13 Blockbuster First-to-File Generics Poised for Approval: East Sunshine Pharmaceutical, Hansoh, and Nanjing Chia Tai Tianqing Set to Disrupt an RMB 800 Billion Market

Auspicious Start to the Year! Nine First Generic Drugs Approved, Hefei Lifeon Pharmaceutial Co., Ltd. and JIUDIAN PHARMACEUTICAL Break Through

In just the first month of 2024 (as of January 31), nine first-to-market generic drugs have been successfully approved (counted by product name + company, including those approved on the same day). Leading domestic giants such as Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd. took the lead, while prominent companies like Hefei Lifeon Pharmaceutial Co., Ltd. and JIUDIAN PHARMACEUTICAL successfully broke through. The market for first-to-market generics in China continues to thrive.

Table 1: First Generic Drugs Approved for Marketing in January 2024

Source: MiNeiNet China Application Progress (MED) Database

Eltrombopag Ethanolamine Tablets, a non-peptide thrombopoietin receptor agonist developed by Novartis, achieved global sales exceeding $2 billion in 2022. The original Eltrombopag Ethanolamine Tablets entered the Chinese market in 2017, were included in the National Reimbursement Drug List (NRDL) in 2019, and have been part of the negotiation directory since 2021. It is indicated for adult and pediatric patients aged 6 years and above with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an inadequate response to treatments such as corticosteroids and immunoglobulins, as well as for patients with severe aplastic anemia (SAA) who have insufficient response to immunosuppressive therapy. In 2022, the combined sales of Eltrombopag Ethanolamine Tablets in China's three major terminals and six key markets (see the end of the article for statistical scope) exceeded 700 million yuan. To date, more than 10 domestic pharmaceutical companies in China have filed for generic production of Eltrombopag Ethanolamine Tablets. Jiangsu Aosaikang Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical Co., Ltd., and Sichuan Kelun Pharmaceutical Co., Ltd. received approval for the first generic version on the same day.

Itraconazole Oral Solution, developed by Johnson & Johnson, belongs to systemic antifungal drugs and is mainly used for treating oropharyngeal and/or esophageal candidiasis in HIV-positive patients or those with weakened immune systems. For patients with hematological malignancies, bone marrow transplants, or anticipated neutropenia (i.e., <500 cells/μl), it can prevent invasive fungal infections when standard treatments are not applicable and sensitivity to itraconazole is expected. The product has been included in the National Medical Insurance Catalog. To date, three domestic pharmaceutical companies in China have applied for the generic production of Itraconazole Oral Solution. Only Hefei Lifeon Pharmaceutial Co., Ltd., under Hefei Lifeon Pharmaceutical, has been approved and obtained the first generic production in China, with no other company’s application currently under review.

Ebastine Oral Solution is mainly applicable for the symptomatic treatment of allergic rhinitis (seasonal and perennial) with or without allergic conjunctivitis, as well as chronic idiopathic urticaria. The original product has not yet entered the Chinese market. To date, eight domestic pharmaceutical companies have applied for the generic marketing of Ebastine Oral Solution, with Hunan Pudao Medicine, a subsidiary of JIUDIAN PHARMACEUTICAL, securing the first generic approval in China.

13 Heavyweight First Generic Drugs Are Coming! Dongyang Light Medicine, Nanjing Chia Tai Tianqing Ready for Action

According to data statistics from Menet, since 2017, there have been over 200 generic drugs applied for marketing approval under review that have not yet been approved for any domestic companies (counted by product name). Which blockbuster first-to-market generics are expected to be approved for marketing in 2024? Next, let's explore together.

Table 2: Blockbuster First Generic Drugs Expected to Be Approved in 2024

Source: MiNeiNet China Application Progress (MED) Database

Fingolimod is a sphingosine-1-phosphate receptor modulator, with global sales exceeding $2 billion in 2022. The original Fingolimod Hydrochloride Capsules were approved for entry into the Chinese market in 2019 and successfully negotiated to be included in the National Reimbursement Drug List (NRDL) in 2020, restricted to patients aged 10 years and above with relapsing-remitting multiple sclerosis (RMS).

In February 2020, Guangdong Dongyangguang Pharmaceutical was the first to file a Class 4 generic listing application for Fingolimod Hydrochloride Capsules in China. In July 2022, Beijing Kangtini Pharmaceutical became the second company to file for production. Currently, only these two domestic pharmaceutical companies are competing for the first generic approval in China.

Selexipag is an orally active, highly selective, long-acting non-prostaglandin prostacyclin receptor (IP receptor) agonist. It is the first prostacyclin-class drug that can be administered orally, with global sales exceeding $1.3 billion in 2022. The original selexipag tablets entered the Chinese market in 2018 and were successfully negotiated into the National Reimbursement Drug List (NRDL) in 2019, indicated for patients with WHO functional class II-III pulmonary arterial hypertension (WHO Group 1). In 2022, the combined sales of selexipag in China's three major terminals and six key markets exceeded 100 million yuan.

In June 2021, Hansoh Pharma's subsidiary, Changzhou Hengbang Pharmaceuticals, was the first to file for the Class 4 generic listing of Selexipag Tablets. In May 2023, Hangzhou Zhuyangxin Pharmaceuticals became the second to file for production. Currently, only these two Chinese pharmaceutical companies are competing for the first domestic generic approval in China.

Carfilzomib, a proteasome inhibitor, achieved global sales of over $1.2 billion in 2022. The original injectable Carfilzomib entered the Chinese market in 2021 and successfully entered the 2022 National Reimbursement Drug List (NRDL) through negotiation. It is indicated for adult patients with relapsed or refractory multiple myeloma who have previously received at least two prior treatments, including proteasome inhibitors and immunomodulatory agents.

