Qilu Pharma and CSPC Zhongrun Race for First-to-File Elagolix Generic in China
Qilu Pharmaceutical
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CHIATAI TIANQING
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On January 8, according to the announcement on the CDE official website, the marketing application for Elagolix Tablets submitted by Qilu Pharmaceutical (Hainan) Co., Ltd. under Chemical Drug Registration Classification 3 was accepted. This is the second company to submit a marketing application after Chia Tai Tianqing.
Qilu Pharmaceutical and Chia Tai Tianqing, these two major generic drug giants, are once again competing in the same variety.
Qilu Pharmaceutical and Chia Tai Tianqing often compete for the first generic version of the same product simultaneously, and there have been multiple instances where both companies passed the evaluation on the same day.
In 2023, Pazopanib Tablets were approved on the same day for Qilu Pharmaceutical and Chia Tai Tianqing.On the same day, both companies were approved as the first domestic generic drug manufacturers; in 2024, for Eltrombopag Ethanolamine Tablets, two enterprises again achieved the first domestic generic approval on the same day.
The time for the first generic drug application is even tighter,Mirogabalin Besylate Tablets,Dapagliflozin Metformin Sustained-Release Tablets,Ruxolitinib Phosphate TabletsAnd so on, all have submitted their applications for listing one after another.
So this time, the product that Qilu Pharmaceutical and Chia Tai Tianqing are competing to replicateWhat is Elagolix Tablets?
Elagolix (also known as Orilissa) is a gonadotropin-releasing hormone (GnRH) receptor antagonist, mainly used to treat moderate to severe pain associated with endometriosis. The original research company is AbbVie. It was launched in the United States in 2018 under the trade name ORILISSA and has not been marketed domestically in China.
ORILISSA is the first oral therapy approved by the FDA for the treatment of moderate to severe pain associated with endometriosis in over a decade.
Source: AbbVie 2021 Annual Report
Endometriosis, often referred to as a "benign cancer" for women, commonly presents with symptoms such as dysmenorrhea, infertility, and chronic pelvic pain. According to literature, approximately 190 million women worldwide suffer from endometriosis. However, for a long time, there has been no safe and effective treatment for this condition.
ORILISSA is one of the few drugs with a clear indication for endometriosis.
In 2021, Elagolix was included in the national "Second Batch of Encouraged Generic Drug List."
Although it is included in the list of encouraged generic drugs and all patents for ORILISSA have expired, there are not many companies that have truly ventured into this product.
This variety of generic drugs needs to be completed.Phase III Clinical + BE Trial, Qilu Pharmaceutical Co., Ltd. was the earliest to start in August 2022Phase III clinical trials began recruiting in July 2023 by Chia Tai Tianqing, while Qilu Pharmaceutical's clinical progress was very slow. The study on subjects took more than 800 days, and eventually, Chia Tai Tianqing seized the opportunity.
In August 2025, CHIATAI TIANQING completedElagolix All ClinicalAfter the trial, the listing application was submitted first, taking the lead over Qilu Pharmaceutical.
Qilu Pharmaceutical and Chia Tai Tianqing are currently the frontrunners, with five other companies having received clinical approval, namely Chengdu Bright Future, Huahai Pharmaceutical,Livzon Group,Jinmeiji Pharmaceutical andJinling Pharmaceutical,But noPhase ⅢProgress.
In addition, raw materials from five companies have been registered: Nantong Changyou, Shandong Lango, Auris, Lepu, and Chengda.
ORILISSA is one of the few treatments available that canMedications for Endometriosis, but it is not perfect. Studies have shown that long-term use of ORILISSA can causeBone density loss, which is irreversible after discontinuation of the drug. The package insert specifies that the maximum treatment duration for ORILISSA is 24 months.
On the other hand, ORILISSA is priced very high in the United States, with monthly treatment costs close to 1,000 USD. Therefore, although sales are growing steadily, they still fall significantly short of the previously envisioned market scale.
Perhaps this is also one of the main reasons why there are not many domestic imitative enterprises being laid out.
Figure: ORILISSA English Instructions
Patients with endometriosis are not a small number, but there are few drugs available.Fortunately, the progress has been slow in recent years.EndometriosisThe research has finally started to make progress.
Hungary 2023Ricte Corporation and Sumitomo Pharma Co., Ltd. jointly developed and launchedRYEQO, approved in the EU for the treatment of endometriosis,RYEQO is a combination preparation, consisting ofRelugolix + Estradiol + Norethisterone Acetate Composition.
Currently, this combination has not been replicated by others, but one of its components, Relugolix Tablets, is a popular product for replication in China and has been included in the third batch of the national encouraged replication list.
Relugolix TabletsSimilarly requiredCompletedPhase III Clinical + BE Trial, CurrentlyTwelve companies have obtained clinical approval, with Jiangxi Xiangshan progressing the fastest and being the first to submit an application for marketing authorization.
Qilu Pharmaceutical Co., Ltd.Relugolix TabletsClinical Batch,Phase III clinical trials are currently underway.CHIATAI TIANQING Completes BE Trial, Qilu Temporarily Leads in This Product.
Relugolix TabletsMainly used for the treatment of prostate cancer, and can be combined with estrogen for endometriosis. After the single product is launched, it can be administered by doctors in combination therapy, which is considered to be...Elagolix tablets have formed competition.
In terms of new drugs, domestic companies have also made substantial progress. By December 2025,HMI-115, developed by Hope Medicine, has been granted Fast Track designation by the U.S. FDA. Previously, HMI-115 was included in the list of breakthrough therapy drugs by the CDE for the proposed treatment of moderate to severe pain associated with endometriosis.
We believe that there will be more drugs for treating endometriosis in the future.
Return toFor Elagolix Tablets,A product that can be targeted by both Qilu Pharmaceutical and CHIATAI TIANQING, two major generic drug giants, must possess certain market value. Although Qilu is currently a step behind, the final outcome of who wins or loses remains uncertain. The domestic market for related drugs in China is still relatively small and has significant room for development.
Reference: Amino Observation, Bing Medicine Talk, Today's Medicine
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