Immunosuppressant Blockbusters Spark New Wave of Generic Competition; Local Companies Rush to Enter Market Amidst Continuous Approvals; Intense Rivalry in Multi-Billion-Dollar Key Sector Heats Up!

Recently, according to the information disclosed on the official website of the National Medical Products Administration,Qilu PharmaceuticalSubmittedCategory 4 Generic DrugsCyclosporine Soft CapsulesApproved and deemed to have passed the consistency evaluation. This time, Qilu Pharmaceutical's successful approval has become the fifth generic drug company in China for this variety.

Notably, as a significant large variety, cyclosporine soft capsules have already been successfully replicated by four companies: North China Pharmaceutical, Jiangsu Xinfu Pharmaceutical, Livzon Pharmaceutical, and Hangzhou Zhongmei Huadong Pharmaceutical. This time, Qilu Pharmaceutical becoming the fifth company to pass the evaluation will further expand its pipeline layout in the field of immunosuppressant drugs.WithIn the future, with the increase in the number of varieties passing the consistency evaluation, the competitive landscape for immunosuppressants will also enter a more intense phase.

Local Giant Makes a Strong Entry

New Member Added to the Field of Immunology

In recent years, with the increase in organ transplant surgeries and the number of patients with autoimmune diseases, the clinical demand for immunosuppressive drugs has shown a growing trend. Immunosuppressants refer to any drugs that can reduce the body's immune response. These drugs typically target a specific point of humoral or cell-mediated immune responses and can be used to treat primary or secondary immune-mediated diseases. In primary diseases, immunosuppressants are used to modulate the body's own immune response, thereby inhibiting the proliferation and function of cells associated with the immune response and reducing immune responses. When determining the cause of secondary immune-mediated diseases, the initial treatment should be to stop the triggering factors or treat the underlying disease.

Cyclosporine, a commonly used immunosuppressant in clinical practice, is primarily utilized to prevent and treat graft-versus-host reactions that occur during bone marrow transplantation. It is also suitable for preventing rejection reactions in allogeneic kidney, liver, heart, bone, and other organ or tissue transplants. Additionally, it is widely used in clinical settings for endogenous uveitis, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome.

Cyclosporine Molecular Structure Diagram

From a pharmacological perspective, compared with other immunosuppressants, cyclosporine can prolong the survival time of allogeneic organ (skin, heart, kidney, pancreas, bone marrow, small intestine, and lung) transplants; it inhibits the synthesis and release of lymphokines (including IL-2) and blocks the G0 and early G1 phases of the lymphocyte growth cycle; it does not suppress erythropoiesis nor affect phagocyte function; patients using cyclosporine have a lower incidence of infection compared to those using other immunosuppressants.

It is reported that the cyclosporine soft capsules approved this time by Qilu Pharmaceutical are a self-microemulsifying formulation with advanced and stable production technology. They address various issues such as the susceptibility of the contents to oxidation and unstable capsule dissolution, and also feature child-resistant functionality. Previously, Qilu Pharmaceutical initiated the development of cyclosporine soft capsules in 2021, adopting a synchronized registration submission strategy in both China and the U.S. Production was submitted in October 2023, and in 2024, it successfully passed on-site inspections by China's NMPA and the U.S. FDA.

It is reported that soft capsules, as a new type of oral formulation, have the advantages of masking the unpleasant odor of drugs, improving drug stability, and solidifying liquid drugs for convenient administration. Additionally, they exhibit high bioavailability, accurate content, and good uniformity, often serving as an effective delivery system for irritant drugs, oily drugs, easily oxidized drugs, volatile drugs, and hydrophobic drugs. Notably, the cyclosporine soft capsule recently approved by Qilu Pharmaceutical Co., Ltd. is not only the fifth company in China to succeed in the cyclosporine soft capsule generic competition but also the sixth soft capsule formulation in Qilu Pharmaceutical's self-developed pipeline to be approved for marketing.

Since 2025, Qilu Pharmaceutical has continued to make significant progress in the generic drug sector, with a wide range of developments involving anti-tumor, hematological tumor, and anti-HIV drugs. The approval of multiple first-to-market generic drugs has further solidified its leading position in China's generic drug market and significantly impacted the landscape of the original drug market.

