Orelabrutinib’s revenue hits a new milestone! InnoCare Pharma is fully committed to crafting the second growth curve in autoimmune diseases
Jinsong Guo (Founder of DrugTimes)
Founder of DrugTimes（药时代）, Co-President and Secretary General of China Alliance of New Drug Development for Liver Diseases
Overseas interest rate cuts and policy relaxations have brought a chill to the industry which is recovering from Capital Winter, and it’s time to test the real strength of Biotech companies.
On November 11, 2024, InnoCare Pharma disclosed its financial report for the first three quarters, with the company’s revenue increasing by 45.0% year-on-year to 693 million yuan; the gross margin reached 86.0%, an increase of 4.8 percentage points from the same period last year, mainly due to the commercialized product Orelabrutinib .
The overall performance is positive, with impressive quarterly data, and the core product Orelabrutinib has delivered a warm report card: in the third quarter of 2024, it increased by 75.5% year-on-year to 276 million yuan, setting a new record for the highest quarterly revenue since Orelabrutinib was launched. The continuous growth of the core product has significantly narrowed the losses. During the reporting period, the company’s losses narrowed by 47.1% year-on-year to 285 million yuan for the first three quarters of 2024. The company’s R&D expenses increased by 11.9% year-on-year to 615 million yuan for the first three quarters of 2024.
Not only is the loss narrowing, but as an 18A company, InnoCare Pharma’s cash reserves are also a striking advantage. As of September 30, 2024, the company held cash and related account balances of about 7.8 billion yuan.
With ample resources at hand, there is no need to panic. For Biotech companies to cross the “Valley of Death,” sufficient cash reserves are not only a strong support but also help Biotech accelerate global clinical trial development, focus on therapeutic areas, and push high-potential pipelines with FIC (First-in-Class) and BIC (Best-in-Class) potential into later stages.
Malignant tumors and autoimmune diseases are two sides of the same coin. InnoCare Pharma has clearly leveraged its existing pipeline advantages in its pipeline construction. In addition to the hematological tumor indications that are already generating revenue with Orelabrutinib, InnoCare Pharma is expanding Orelabrutinib’s autoimmune disease indications comprehensively, with layout in four autoimmune indications: SLE (Systemic Lupus Erythematosus), MS (Multiple Sclerosis), ITP (Idiopathic Thrombocytopenic Purpura), and NMOSD (Neuromyelitis Optica Spectrum Disorder), and several indications have already entered the later stages.
InnoCare Pharma has good commercial data for its marketed products, and its pipeline planning is advancing according to a predetermined matrix, with a mix of early and later stages and a clear hierarchy. This is a quality that a maturing Biotech company must possess and is essential for Biotech to calmly move against the trend in the continuous cold wind.
Table of Contents
The core product is making good progress, and multiple indications in the autoimmune pipeline have entered the later stages
This year is destined to be a bumper year for Orelabrutinib.
Firstly, in terms of access and commercialization. In December 2023, Orelabrutinib’s new indication was included in the new version of the national medical insurance directory for the treatment of patients with marginal zone lymphoma (MZL) who have previously received at least one treatment. This is a new achievement for Orelabrutinib, which previously had two indications: adult chronic lymphocytic leukemia (r/r CLL)/small lymphocytic lymphoma patients (r/r SLL) who have previously received at least one treatment, and adult mantle cell lymphoma patients (r/r MCL) who have previously received at least one treatment, both of which are already covered by medical insurance.
As the first and only BTK inhibitor approved in China for the MZL indication, after entering the medical insurance directory, Orelabrutinib achieved rapid volume growth in the first half of the year. In the second quarter, Orelabrutinib’s revenue increased by 48.8% year-on-year, and in the third quarter, Orelabrutinib’s revenue increased by 75.5% year-on-year. The growth curve is steep, and it is expected that Orelabrutinib’s sales revenue for the whole year of 2024 will increase by at least 45% compared to 2023.
“How to achieve volume growth for Orelabrutinib” has always been a question from the outside world to InnoCare Pharma. Now it seems that Orelabrutinib has already conquered this city for InnoCare Pharma. On the one hand, Orelabrutinib continues to expand its advantages, and on the other hand, the next milestone is already on the string, and the layout around Orelabrutinib in the field of autoimmune diseases is accelerating.
From past experience, small diseases and small races can be used as tricks to activate the company at critical moments, but at any time, large diseases mean large commercial value and are the biggest moat for the company’s survival. Therefore, after the tumor track, the autoimmune track is a new track for domestic and global pharmaceutical companies, all of which are entering the game and racing forward.
