Recently, Innovent Biologics received good news that its self-developed new ophthalmic drug, Tetuinumab N01 Injection (IBI311), was approved for marketing under the trade name: Symbimin. This is China's first and the world's second IGF-1R antibody drug for the treatment of thyroid eye disease (TED).

This is also the first blockbuster new drug approved by Innovent Biologics this year. At the same time, the company's other two highly anticipated potential blockbuster products - Masudopeptide and Piconazole are also expected to be approved for marketing this year, opening up a rapid growth channel in the non-tumor field.
China's first
Thyroid eye disease (TED), also known as GRAVES eye disease, is an autoimmune disease closely related to thyroid disease. According to statistics, about 25%-50% of patients with diffuse goiter and hyperthyroidism will have varying degrees of GRAVES eye disease, which ranks first in the incidence of adult orbital diseases. In recent years, the disease has shown a clear trend of younger patients.

Patients with thyroid eye disease not only have symptoms of endocrine system disorders caused by abnormal thyroid function, but also have eye symptoms such as photophobia and tearing, foreign body sensation in the eye, restricted eye movement and eye pain. As the disease progresses, severe cases may experience orbital deformities, diplopia, and even blindness.

Since it is an autoimmune disease, biological agents targeting the cause will have great potential.

IGF-1R (Insulin-like growth factor 1 receptor) is a tetrameric transmembrane receptor tyrosine kinase found on the surface of human cells. Studies have shown that IGF-1R is widely expressed in normal human tissues and is highly expressed in thyroid eye disease (TED). Activation of IGF-1R can stimulate cell proliferation, survival, transformation, metastasis and angiogenesis, while inhibition of IGF-1R can alleviate and improve the symptoms of thyroid eye disease (TED).

In January 2020, Tepezza (Teprotumumab), developed by Horizon Therapeutics (acquired by Amgen), was approved for marketing in the United States, becoming the world's first IGF-1R monoclonal antibody for the treatment of chronic (inactive) thyroid eye disease (TED). Compared with other previous treatments, Tepezza can effectively reduce eye bulging in addition to eliminating inflammation. Patients treated with Tepezza experienced an unprecedented reduction in eye bulging, which previously could only be treated surgically after the active disease ended.

The unique and excellent therapeutic effect of the drug made its sales exceed US$800 million in the first year of its launch, and the sales of the drug reached US$1.85 billion in 2024.

However, Tepezza treatment is expensive, requiring nearly RMB 3 million to complete a course of treatment. More importantly, the drug is not yet available in the country.

Innovent Biologics' Symbiosis is the first IGF-1R antibody approved in China and the second in the world. It is reported that its treatment cost is 1/15 of Tepezza, which is of great significance to domestic patients with thyroid eye disease.

The Phase 3 RESTORE-1 study showed that after 24 weeks of treatment with IBI311, the response rate of patients with proptosis regression ≥ 2 mm was as high as 85.8%, inflammation and quality of life were also significantly improved, and the safety profile was good.
Start a new growth engine

In the past few years, Innovent Biologics has built a rich pipeline matrix in the field of oncology through a combination of independent research and collaboration.

Among them, Sintilimab is the first PD-1 tumor immunotherapy to be included in the national medical insurance catalog. It is of great significance in the development of innovative drugs and tumor immunotherapy in China, and has become the most important performance pillar of Innovent Biologics in the past few years. According to Yaozhi data, from 2019 to the first half of 2024, the cumulative sales of Sintilimab in domestic public medical institutions have exceeded 10 billion yuan.

In the development of the next generation of anti-tumor drugs, Innovent Biologics has adopted the "IO+ADC" strategy and has deployed many potential pipelines, including combination therapies (CTLA-4 monoclonal antibody + sintilimab), new generation ADC drugs: IBI354 (HER2 ADC), IBI3009 (DLL3 ADC), IBI343 (CLDN18.2 ADC), and bispecific drugs: IBI363 (PD-1/IL-2α-bias).

However, most of these anti-tumor drugs face fierce competition or are still in the early clinical stages. Judging from the current layout, Innovent's next "blockbuster" is likely to be in the non-tumor field.