In the field of anti-tumor drugs, Qilu Pharmaceutical's Ibrutinib Tablets (BTK inhibitor) was approved for marketing in January 2025, becoming the first generic drug of this formulation in China and breaking the monopoly of the original drug Imbruvica (Johnson & Johnson/AbbVie) in the Chinese market. In 2023, global sales of Ibrutinib exceeded $6.8 billion, with the domestic market also showing continuous growth. The launch of Qilu’s generic version not only reduced medication costs for patients but also provided a competitive benchmark for subsequent generic drug companies (such as Shuanglu Pharmaceutical and Huadong Medicine) to strategize their positioning.

In the field of hematological tumors, Qilu Pharmaceutical's Citrate Ixazomib Capsules (proteasome inhibitor)Qilu Pharmaceutical's generic version is expected to be the first approved in February 2025, filling the gap for this formulation in China. The original drug was developed by Takeda Pharmaceutical and is mainly used for the treatment of multiple myeloma, with significant market potential in China. After the launch of Qilu’s generic version, it is expected to further divide the market share of the original drug and drive prices down.

Moreover, in the field of anti-AIDS, Qilu Pharmaceutical's Entecavir and Rilpivirine Tablets (a triple combination drug) was approved in July 2024 as the first domestically produced generic drug in China, seizing the opportunity before the original drug Odefsey (Gilead) entered the Chinese market. With global sales of the original drug reaching $1.35 billion in 2023, the launch of this generic version not only improves drug accessibility but also optimizes patient compliance through its single-tablet combination design, injecting new vitality into China's domestically produced anti-HIV drug market.

As of the time of writing, this year has seenSix drugs (including subsidiaries) have been approved and are considered to have passed the evaluation (see the summary in the figure below). Among them,Ixazomib Citrate CapsulesAndIbrutinib TabletsThe first variety to pass the evaluation.In addition, Qilu Pharmaceutical has amoxicillin sodium clavulanate potassium for injection, nusinersen sodium injection, maribavir tablets, melphalan hydrochloride for injection, fluticasone furoate nasal spray, and etofenamate patch.Six varieties have submitted marketing or clinical applications under the new registration classification. It is reported that none of the above six varieties have received their first generic approval in China, and Qilu Pharmaceutical is expected to secure the first generic approvals and pass evaluations for multiple drugs in the future.

[Summary of Qilu Pharmaceutical's Generic Drugs Approved in 2025]

Industry analysts believe that Qilu Pharmaceutical's strategic layout demonstrates its precise grasp of the expiration window for high-value original drug patents, especially in the treatment areas of hematological tumors, multiple myeloma, and AIDS. In the future, as many core original drug patents are set to expire in the coming years, Qilu is expected to further expand its market share, promoting the formation of a competitive landscape in China’s generic drug market characterized by a "three-pillar" structure of original drugs, innovative drugs, and generics.

Rise of Local Pharmaceutical Companies

Original Research Novartis May Face Siege

The original research drug Cyclosporine was developed by Swiss pharmaceutical company Novartis. It was first launched in Germany in 1994 under the brand name "Sandimmune Neoral," and later received FDA approval in the United States in July 1995. In the Chinese market, Novartis' Cyclosporine soft capsules were approved for marketing in 1996. Its indications include prevention of organ transplant rejection and graft-versus-host disease (GVHD) in bone marrow transplantation, as well as treatment of autoimmune diseases such as endogenous uveitis, psoriasis, atopic dermatitis, rheumatoid arthritis, and nephrotic syndrome.

In response to the import pressure brought by Novartis' original drug entering the Chinese market, many domestic companies have already ventured into generic production. As early as 1996, Zhongmei Huadong was the first company in China to launch a domestically produced generic version. In January 2019, Hangzhou Zhongmei Huadong Pharmaceutical (referred to as Huadong Pharmaceutical or Zhongmei Huadong), a wholly-owned subsidiary of Huadong Medicine Co., Ltd., received the "Drug Supplemental Application Approval" issued by the NMPA. The cyclosporine soft capsules (50mg, 25mg) produced by Zhongmei Huadong passed the consistency evaluation, making it the first company to achieve this milestone. Since the approval of its generic version, Zhongmei Huadong’s market share has gradually increased, progressively encroaching on Novartis' original drug market share. By 2016, it successfully surpassed Novartis to become the largest enterprise in the domestic market.