This is because autoimmune diseases can affect almost every organ in the body and can occur at any stage of life. Taking the more familiar SLE (Systemic Lupus Erythematosus) in China as an example, the “China Systemic Lupus Erythematosus Development Report 2020” points out that there are about 1 million SLE patients in China, ranking first in the world in total number, and second in incidence. According to Frost & Sullivan analysis, it is expected that the number of SLE patients worldwide will reach 8.18 million by 2025. The global autoimmune disease market is expected to reach $185 billion by 2029.
InnoCare Pharma has always had a clear plan in the field of autoimmune diseases. The advantage of Orelabrutinib in developing autoimmune indications lies in safety. Autoimmune diseases require long-term medication, and there are higher requirements for safety. Orelabrutinib has higher selectivity, lower toxicity and side effects, and higher bioavailability.
Currently, Orelabrutinib for the treatment of ITP has entered phase III, hoping to break the problem that the BTK target has not yet been successful in the field of autoimmune diseases, and it is expected that patient enrollment will be completed in the first half of next year. Entering autoimmune diseases from hematological tumors into hematology can fully leverage the advantages of the existing hematological tumor commercial team.
In addition to ITP, the phase III global multicenter study of Orelabrutinib for the treatment of primary progressive multiple sclerosis (PPMS) is being launched, and at the same time, the phase III study of SPMS suggested by the FDA is being prepared.
Orelabrutinib is also the first BTK inhibitor to show efficacy in a phase II clinical trial for SLE globally, and it is also a unique small molecule oral drug among the competitors. Starting from the characteristics of Orelabrutinib, InnoCare Pharma can be both offensive and defensive in the field of autoimmune diseases.
New pipeline progress is leading, creating new business growth space
With Orelabrutinib as the horizontal axis of the basic business and autoimmune diseases as the vertical axis of new business, if the expansion of Orelabrutinib in autoimmune diseases demonstrates the strength to strengthen the basic business, then the TYK2 inhibitors (332 and 488) reflect InnoCare Pharma’s courage to break through scientific boundaries.
ICP-332 is a heavyweight oral TYK2 JH1 inhibitor independently developed by InnoCare Pharma, used for the treatment of various T-cell-related autoimmune diseases. TYK2 plays a key role in mediating the signaling of multiple cytokines that cause inflammation, has fewer downstream signaling pathways, and has a safety advantage. It is currently a key development direction for many serious inflammatory and autoimmune diseases.
However, before 2022, TYK2 was relatively unknown, hidden beneath the iceberg. In 2022, Takeda Pharmaceuticals acquired Nimbus’s TYK2 small molecule inhibitor for a $4 billion upfront payment, and the industry began to pay high attention to this target. Many people then discovered its huge commercial prospects. TYK2 is involved in the signaling of various cytokines such as IL-23, IL-12, and Type I IFN, and mediates downstream STAT phosphorylation, bringing a safer and more effective treatment option for autoimmune and inflammatory diseases, which can be widely used for plaque psoriasis, scalp psoriasis, psoriatic arthritis, systemic lupus erythematosus, lupus nephritis, Crohn’s disease, and ulcerative colitis.
InnoCare Pharma has left its mark on this track quite early, and it is a combination punch mark: ICP-332 + ICP-488. The indication for ICP-332 is atopic dermatitis (AD), with 70 million existing AD patients in China; the indication for ICP-488 is psoriasis, with more than 6.5 million incurable psoriasis patients in China.
With such a large patient base and unmet clinical needs, ICP-332 and ICP-488 have become pipelines with great commercial returns. In these two pipelines, InnoCare Pharma is currently leading in development progress, and phase II clinical data have shown the potential of being Best-in-Class.
The phase III clinical trial for ICP-332 in the treatment of AD will be launched in China in the fourth quarter of 2024. The IND application for the second indication, vitiligo, has been accepted, and at the same time, the phase I clinical trial of ICP-332 in the United States has been completed. The phase III clinical trial of ICP-488 is expected to start early next year.
With strong cash on hand, a strong single product that continues to generate blood in the commercial climb, and a high certainty and high growth late-stage pipeline, InnoCare Pharma has all the capital for a Biotech to go through cycles. Good clinical data also lay the foundation for BD, and we have reason to believe that InnoCare Pharma’s growth space remains broad.
All friends are welcome to watch InnoCare Pharma’s 2024 R&D Day !