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Recently, Innovent Biologics has received a series of good news, with four blockbuster good news coming in February alone.
On February 22, the PD-1 inhibitor Tyvyt (sintilimab injection) was officially approved for marketing by the Drug Administration of Macao, China.
On February 21, the company entered into a clinical research and supply cooperation agreement with immvirx pty limited ("immvirx") to carry out clinical research cooperation on the combination of sintilimab injection (PD-1 inhibitor, trade name: Tyvyt) and oncolytic virus candidate IVX037**.
On February 20, the phase clinical study of recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody injection (IBI311) in Chinese subjects with thyroid eye disease (TED) met the primary endpoint.
On February 7, the domestic marketing of GLP-1R GCGR dual agonist Masdotide was accepted by CDE.
Founded more than 10 years ago, Innovent has caught up with the first wave of PD-1 craze in China and rapidly moved from Biotech to BioPharm, but it is still mired in losses.
Under the involution, more potential of sintilimab is explored
As the leader of Innovent Biologics, sintilimab's slowdown in growth and even declining sales in recent years has put a lot of pressure on Innovent Biologics.
After being approved in 2018, it became the first PD-1 to enter the health insurance in 2019. In 2020, sintilimab sales doubled from 101.5 billion yuan rose to 24900 million yuan, in the same year, in the first echelon of domestic PD-1, Hengrui Pharmaceutical sold 48900 million yuan, Junshi Biosciences 100.3 billion, BeiGene 11200 million yuan, sintilimab is second only to Hengrui's tirapizumab.
However, in 2020, with the inclusion of the three PD-1s of Junshi Biosciences, Hengrui Pharmaceutical, and BeiGene into the medical insurance with an average reduction of 78%, the advantages of sintilimab gradually disappeared, and the second echelon of PD-1 joined the competition, and in 2022, the sales of sintilimab suffered the first decline after the launch, and only 20 were sold2.9 billion yuan, a year-on-year decrease of more than 30% compared with the sales of nearly 3 billion yuan in 2021.
In 2022, sintilimab sales performance was the only product in the PD-1 four tigers to show negative growth, and in the face of performance shock, Innovent Biologics is committed to bringing sintilimab to overseas markets in North America, Europe and other regions, but in March 2022, the FDA rejected the marketing application of sintilimab. The blockage of sintilimab's overseas expansion has cast a shadow on its sales growth, and the entry into the Macau market is also a new breakthrough for sintilimab outside the mainland market.
At present, Innovent is still focused on the expansion of new indications for sintilimab, and the seventh new indication of sintilimab for non-small cell lung cancer with failed EGFR-TKI** was included in the 2023 edition of the National Reimbursement Drug List at the end of December 2023. In the first three quarters of 2023, Innovent Biologics' product revenue was approximately RMB4.1 billion, of which sintilimab's sales revenue was RMB2$800 million (about $19.19.)6.7 billion yuan), a year-on-year increase of 19%, accounting for about 47% of the overall product revenue, although sales have increased, but in the fierce PD-1 market, sintilimab's competitiveness is not outstanding.
In terms of mechanism of action, sintilimab injection and oncolytic virus IVX037 have complementary effects in mobilizing the immune system to kill tumor cells, and the combination of IVX037 will bring stronger anticancer activity and immunostimulatory activity compared with checkpoint inhibitor monotherapy**, and may bring additional response in cancers that are prone to drug resistance to checkpoint inhibitor monotherapy**.
IMMVIRX is currently conducting a Phase I clinical study of IVX037 in Australia (NCT05427487). The clinical IB study is scheduled to start in Australia in mid-2024, and under the collaboration agreement, Innovent will provide sintilimab injection for the multi-center clinical trial.
In the Red Sea of PD-1, Innovent will continue to explore the potential value of sintilimab.
Step on the middle of the wind and run to the ** aircraft carrier market
* In the pharmaceutical market, any wind and grass seems to be able to set off "huge waves".
In the third quarter of 2023, semaglutide will be frequently searched, which has triggered a wave of **concept stocks** of A-shares. With the blessing of the recent movie "Hot and Hot", the concept of medicine is still hot during the Spring Festival, detonating the market again, and many of the drug concept sector have risen sharply, the data shows that as of February 20, the drug index is 261%, in the past 5 trading days, the **drug index has accumulated more than 18%.
According to Morgan Stanley's estimates, by 2030, the market size of ** drugs is expected to exceed 54 billion US dollars, which is expected to surpass PD-1 PD-L1 to become the largest drug in the global market, and according to Caitong, it is expected that in 2025, China's ** drug compliance market is expected to exceed 12 billion yuan.
At present, GLP-1 receptor agonists have become the main direction of the future first-class drug track, and there is still a large gap in China's weight loss market. The only domestic GLP-1** drugs approved for marketing in China are Huadong Pharmaceutical's liraglutide biosimilar, Renhui Biotech's benaglutide, and Eli Lilly's tirpatide.
Innovent Biologics' Mastotide is the GLP-1R GCGR dual agonist with the fastest clinical development progress in the world, and Laglutide, benaglutide and tirpatide marketed in China are all GLP-1 single-target drugs. After years of hard work, the marketing application of Maxodotide for long-term weight control in obese or overweight patients was accepted by the CDE on February 7, and Innovent Biologics' stock price rose sharply on the same day.
In terms of weight loss effect, Max Dou peptide has the potential of best-in-class. According to the previously disclosed data, the 9mg dose of Masdotide in the domestic obese test population (average BMI: 34.).3 kg m2) after 24 weeks of continuous use, 154% amplitude, about 147kg；Secondly, Masdotide also showed a better weight loss effect at low doses, 3mg, 4After 24 weeks of continuous use, 5 mg and 6 mg changed by 8 percent body weight in the three dose groups compared to the placebo group26%、−11.60%、−12.62%, which has exceeded the injection effect of 68 weeks of semaglutide.
