Lunan Pharmaceutical Surges Ahead: Sales of Seven Drug Categories Soar, 15 New Products Approved, with Over 20 Innovative Drugs and 5 First-to-File Generics in Pipeline

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At the beginning of October, Lunan Pharmaceutical Group Corporation successfully launched the significant new product Sacubitril Valsartan Sodium Tablets. A new indication for the Class 1 new drug Recombinant Humanized Anti-BCMA/CD3 Bispecific Antibody for Injection has been approved for clinical trials, further smoothing the group's innovative transformation path. In the first half of 2024, across China’s three major terminals and six key markets (see the end of the article for statistical scope), the sales revenue of seven major drug categories from the group increased by over 10%, yielding impressive results. Since the beginning of this year, Lunan Pharmaceutical Group Corporation has received approval for 15 new products. Currently, 47 high-end generic drugs are under review for production, with the first antibody drug accelerating towards market launch. More than 20 new drugs are actively advancing in clinical trials, showing promising prospects for the future.

15 New Products Harvested This Year, Sales of 7 Major Drug Categories Soared

Lunan Pharmaceutical Group is a comprehensive pharmaceutical group, comprising star pharmaceutical enterprises such as Lunan Houpu Pharmaceutical, Lunan Better Pharmaceutical, and Shandong New Era Pharmaceutical. In recent years, all subsidiaries have been working hard to accelerate the group's transformation.

On October 9, Shandong New Era Pharmaceutical's Sacubitril Valsartan Sodium Tablets were successfully approved. This product is a key variety for hypertension treatment, with sales in China's three major terminals and six major markets exceeding 3.8 billion yuan in 2023, and a growth rate of 38.20% in the first half of 2024. Data from Menet shows that Lunan Pharmaceutical Group Corporation has obtained 15 new products in 2024 so far, surpassing the number from the previous two years.

Table 1: New Products Approved for Lunan Pharmaceutical Group in the Past Three Years

Source: MiNeiNet China Application Progress (MED) Database

In the past three years, all newly approved products of Lunan Pharmaceutical Group Corporation have been Western medicines (chemical drugs + biologics), involving 11 anti-tumor and immunomodulatory agents. Fulvestrant Injection (approved in 2023) is the group's first endocrine therapy drug; seven digestive system and metabolic drugs, with Vonoprazan Fumarate Tablets (approved in 2022) and Sapropterin Hydrochloride Tablets (approved in 2023) being the first generics in China; three each for musculoskeletal system, cardiovascular and cerebrovascular system drugs, and hematological and hematopoietic system drugs; two each for nervous system drugs and miscellaneous categories; and one each for genitourinary system and sex hormone drugs, dermatological drugs, and systemic anti-infective drugs.

Figure 1: The Major Categories of Lunan Pharmaceutical Group in the First Half of 2024

Source: Meneitnet Pattern Database

In China's three major terminals and six major markets, the best-selling traditional Chinese medicines of Lunan Pharmaceutical Group mainly cover 11 major categories, including drugs for cardiovascular and cerebrovascular diseases, digestive system diseases, and pediatric medications. The group’s best-selling Western medicines (chemical drugs + biologics) primarily involve 12 major categories, including drugs for the cardiovascular and cerebrovascular systems, digestive system and metabolism, and musculoskeletal system.

Overall, the sales of 11 major categories showed positive growth in the first half of 2024, with seven categories experiencing growth rates exceeding 10%. The proportion of TCM pediatric medicines was 7.57%, with sales increasing by 48.28%; the proportion of TCM qi and blood tonics was 6.25%, with sales increasing by 18.08%; the proportion of TCM medicines for ENT use was 5.80%, with sales increasing by 23.63%; the proportion of TCM medicines for musculoskeletal system diseases was 0.60%, with sales increasing by 43.26%; the proportion of genitourinary system and sex hormone drugs (chemical + biological) was 0.51%, with sales increasing by 24.27%; the proportion of systemic hormonal preparations (excluding sex hormones and insulin) (chemical + biological) was 0.25%, with sales increasing by 60.27%; the proportion of dermatological drugs (chemical + biological) was 0.16%, with sales increasing by 405.67%.

The First Antibody Drug Aims at a 5 Billion Product, with More Than 20 New Drugs Ready to Launch

On October 10, a new Class 1 drug, recombinant humanized anti-BCMA/CD3 bispecific antibody for injection, received clinical approval for its new indication of "combination with different dosing regimens for the treatment of relapsed or refractory multiple myeloma," further enriching the new drug portfolio of Lunan Pharmaceutical Group.

Figure 2: New drugs applied for by Lunan Pharmaceutical Group Corporation this year

Source: Menei Network China Application Progress (MED) Database

Lunan Pharmaceutical Group Corporation has submitted applications for 10 new drugs since 2024, among which the application for Rituximab Injection is for market launch. If this product is successfully approved, it is expected to become the group's first antibody drug. In 2023, in China’s three major terminals and six major markets, the sales scale of Rituximab Injection exceeded 5 billion yuan. In recent years, domestically produced brands have successively entered the market, continuously encroaching on the market share of the original drug. By the first half of 2024, Roche's market share had fallen to around 32%.

The monoclonal antibody injection LNF2008 and the bispecific antibody injection LNF2007, both classified as Class 1 new drugs, as well as the compound cetylpyridinium iodine lozenges, LN2227, and XZ126 (Class 2 new drugs), and the insulin degludec injection and semaglutide injection (Class 3.3 new drugs) were all submitted for clinical trials for the first time and received approval.

