Domestic Generics Challenge Johnson & Johnson's Selexipag Dominance as Hansoh and Zhuyangxin Secure Simultaneous First-to-File Approval in China

Dec 19, 2024 20:54 CST Updated 20:54

Johnson & Johnson

Medical Device R&D and Manufacturer

In the Chinese market, once the first generic version of a major imported drug is approved，“Patent Cliff”The effect will greatly intensify the market.Competition，A fierce price war will also be inevitable.

Recently, information from the National Medical Products Administration's government service portal showed that Jiangsu Hengrui Medicine Co., Ltd. and Hangzhou Zhuyangxin Pharmaceutical Co., Ltd. received approval for the production of Selexipag tablets on the same day, ranking as the first generic version in China to be approved and the first to pass the evaluation.

Notably, Selexipag, the original imported drug developed by Actelion, is a prostacyclin I2 (PGI2) receptor agonist that was first approved for marketing in the United States in December 2015 under the trade name "UPTRAVI." It is used to treat pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of PAH-related hospitalization. In 2017, Actelion was acquired by Johnson & Johnson, and Selexipag became a key product of Janssen Pharmaceuticals under Johnson & Johnson. Today, the successful generic production by Jiangsu Hansoh and Hangzhou Zhuyangxin Pharmaceutical Co., Ltd. provides new options for clinical use and effectively breaks the monopoly of the original drug in the Chinese market.

Industry insiders believe that the approval and market entry of domestically produced generic drugs has kicked off a competition with original research drugs. The original research drug Selexipag previously held a significant market share, with rapid sales growth since its launch. The arrival of these generics is bound to compete for a place in the pulmonary arterial hypertension drug market. In China, other companies such as Hunan Fangsheng Pharmaceutical and Chongqing Sunva Pharmaceuticals have also submitted their applications for market entry, and will further challenge imported products in the future.

Heavyweight Product Welcomes First Generic

The original research barriers are being broken down.

Pulmonary HypertensionIt is a pathophysiological condition characterized by an abnormal increase in pulmonary artery pressure, often leading to various complications such as hypoxia-induced dyspnea, respiratory insufficiency, cyanosis, and right atrial dysfunction-induced cirrhosis, atrial fibrillation, edema, etc.RelevantStudies show that the average survival period of patients with untreated pulmonary arterial hypertension is only2.8 years, so the disease is also known as "the cancer of cardiovascular diseases."

Current Treatment for Pulmonary Arterial Hypertension Shows Diversified Characteristics

Selexipag is a prostacyclin receptor agonist that can be used to treat pulmonary arterial hypertension. The drug mainly works by activating the IP receptor (G protein-coupled receptor) on the surface of pulmonary vascular smooth muscle cells, activating adenylate cyclase and triggering a series of reactions, thereby inhibiting the contraction and proliferation of pulmonary artery smooth muscle cells to reduce MPAP and pulmonary vascular resistance.

As an important product in the rare disease market, selexipag tablets were included in the priority review process as a clinically urgently needed variety to expedite evaluation and approval. In November 2018, Johnson & Johnson's original selexipag tablets were approved for marketing in China under the trade name "Uptravi." In 2019, they were successfully included in the medical insurance directory through negotiations, drawing market attention, and were smoothly renewed during the medical insurance negotiations in 2021 and 2023.

The Jiangsu Hansoh generic version of Selexipag, which has been recently approved, officially submitted a Class 4 generic drug marketing application in June 2021. At that time, the industry generally believed that there was a high probability of securing the first generic approval for this product. Prior to this, Jiangsu Hansoh had already received approvals in China for more than ten first generic products, including Enzalutamide Soft Capsules, Varenicline Tartrate Tablets, Empagliflozin Tablets, Paliperidone Extended-Release Tablets, Afatinib Dimaleate Tablets, Canagliflozin Tablets, Fosaprepitant dimeglumine for Injection, Deferasirox Tablets, and Icatibant Acetate Injection.