Huadong Medicine stated that immunological products are a distinctive and highly competitive product line for the company. The three main products in the field of immunological disease drugs—cyclosporine, mycophenolate mofetil, and tacrolimus—are all first-line clinical medications, often used in combination therapy. Notably, cyclosporine was included in the 2012 and 2018 editions of the National Essential Medicines List, while the 2017 National Reimbursement Drug List removed usage restrictions on indications for cyclosporine soft capsules. As a National Essential Medicine and a drug covered by national insurance, Huadong Medicine’s cyclosporine soft capsules were the first to pass the generic drug consistency evaluation in China. This will enhance the cost-effectiveness of the product, further promoting its import substitution, consolidating and expanding its market share.

In November 2019, North China Pharmaceutical Co., Ltd. (Abbreviation: North China Pharmaceutical) officially received the approval document from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The two specifications of Cyclosporine Soft Capsules (25mg\50mg) passed the quality and efficacy consistency evaluation for generic drugs, indicating that the Cyclosporine Soft Capsules have reached the same level of quality and efficacy as the original research drug. Meanwhile, North China Pharmaceutical became the second company to pass the generic Cyclosporine Soft Capsules evaluation after Huadong Medicine.

It is reported that Cyclosporine Soft Capsules are one of the key products developed by North China Pharmaceutical Co., Ltd. and also a significant product in the company’s full immunosuppressant industry chain. Since its launch, the product has been widely recognized by medical experts and patients for its quality and efficacy. In recent years, the product's market sales have continued to increase, ranking third in sales in the Chinese market. Apart from Cyclosporine Soft Capsules, the North China Pharmaceutical immunosuppressant family also includes different drugs such as Sirolimus, Mycophenolate Mofetil, and Mizoribine, bringing good news to a wide range of organ transplant patients and those suffering from rare diseases.

In March 2023, the NMPA released the latest batch of drug approval certificates delivery information. Livzon Group's Cyclosporine Soft Capsules passed the consistency evaluation, becoming the third company to pass the evaluation for this product.

In June 2024, Xinfu Pharmaceutical successfully completed the first production of cyclosporine soft capsules after passing the consistency evaluation, and the product will be fully launched in the Chinese market. According to Xinfu Pharmaceutical's press release, this production marks the first batch of cyclosporine soft capsules manufactured after passing the evaluation.The product packaging also features a new design style and includes a consistency evaluation logo. Meanwhile, Xinfu Pharmaceutical is the fourth company in China to have its generic version of this drug pass the evaluation.  

Xinyu Pharmaceutical's Cyclosporine Soft Capsules are a self-microemulsifying formulation. The consistency evaluation approval was granted based on the unaltered prescription and manufacturing process of an already marketed product. It is also the only cyclosporine soft capsule product in China that has been continuously produced using the same approved prescription and process for many years. The approved shelf life of this product is 36 months, making it the only cyclosporine soft capsule product with consistency evaluation approval that has been directly granted a validity period exceeding 24 months.

As a significant variety, Cyclosporine Soft Capsules have shown a favorable development trend in the Chinese market since their launch. According to data from Menet, in 2017, the terminal sales of Cyclosporine Capsules in Chinese urban public hospitals, county public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) reached 1.361 billion yuan, with a year-on-year increase of 10.79%. The market share of Cyclosporine Soft Capsules produced by Zhongmei Huadong in the Chinese Cyclosporine formulation market exceeds 45%, surpassing the market share of the original research drug.

Currently, generic drug companies are accelerating their dominance in the market through price advantages, localized channels, and support from medical insurance policies. In recent years, the competitive landscape of China's cyclosporine soft capsule market has shown a rapid rise of generics, squeezing the share of original research companies. Although original research companies once occupied the high-end market for a long time due to brand and technical advantages, domestic generic drug companies have gradually broken the monopoly by speeding up the consistency evaluation process.

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