IBI311, a new drug for thyroid eye disease that has just been approved for marketing, is a potential blockbuster product. In addition, Innovent Biologics has two other non-oncology blockbuster new drugs that are expected to be approved for marketing this year: Mastolide and Piconazole.

Masto peptide

The popularity of GLP-1 drugs around the world is obvious to all. In China, Innovent Biologics has taken the lead.

Masudopeptide is a GCGR/GLP-1R dual agonist introduced by Innovent Biologics from Eli Lilly. The main function of GLP-1 receptor agonist is to suppress appetite, delay gastric emptying, and reduce energy intake. GCG receptor agonist has an important regulatory effect on the body's fat metabolism: on the one hand, it inhibits fat synthesis, and on the other hand, it promotes fat decomposition and increases energy consumption, playing a synergistic role of 1+1>2. Therefore, Masudopeptide has the potential to surpass semaglutide in weight loss effect.

Its Phase III GLORY-1 study on overweight Chinese patients showed that at 32 weeks, the body weight of subjects in the 4mg and 6mg dose groups decreased by 10.54% and 13% respectively from baseline (placebo-corrected data). At 48 weeks, the body weight of subjects in the 4mg and 6mg groups decreased by 11.3% and 14.31% respectively from baseline (placebo-corrected data).

In terms of safety, the incidence of serious adverse events in the 4 mg, 6 mg and placebo groups was 4.4%, 3.5% and 6.3%, respectively; the proportion of discontinuation due to adverse events was 1.5%, 0.5% and 1.0%, respectively.

A Phase I clinical study targeting overweight or obese patients worldwide showed that a high dose of 16 mg of Mastolide resulted in a maximum weight loss of 21% in 20 weeks, while the placebo group showed almost no change (-0.1%). The main adverse events were mild to moderate nausea, vomiting, and diarrhea, and no serious adverse events were observed.

In addition, Mashidu peptide also has unique effects on liver benefits and improving obesity-related inflammation. Currently, the drug has been submitted for marketing approval for two indications, weight management and adult type 2 diabetes. Innovent Biologics expects these two indications to be approved for marketing in the first and second half of 2025, respectively.

Piconazole

Autoimmune disease is another “big drug” market.

Innovent Biologics' picornabiline (IBI112) was submitted for marketing approval last year for the treatment of moderate to severe plaque psoriasis and is expected to be approved for marketing by the end of this year.

The drug is an IL-23p19 monoclonal antibody with best-in-class efficacy potential and long-interval dosing.

According to a press release from Innovent, picornabilineumab is the world's first IL-23p19 antibody drug in a registered Phase III clinical trial with a primary endpoint of more than 80% of subjects achieving PASI 90 at week 16. It also has the longest maintenance dosing interval (once every 12 weeks) among similar biological drugs.

The CLEAR-1 study showed that at week 16, the proportions of subjects achieving PASI 90 and sPGA 0/1 reached 80.3% and 93.5%, respectively. The proportion of subjects achieving PASI 75, PASI 100, sPGA 0, and DLQI 0/1 at week 16 was significantly higher than that of placebo.

In addition, the Phase II clinical study of picrobactam for the treatment of ulcerative colitis also achieved the primary endpoint.

In addition to these new drugs that are expected to be launched this year, Innovent has several pipelines under development in non-oncology fields, including:

IBI302: This drug is an anti-VEGF-anti-complement bispecific recombinant fully human fusion protein that demonstrates non-inferior visual acuity benefits to aflibercept, durability of efficacy at longer dosing intervals, and the potential to improve macular atrophy. Currently, the Phase 3 STAR clinical trial of IBI302 8mg for the treatment of nAMD is recruiting patients.

IBI128: Tegusostat tablets, a non-purine analogue - xanthine oxidase inhibitor (XOI) introduced by Innovent Biologics from LG Chem of South Korea, is currently undergoing Phase 2 clinical trials in China.

In the future, non-oncology fields (ophthalmology, cardiovascular and metabolic, and autoimmune) may become new important sources of revenue for Innovent.

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