Goserelin microsphere preparation phase III clinical success, the market of billions of large varieties is about to be reshuffled!

Goserelin, which has not had a new dosage form on the market for more than two decades, is about to usher in a new microsphere dosage form
.

On September 6, Luye Pharma announced that its self-developed anti-tumor innovative preparations for injection of Goserelin Acetate Sustained Release Microspheres (LY01005) has completed a phase III clinical study for the treatment of prostate cancer in China, reaching the preset end point.
The product can be used for the treatment of various diseases such as prostate cancer, breast cancer and endometriosis
.

Luye Pharma has been deeply involved in the field of microsphere technology for many years.
After launching the first microsphere product, Risperidone Microspheres (II) (trade name: Recinto) for injection at the beginning of this year, Luye Pharma’s another microsphere product, LY01005 It seems to bear more market expectations
.

Benchmarking the MNC "Evergreen Variety", the sword index billion market

Benchmarking the MNC "Evergreen Variety", the sword index billion market

It is understood that Gonadotropin-releasing hormone (GnRH) agonists such as Goserelin need to be sustained-released clinically to achieve a sustained drug release effect, thereby producing effective therapeutic effects
.

But up to now, only AstraZeneca's Goserelin subcutaneous implant Norad is the only product that can achieve the sustained-release effect of goserelin, which is also the benchmark product of LY01005

As early as 1996, Norad’s 3.
6mg specification was approved to enter the Chinese market.
For more than two decades since then, Norad, as the only formulation of goserelin on the market, is the current prostate cancer treatment.
The first-line drugs have always been AstraZeneca's "evergreen varieties"
.

According to AstraZeneca’s financial report, Norad will contribute US$888 million in sales to the company in 2020
.

In the Chinese market, IMS data shows that in the first half of 2021, the sales of the product in the Chinese hospital market increased by 16.

Norad has been able to remain "evergreen" for decades and become one of AstraZeneca's best-selling oncology drugs, which is inseparable from the huge market demand
.

The latest global cancer burden data from the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020 shows that prostate cancer is the world’s second most common malignant tumor in men.

In addition, IARC's latest global cancer burden data for 2020 pointed out that breast cancer has the largest number of new cases in the world, reaching 2.
26 million cases, accounting for 11.
7% of the annual number of new cancers
.

Effectively solve clinical pain points and improve patient experience is expected

Effectively solve clinical pain points and improve patient experience is expected

Although the market LY01005 points to is large, it is the market coverage and sales achievements that AstraZeneca has achieved with the resources and capabilities of multinational pharmaceutical companies and years of deep market cultivation.
As a new recruit, what does LY01005 use to "contest" the former?

Luye Pharmaceutical disclosed the results of the Phase III study of the product in its announcement.
LY01005 is injected intramuscularly at a dose of 3.
6 mg every 28 days to treat prostate cancer, which can effectively control testosterone to castrate levels.
The clinical efficacy is comparable to that of the control drug, and the injection site is not good.
Compared with the control drugs, the response was significantly improved, the patient compliance increased, the incidence of other adverse events was similar, the safety characteristics were similar, and the overall clinical safety was well tolerated
.

In addition, Luye Pharmaceutical revealed that in addition to the field of prostate cancer treatment, LY01005's phase III clinical study for the treatment of breast cancer in China is also underway

Public information shows that GnRH agonist drugs can maintain a high castration rate, and it is difficult for such drugs to achieve breakthroughs in efficacy.
However, there are clinical pain points that need to be improved in terms of patient tolerance and compliance
.

For example, Norad has a 3.

The "Guidelines for the Design of GnRH Agonists for Advanced Prostate Cancer Clinical Trials" issued by CDE in December last year stipulated that improved new GnRH agonist drugs should be optimized in terms of structure, dosage form, prescription technology, route of administration, etc.
, and similar products The comparison should show a clear clinical advantage
.

LY01005 obviously meets this guiding principle and closely follows the clinical needs: through innovative microsphere technology, LY01005, compared with the control drug goserelin implant, significantly reduces the occurrence of adverse reactions at the injection site without affecting the clinical efficacy.

Therefore, although it is an innovation in dosage form, it can solve the pain points that have spanned the clinic for many years.
The successful completion of Phase III of LY01005 has indeed brought good news for patients with prostate cancer treatment
.

Luye Pharma stated that it will submit a marketing application in China based on LY01005's Phase III clinical results of prostate cancer

From Recinto to Goserelin microspheres, the prototype of the microsphere moat has emerged

From Recinto to Goserelin microspheres, the prototype of the microsphere moat has emerged

Luye Pharma stated that LY01005 is another innovative preparation independently developed based on its innovative microsphere technology platform following Rexinto
.

Rexinto is China’s first self-developed, globally registered, innovative microsphere preparation with independent intellectual property rights, and LY01005 is expected to become the world’s only goserelin microsphere product for the treatment of prostate cancer

As early as when Ruixintuo was approved at the beginning of this year, some analysts in the industry believed that Luye Pharma's innovative microsphere technology research and development platform, which has been deeply cultivated for many years, has since successfully achieved industrialization and began to show its global leading advantages
.
Now that LY01005 has successfully "run" Phase III clinical trials, it undoubtedly has once again verified the technology research and development capabilities of the Luye Pharmaceutical Microsphere Platform
.

In fact, the research and development of new drugs has always been a huge "system engineering", in which the construction of the technology platform and the connection of the entire industry chain require pharmaceutical companies to exert the spirit of "ascetic"
.
From the perspective of Luye Pharma's practice, it took nearly ten years to fully open up the microsphere technology platform and related industry chains, achieving a breakthrough from zero to one
.
Now it is rapidly ushering in another major milestone in the field of microspheres.
In fact, it is also the result of painstaking accumulation in the past ten years, and perhaps only the starting point
.

According to information from Luye Pharmaceuticals, it has formed a rich product portfolio in the field of microsphere technology: except for LY01005.
Rexinto for the treatment of schizophrenia has been approved in China for the treatment of schizophrenia and schizoaffective disorder.
Clinical trials of paliperidone palmitate sustained-release suspension injection (LY03010) and microsphere injection (LY03009) for the treatment of Parkinson’s disease and restless legs syndrome are underway
.

These microsphere products have a dosing cycle ranging from one week to three months, have obvious clinical advantages, better effectiveness and safety, and can improve patient compliance
.
Subsequent new drugs will form a rich product portfolio with Luye Pharma's marketed products to strengthen its leading edge in this field
.
The moat built by Luye Pharma's microsphere technology is now in its embryonic form
.