In addition to Masdotide, the dual-target GLP-1 receptor agonist under development in China has made the fastest progress in Hengrui Pharmaceutical's HRS9531, but it has just entered the phase of clinical trials.
If it is successfully approved, it can have at least 2-3 years of dual-target GLP-1 exclusivity in the domestic market, or it will quickly become a new performance growth point of Innovent Biologics, Innovent Biologics is expected to take the "first east" of Masdotide to turn around, according to the Northeast *** Masdopeptide will achieve 2 billion yuan in revenue in 2025, and China Securities Construction Investment estimates that the sales peak of Masdopeptide is 70About 100 million yuan.
The sword points to the ophthalmology multi-gold circuit
Catch up with the annual sales of $2 billion of single products will be landed
On February 20, Innovent Biologics' Phase 1 registration clinical trial of Ibi311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody injection, in subjects with thyroid eye disease (TED) in China, attracted a lot of attention.
TED is an autoimmune disease that affects the tissues of the eye and is the most common orbital-related disease. Currently, only Horizon Pharma's Tepezza (tetumumab) is approved worldwide for IGF-1R antibodies at the end of 2019. Since its listing, Tepezza's sales have grown rapidly, selling 8$2 billion, and sales in 2022 will double sales, with revenue of 19$6.6 billion. Refinitiv analysis**38% of sales of this product in 2028$500 million.
In order to acquire Tepezza, in October 2023, Amgen spent $27.8 billion to acquire Horizon. According to Amgen's latest financial report for 2023, from the date of the acquisition to December 31, 2023, Tepezza's sales were 4$4.8 billion, judging from Tepezza's sales and major BD situation, TED is a "gold-plus" field.
According to the results of a multicenter, randomized, double-blind placebo-controlled Phase 2 and 3 clinical study of IBI311 to evaluate the efficacy and safety of IBI311 in TED subjects, IBI311 has clinical data comparable to or better than Tepezza.
Innovent said that it will submit a new drug application for IBI311 as soon as possible, and if approved, if approved, IBI311 will not only fill the gap in the domestic TED market, but also have the advantage of being a domestic drug compared to Tepezza, even if Tepezza is also marketed in China. According to relevant reports, a Tepezza's ** is as high as 14,900 US dollars (about 100,000 yuan), and the formal overseas ** channel, its ** is about 150,000 yuan, and from the perspective of efficacy and **, IBI311 has more advantages in China.
In addition, in addition to Innovent Biologics, the products of the three companies that have entered the clinical stage of IGF-1R, Plekang, Zenas (introduced from Viridian), and Minghui Pharmaceutical, are still in the early clinical stage, and they are far from IBI311, so it seems that the "contribution" of IBI311 should not be underestimated.
Other "tinder" should not be underestimated
At present, Innovent has 10 products approved for marketing, including the world's first fully human targeted BCMA CAR-T product, Igta-cel Injection (Focosul), and the first self-developed PCSK9 monoclonal antibody tolecimab injection (Symbila), which will be launched in 2023.
As of the end of 2023, Innovent has more than 30 clinical-stage pipelines in oncology, autoimmunity, metabolic, ophthalmology, and other fields. Among them, 2 varieties of NDA have entered phase III or pivotal clinical studies in the NMPA review, and about 20 new drug varieties have entered clinical studies. On the whole, whether it is a large molecule or a small molecule, Innovent has a layout in most of its layouts, and most of them focus on hot targets, and have entered a virtuous cycle of marketing, clinical and development.
Innovent Biologics Pipeline, **官网.
In the hot ADC field, Innovent has also set foot in two ADCs in its pipeline, namely HER2 ADC IBI 354 and CLAUDIN182 adc ibi343。Recently, Innovent initiated the launch of CBI343 monotherapy**previously received**Claudin 18.".A Phase III G-HOPE-001 study in 2-positive, HER2-negative patients with adenocarcinoma of the stomach or gastroesophageal junction.
As a hot target, cldn182. R&D at home and abroad is in full swing. According to statistics, the domestic CLDN is 182 There are approximately 16 ADC drug types, 12 of which have entered clinical development, and Innovent Biologics' IBI343 is currently making the fastest progress and is a product of great interest in Innovent's pipeline.
In addition, non-oncology pipelines include cardiovascular and metabolic diseases (PCSK9, XOI), autoimmune diseases (IL-23P19, CD40L, OX40L), and ophthalmic diseases (VEGF bispecific antibodies).
Recently, Innovent also released its 2023Q4 results, with Innovent Biologics' total product revenue in 2023 being approximately RMB5.7 billion, compared to 41.1 billion yuan in 20223.9 billion yuan, a year-on-year increase of 37%.
Among domestic innovative drug companies, Innovent Biologics' pipeline is extensive and refined, covering popular tracks such as biosimilars, monoclonal antibodies, bispecific antibodies, ADCs, and CAR-T, and is almost second only to Hengrui Pharmaceutical, the "first brother" with rich pockets.
With the continuous expansion of the commercialization of existing products and new indications, and the continuous breakthrough in the research and development of product candidates, Innovent has reached the stage of multi-point flowering, and it is believed that in the near future, it will be a matter of course to achieve profitability.
References:
Innovent Biologics' official website and financial report.
Innovent Biologics: After the counterattack, open the "volume", and then spread out the "stall", 17talk Yi Qi said.
The strongest ** drug" is coming, Innovent Biologics is making a comeback? Hua Zi Research.
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