Figure 1: Companies applying for the generic listing of injectable carfilzomib and under review

Source: MiNeiNet China Application Progress (MED) Database

Jiangsu Hansoh Pharmaceutical Group Co., Ltd. was the first to receive clinical approval for the Type 3 generic version of carfilzomib for injection in June 2020 after its application, and made another move in September 2021. Subsequently, seven domestic pharmaceutical companies, including Shanghai Innovation Pharmaceuticals, Qilu Pharmaceutical (Hainan), and Sichuan Huiyu Pharmaceuticals, successively reported production.

Ruxolitinib is the world's first JAK inhibitor, with global sales exceeding 1.5 billion US dollars in 2022. The original research product, Ruxolitinib Phosphate Tablets, was approved to enter the Chinese market in 2017 for adult patients with intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF). In April 2023, it was approved for a new indication to treat patients aged 12 years and older with acute graft-versus-host disease (aGVHD) who have had an inadequate response to corticosteroids or other systemic therapies. Currently, all approved indications for this product have been included in the 2023 National Medical Insurance Negotiation Catalog.

Figure 2: Sales of Ruxolitinib Phosphate Tablets in China's Three Major Terminals and Six Major Markets (Unit: Ten Thousand Yuan)

Source: MiNei Network Pattern Database

In China's three major terminals and six major markets, the combined sales of Ruxolitinib Phosphate Tablets exceeded 600 million yuan in 2021 and rose to more than 660 million yuan in 2022. In terms of channels, the main sales arenas for Ruxolitinib Phosphate Tablets are public hospital terminals (urban public hospitals + county public hospitals) and retail pharmacy terminals (urban physical pharmacies + online pharmacies). After entering the national medical insurance negotiation directory in 2019, the product’s sales in public hospital terminals rapidly increased.

In July 2022, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Nanjing) was the first to file a Type 4 generic drug application for Ruxolitinib Phosphate Tablets. In May 2023, Chengdu Yuandong Biological Pharmaceutical Co., Ltd. became the second company to file for production, and in January 2024, Hansoh Pharma (Chongqing) was the third to file for production. The number of competitors vying for the first generic version of this product is gradually increasing.

Salmeterol and Fluticasone is a blockbuster drug for obstructive airway diseases, with global sales exceeding 1.1 billion pounds in 2022. The combined sales of the original Salmeterol and Fluticasone inhalation powder in China's three major terminals and six major markets exceeded 1.6 billion yuan in 2022.

Salmeterol Tiotropium Inhalation Powder has attracted seven domestic pharmaceutical companies to apply for generic drug marketing in China, but currently only three are under review and approval. Joincare Pharmaceutical Group reported production in February 2023.

Linaclotide is the world's first guanylate cyclase agonist, with global sales exceeding $1 billion in 2022. The original linaclotide capsules entered the Chinese market in 2019 and were included in the national medical insurance negotiation directory in 2020, indicated for adult constipation-predominant irritable bowel syndrome (IBS-C). In 2022, the total sales of linaclotide in China's three major terminals and six major markets exceeded 100 million yuan.

As of now, four domestic pharmaceutical companies in China have filed for the generic production and marketing of Linaclotide capsules, but only two are currently under review. Qilu Pharmaceutical (Hainan) submitted its application in March 2023.

Apalutamide is a second-generation non-steroidal androgen receptor (AR) inhibitor that effectively prevents androgens from binding to the receptor, blocks AR translocation to the nucleus of tumor cells, and inhibits androgen-induced tumor cell growth. In 2022, global sales of apalutamide exceeded $1.8 billion. The original apalutamide tablets were approved for entry into the Chinese market in 2019 and successfully negotiated for inclusion in the National Reimbursement Drug List (NRDL) in 2021. Its use is restricted to adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis.

Figure 3: Sales of Apalutamide Tablets in China's Three Major Terminals and Six Major Markets (Unit: Ten Thousand Yuan)

Source: MNI Network Pattern Database

In China's three major terminals and six major markets, the combined sales of apalutamide tablets exceeded 100 million yuan for the first time in 2022, reaching more than 480 million yuan, with 360 million yuan in the first half of 2023. In terms of channels, after apalutamide tablets entered the national medical insurance negotiation directory, their sales in public hospital terminals rapidly increased, becoming the main sales battlefield.

In September 2023, Qilu Pharmaceutical (Hainan) was the first to file a Type 4 generic listing application for Apalutamide Tablets. In November of the same year, Sichuan Kelun Pharmaceutical became the second company to file for production, and in January 2024, Chengdu Yundong Biopharmaceutical became the third. Currently, the acceptance numbers of these three Chinese pharmaceutical companies are under review.

Conclusion

The aforementioned 13 blockbuster products are distributed across six major market categories: antitumor and immunomodulatory agents, hematological and hematopoietic system drugs, cardiovascular and cerebrovascular system drugs, respiratory system medications, nervous system drugs, and digestive system and metabolic medications. The combined scale of these six major market categories in China's three main terminals and six large markets exceeded 800 billion yuan in 2022, and a new round of market reshuffling is about to unfold. As for how many first-to-market generic drugs will ultimately be approved in 2024, MiNe News will continue to track and report—stay tuned.

Source: MiNeiNet database, etc.

Note: The drug competition pattern of China's three major terminals and six markets in the MiNe Network covers urban public hospitals, county-level public hospitals, urban community centers, 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. Approval data statistics are as of February 7, and application data statistics are as of February 10.