Qilu Pharmaceutical's Ranibizumab Injection Becomes First Domestic Biosimilar Approved, Challenging for Leadership in China's Billion-Dollar Ophthalmic Market

Aug 26, 2024 17:54 CST Updated 17:54

Qilu Pharmaceutical

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Recently (August 19), according to the official website of the National Medical Products Administration,Qilu PharmaceuticalTheRanibizumab Injection(QL1205) has been approved for marketing,And is deemed to have passed the quality and efficacy consistency evaluation for generic drugs. This productYesThe first domestically produced biosimilar of ranibizumab successfully approved in China,For patients with fundus diseases。

Source: National Medical Products Administration

Ranibizumab was originally developed by Roche,It is a revolutionary VEGF inhibitor. Since its first launch in the United States in June 2006, it has been widely used to treat ophthalmic diseases such as wet age-related macular degeneration, becoming the world's first anti-VEGF drug used in the ophthalmology field.

Over 1.6 Billion Large Variety

Expected to return to"Top Brother" Position

According to data from the CKDM-IC system, the sales of Ranibizumab Injection in grade hospitals in 2023Breaking a nearly 7-year high, reaching 1.648 billion yuan, an increase of 9.5% year-on-year;Sales of 409 million yuan in the first quarter of 2024, an increase of 4.6% over the same period last year.

Sales Situation of Ranibizumab Injection in Hospitals of Various Levels

Source: Sino Health Kaisi System

As the first-generation anti-VEGF drug in the field of ophthalmic treatment, Ranibizumab was once a blockbuster drug in the global ophthalmic drug market. It is reported that from 2011 to 2021, the annual sales of Ranibizumab worldwide basically remained at more than 3 billion US dollars, reaching its peak in 2014 with over 4.3 billion US dollars.

From the perspective of the Chinese market, the ophthalmology treatment field is regarded as the "golden track" in the medical investment industry, with extensive market demand and significant development potential.According to the CKDM system, in 2023Ophthalmic MedicationsSales in tiered hospitals reached 12.6 billion yuan, while retail terminal sales amounted to 7.8 billion yuan.Total Sales of 20.4 Billion Through Two Major ChannelsYuan.In the first quarter of 2024, the two major channels combined for sales of 5.1 billion yuan.

Sales of Ophthalmic Drugs in Hospitals Across China

Source:Zhongkang Kaisi System

From the market landscape, currentlyRanibizumab, Conbercept, AfliberceptReferred to as the three giants of anti-VEGF drugs in China.In 2006, asThe world's first VEGF monoclonal antibody for eye diseases,RanibizumabApproved for marketing. In the first year of its launch, it generated sales of $520 million.The following year, it soared directly to $1.43 billion.

Lucentis entered China in 2012., occupying the main ophthalmology market in China at a price of 9,800 yuan per vial;Immediately following,Conbercept was approved for marketing in China in November 2013.; and Aflibercept is the highest-selling anti-VEGF drug globally.Ophthalmic drugs, but entered China in 2018, currently showing rapid growth and ranking third.

The First Quarter of 2024Ophthalmic Medications

Top 10 Hospitals in China by Sales Revenue (Unit: Billion Yuan)

Source: CKDMed System, Xinchangjie整理

This approval for marketing of Qilu Pharmaceutical Co., Ltd. is helpfulRanibizumabThe continuous growth of the pharmaceutical market,Or there is hope inSurpassing Conbercept in 2024,Back to"Big Brother" Position.

In fact, Qilu Pharmaceutical has been deeply involved in the ophthalmic drug market for many years.In December last year, Qilu Pharmaceutical Co., Ltd.Aflibercept BiosimilarApproved for marketing,The first generic version in China.With the successful launch of biosimilars for two of the best-selling ophthalmic products, Qilu Pharmaceutical has further solidified its leading position in the ophthalmic pharmaceuticals field.

The Ophthalmology Track with Over 100 Billion in Investment Continues to Expand

In the Chinese market, since its approval for marketing in December 2011, ranibizumab has been approved for six indications, including wet age-related macular degeneration (AMD), macular edema secondary to retinal vein occlusion (RVO-ME), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), retinopathy of prematurity (ROP), and diabetic retinopathy (DR).

In addition to being approved in China this time, Qilu Pharmaceutical's Ranibizumab Injection received marketing authorization from the EU in January this year. The company stated,This is not only the first domestically produced ranibizumab to be approved in the EU, but also the first domestically produced ophthalmic biologic to successfully "go global."

Currently, Qilu Pharmaceutical has four biological drugs under review for production.Since 2024, Qilu Pharmaceutical's biopharmaceutical innovation has accelerated even further, with four new biologics receiving approval, including Denosumab Injection, Romiplostim N01 for Injection, Trastuzumab for Injection, and Ranibizumab Injection. These approvals have further enriched the company’s product portfolio.

According to Frost & Sullivan data, from 2016 to 2020, the market size of ophthalmic drugs in China grew from 15.1 billion yuan to 18.8 billion yuan, with a compound annual growth rate of 5.7%;It is expected to reach 44 billion yuan by 2025.It will reach 116.6 billion yuan by 2030.

2015-2030 Global and China Ophthalmic Drugs Market

Source:Frost&Sullivan

With the increasing attention to ophthalmologyThe Increasing Demand for Medications，InLast YearAgainst the backdrop of a collective slump in pharmaceutical stocks,Some ophthalmic drug companies have also made a fortune, such asKanghong PharmaceuticalStock Price Rose Over 20% Against the Trend in 2023。

Apart from Kanghong Pharmaceutical, manyThe performance of ophthalmic drug companies is also impressive. For example,Pure Vision Eye HospitalThe disclosed 2023 performance report also shows,Achieved operating revenue of 2.718 billion yuan in 2023, an increase of 57.50% year-on-year; net profit attributable to shareholders of the listed company was 268 million yuan,An increase of 1202.56% year-on-year.

Source:Corporate Announcement

AndXingqi Eye DropsThe disclosed Q1 2024 report shows that the company achieved revenueCollectEntered 350 million yuan, an increase of 22.10% year-on-year; net profit of 34.749 million yuan, an increase of 79.59% year-on-year. The company's disclosed 2023 financial report shows,The company achieved operating revenue of 1.468 billion yuan, a year-on-year increase of 17.42%.; Net profit of 240 million yuan, a year-on-year increase of 13.39%.

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