Another company approved for the generic version of Selexipag, Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., is a subsidiary of Huadong Medicine Group. Information shows that the company's Selexipag generic drug (Category 4) marketing application was officially submitted and accepted at the end of May 2023.

According to Johnson & Johnson's financial report, the sales of Selexipag Tablets have been steadily increasing year by year since its launch. The global sales in 2021 were $1.237 billion; the global sales in 2022 reached $1.322 billion, a year-on-year increase of 6.9%; the global sales in 2023 were $1.582 billion, a year-on-year increase of 16.43%.

Across the Chinese market, data from the MNI Network shows that since its launch, Johnson & Johnson's Selexipag tablets have seen skyrocketing sales. In 2021, sales in China's three major terminals and six key markets (hereinafter referred to as the domestic market) reached nearly 120 million yuan, a year-on-year increase of 261.3%; in 2022, domestic market sales exceeded 190 million yuan, a year-on-year increase of 68.2%; in 2023, domestic market sales of Selexipag tablets surpassed 200 million yuan, a year-on-year increase of 24.61%. With the approval of domestically produced generic drugs, the growth test for the original Selexipag market has arrived!

Chinese pharmaceutical companies spark a wave of generic drug production

Johnson & Johnson's Original Research to Face Fierce Competition

With billionsGeneric DrugThe large market cake graduallyMolding, currently in ChinaPioneerGenericMedicine Roadare increasing,Gradually Strengthening Focus on the Segmented Field of Selexipag Generic Drugs, everyone wants to get a piece of the cake,Some companies with faster pace are alsoStrive to achieve results in a short period, ensure a smooth market launch, and quickly capture a certain market position.

Overall, the competition among domestic companies for Selexipag Tablets in China is on the rise. In addition to the recently approved Hosen Pharma and Hangzhou Zhuyangxin Pharmaceutical Co., Ltd., other companies such as Hunan Fangsheng Pharmaceutical and Chongqing Shenghuaxi Pharmaceutical have also submitted Class 4 generic drug marketing applications for Selexipag Tablets, which are currently under review.

It is reported that the compound patent of the original Selexipag in China expired in 2022, and its crystal form patent will expire in 2030. Focusing on this potential product, in recent years, companies such as Changzhou Hengbang Pharmaceutical, Hunan Fangsheng Pharmaceutical, and Chongqing Shenghuaxi Pharmaceutical have been involved in the generic layout of Selexipag tablets.

Given that the original compound patent of Selexipag is facing a patent cliff, domestic pharmaceutical companies are seizing the opportunity to focus on generic production, breaking the previous monopoly. It is only a matter of time before domestically produced generics continue to enter the market and trigger "internal competition."

In March 2024, according to the official website of the CDE, the marketing application for the generic drug Selexipag Tablets (Category 4) by Chongqing Shenghuaxi Pharmaceutical was accepted by the CDE. To date, Chongqing Shenghuaxi Pharmaceutical has achieved approval or equivalent approval for 17 varieties, covering major therapeutic categories such as systemic anti-infective drugs, neurological drugs, cardiovascular and cerebrovascular drugs, and antitumor and immunomodulatory agents.

In October 2024, Hunan Fangsheng Pharmaceutical's Selexipag Tablets submitted for production approval as a Category 4 generic drug and are currently under review. Since the beginning of this year, Fangsheng Pharmaceutical has already submitted five new products for production approval, including Selexipag Tablets, Yangxue Qufeng Zhitong Granules, and Loxoprofen Sodium Gel Patches, all of which are under review.

Industry insiders believe that the current generic drug market in China is characterized by diversity and intense competition. In recent years, although the share of generic drugs in the overall pharmaceuticals market has fluctuated, they still maintain a dominant position. The domestic generic drug market also shows a trend towards high technological barriers and high added value. These products offer better clinical value, enhanced safety and efficacy, meeting the market demand for diverse drug forms and increasing medication options for patients.

Editor: Wanwan