Table 2: Major new drugs currently in clinical trials by Lunan Pharmaceutical Group

Note: Terminated projects are not included in the statistics.

Source: MiNeiNet China Clinical Trial Database

Lunan Pharmaceutical Group's innovative drug R&D layout covers chemical drugs, biologics, and traditional Chinese medicine. More than 20 new drugs have been approved for clinical trials, among which 13 new drugs are in the advanced stages of clinical progress, with promising prospects for market launch.

In terms of Class 1 new biologics, the Phase II/III clinical trial for advanced, persistent, recurrent/metastatic cervical cancer with Lonaratumab Injection was initiated in July this year. The Phase II clinical trial for advanced (Stage IVb), persistent, recurrent, or metastatic cervical cancer with Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection was completed in January this year. LNF1802 Monoclonal Antibody Injection, which received clinical approval in November 2023, as well as Recombinant Leukocyte Inhibition Factor and Hirudin Peptide Chimeric Protein for Injection and LNF2008 Monoclonal Antibody Injection, which received clinical approval in January and April 2024 respectively, have successively entered Phase I clinical trials this year.

The Phase II clinical trial for postoperative gastrointestinal dysfunction of Mosapride Citrate Injection, a Class 2 new chemical drug, was initiated in August this year. Icaritin Capsules, a Class 2 new traditional Chinese medicine, received clinical approval in March 2023 and launched its Phase I clinical trial for primary immune thrombocytopenia in May 2024.

47 High-End Generic Drugs Racing Forward, 77 Products Already Approved

With the united efforts of its subsidiaries, Lunan Pharmaceutical Group's product portfolio is becoming increasingly enriched. From 2022 to present, the group has 47 high-end generic drugs under review for production, covering 11 major categories (22 subcategories).

Table 3: Lunan Pharmaceutical Group Corporation's Generic Drug New Products Under Review for Production

Source: MiNeiNet China Application Progress (MED) Database

Lunan Pharmaceutical Group is expected to achieve new breakthroughs in four major market categories: Prucalopride Succinate Tablets may become the group's first chemical drug for treating constipation, Calcitriol Soft Capsules may become the group’s first vitamin-based drug, Nalfurafine Hydrochloride Orally Disintegrating Tablets may become the group’s first anti-itch medication, and Roxadustat Capsules may become the group’s first anti-anemia preparation.

It is worth noting that Bilastine Tablets, Nalfurafine Hydrochloride Orally Disintegrating Tablets, Bilastine Orally Disintegrating Tablets, Ruxolitinib Phosphate Tablets, and Brexpiprazole Orally Disintegrating Tablets currently have no domestically approved products in China. Lunan Pharmaceutical Group will participate in the race for the first domestic generic versions of these five products, with the potential to add several重磅 products to the group's first-to-market generics portfolio.

Table 4: Market Situation of Lunan Pharmaceutical Group's Products that Have Won Bids in National Procurement

Source: Terminal Competition Pattern of Pharmaceutical Products in China's Public Medical Institutions (MiNe Network)

Lunan Pharmaceutical Group actively participates in the national centralized bulk procurement. From the third to the ninth batch of national procurement (excluding the insulin special project), it has won bids for 16 products. In the first half of 2024, in the terminals of China's public medical institutions (urban public hospitals + county public hospitals + urban community centers + township health centers), the group has become the leading enterprise in mosapride citrate tablets, milrinone injection, and isosorbide mononitrate tablets, and the TOP2 enterprise in cetirizine hydrochloride tablets, isosorbide mononitrate sustained-release tablets, tirofiban hydrochloride sodium chloride injection/tirofiban hydrochloride concentrated solution for injection, argatroban injection, ketorolac tromethamine injection, amoxicillin clavulanate potassium tablets, and omeprazole sodium bicarbonate capsules (Ⅱ).

Table 5: Products with ≥5 Competing Companies

Note: Sales below 100 million yuan are indicated with *

Source: Terminal Competition Pattern of Pharmaceutical Products in China's Public Medical Institutions (MiNe Network)

In terms of consistency evaluation, as of October 16, 2024, Lunan Pharmaceutical Group has successfully evaluated (including deemed successful evaluations) 77 products (counted by product name + company name). Currently, among the group's successfully evaluated products that have not yet been included in national procurement, there are 10 products with competition from ≥5 companies (original research + successfully evaluated).

Recently, there is news that the tenth round of national procurement in China will start on October 18th. The leaked directory includes Sugammadex Sodium Injection and Isosorbide Dinitrate Injection. To date, the number of competing companies (original research + generic) for Sugammadex Sodium Injection exceeds 20, while for Isosorbide Dinitrate Injection, it exceeds 10. Both of these injectable products from Lunan Pharmaceutical Group Corporation were newly approved in 2024. Although the tenth round of national procurement in China is late, we are waiting to see if Lunan Pharmaceutical Group Corporation can achieve good results.

Source: MNI Database, Company Official Website, etc.

Note: The drug competition pattern of the three major terminals and six markets in China by Menet, the statistical scope includes: urban public hospitals and county public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies. It excludes private hospitals, private clinics, village clinics, and pharmacies in counties, villages, and towns. The sales mentioned above are calculated based on the average retail price of products at the terminal. Data statistics are as of October 16th. If there are any omissions, your corrections are welcome!