as the TOP4 group in diabetes medication, the TOP5 group in hemorrhoid medication, the TOP6 group in blood tonic medication, the TOP7 group in two sub-class markets: cold medication and vertigo medication, the TOP9 group in hemostatic medication, and the TOP10 group in cardiovascular disease medication.

Table 1: Lunan Pharmaceutical Group's Exclusive Traditional Chinese Medicines

Lunan Pharmaceutical Group has 22 exclusive proprietary Chinese medicines distributed across 16 sub-class markets. Among them, 11 products achieved positive sales growth in the first half of 2024 in China's three major terminals and six key markets. Notably, Xiao'er Xiaoji Zhike Oral Liquid, Chuanzhi Tongluo Capsules, Guiqi Huoxue Capsules, and Mailuo Shutong Granules saw sales surge by over 40%, delivering outstanding results.

In February 2025, Lunan Houpu Pharmaceutical's TCM Class 1.1 new drug, Chuanhu Qutong Granules, applied for clinical trials, adding another significant member to the group's TCM new drug portfolio. The new drug is intended for the treatment of acute gouty arthritis and other conditions.

Table 2: Status of Some Key Traditional Chinese Medicine New Drugs Under Development by Lunan Pharmaceutical Group

Lunan Pharmaceutical's Zhigen Tou Tong An Capsules were first submitted for clinical trials in 2008, and this March, the new drug initiated Phase III clinical trials for the migraine indication. The group currently has several approved traditional Chinese medicine (TCM) products in the market for neurological disorders: calming and brain-nourishing drugs (Yangxue Anshen Tablets, Anshen Bunao Liquid, Ningshen Buxin Tablets) and vertigo treatments (Tianma Xuan Yun Ning Granules). Zhigen Tou Tong An Capsules will help the group expand into the TCM headache medication (migraine) market.

Biological drugs have broken through 100 million yuan, and the first antibody drug is expected to be launched.

In recent years, the biopharmaceutical market in China has developed rapidly, gradually moving from "keeping up with others" to "leading the way." In 2021, Lunan Pharmaceutical Group entered the biopharmaceutical market, and its first product, Pegylated Human Granulocyte Stimulating Factor Injection, was successfully approved. By 2023, the sales revenue of this product in China's three major terminals and six key markets had exceeded 100 million yuan, with a growth rate of 22.86% in the first half of 2024. In 2022, the group obtained Insulin Glargine Injection, marking its first insulin and insulin analog product.

Figure 2: Sales of biopharmaceuticals by Lunan Pharmaceutical Group Corporation in China's three major terminals and six major markets (Unit: ten thousand yuan)

Table 3: Overview of Some Key Biologic Drugs Under Development by Lunan Pharmaceutical Group

Lunan Pharmaceutical Group's Rituximab Injection has been submitted for production approval and is currently under review. If successfully approved, it will become the group's first marketed antibody drug. In 2023, the sales revenue of Rituximab Injection in China's three major terminals and six major markets exceeded 5 billion yuan.

In addition, the group is actively advancing the clinical trials of several Class 1 new biologic drugs. The Phase II clinical trial for the indication of relapsed or refractory multiple myeloma using a recombinant humanized anti-BCMA/CD3 bispecific antibody injection was initiated in March this year. The Phase I clinical trial for acute ischemic stroke using a recombinant leukocyte inhibitory factor and hirudin chimeric protein injection was completed in January this year. The Phase I clinical trial for recurrent or refractory B-cell malignancies using LNF1904 and the Phase I clinical trial for advanced solid tumors using LNF2007 bispecific antibody injection were both launched in January this year...

32 New Chemical Drug Products Approved, 3 First Generic Drugs Accelerate to Market

In recent years, under the叠加影响of multiple policies, the chemical drug market has experienced ups and downs, while the demand of the Chinese people for high-quality drugs continues to increase. In 2024, Lunan Pharmaceutical Group Corporation obtained 26 new chemical drug products. Recently, the subsidiary Shandong New Time Pharmaceutical's Dronedarone Hydrochloride Tablets were approved, becoming the group's sixth new chemical drug product in 2025. All of the aforementioned products are high-end generic drugs that have been approved according to new classifications and are considered to have passed the consistency evaluation.

Table 4: New chemical drug approvals for Lunan Pharmaceutical Group Corporation from 2024 to present

Notably, Prucalopride Succinate Tablets are the first approved medication for treating constipation by Lunan Pharmaceutical Group, with the market size for constipation-treating chemical drugs in China’s three major terminals and six key markets reaching 6 billion yuan in 2023. Additionally, Minoxidil Solution is the group's first drug in the category of other dermatological treatments, and Sugammadex Sodium Injection is its first product in the category of all other therapeutic medications. Lunan Pharmaceutical Group has achieved new breakthroughs in these three sub-markets.

Table 5: New chemical drug products currently under review by Lunan Pharmaceutical Group

Currently, Lunan Pharmaceutical Group Corporation has 34 high-end generic drugs under review for production. Among them, only the original research company of Narufurafurin Hydrochloride Orally Disintegrating Tablets has been approved for import, while Brexpiprazole Orally Disintegrating Tablets and Bilastine Orally Disintegrating Tablets have not yet been marketed in China (original research/domestically produced). The group will participate in the competition for the first domestic generic versions of these three products.

In terms of exploring new markets, Calcitriol Soft Capsules are expected to become the group's first vitamin-based drug, Roxadustat Capsules are anticipated to be the group’s first anti-anemia preparation, and Topiramate Tablets are likely to become the group’s first anti-epileptic medication. The group is gradually expanding its product line.

Table 6: Status of Some Key Chemical New Drugs Under Development by Lunan Pharmaceutical Group

Since the beginning of this year, LNH2116-X1, a Category 2.2 new chemical drug developed by Lunan Better Pharmaceutical, and XZ157, a Category 2.2 new chemical drug from Shandong New Era Pharmaceutical, have been approved for clinical trials, further strengthening Lunan Pharmaceutical Group's portfolio of new chemical drugs.

Currently, Lunan Group has four chemical new drugs with relatively fast clinical progress, among which the Phase II clinical trial for the indication of peptic ulcer bleeding using Fumaric Acid Vonoprazan Injection was initiated in January this year.

Conclusion

Lunan Pharmaceutical Group, as a comprehensive pharmaceutical group, is making strides in three major fields: traditional Chinese medicine, biopharmaceuticals, and chemical drugs. Each year, not only are new products approved, but the group also actively expands its new drug pipeline. As research and development achievements continue to emerge, the group's competitiveness will keep increasing.