Dingxiangyuan Insight: InnoCare Pharmaceutical Co., Ltd. has "shown its sword"
InnoCare Pharmaceutical Co., Ltd. has reached a turning point.
In the first quarter of 2025, InnoCare Pharmaceutical Co., Ltd. achieved total revenue of 381 million yuan, a year-on-year increase of 129.92%, and a net profit of 17.9676 million yuan, successfully turning losses into profits. As of March 31, 2025, InnoCare Pharmaceutical Co., Ltd. held cash and related account balances of approximately 7.78 billion yuan.
Behind this financial report is a survival revelation about innovation, strategy and patience...
The power of big items
The big item is Biotech's "Noah's Ark" through the cold winter, and it is also the clarion call for counterattack.
For example, Betta Pharmaceuticals' icotinib, Ellis's fumetinib, and BeiGene's zanubrutinib are all powerful tools for companies to break through the growth ceiling, vividly explaining the importance of creating hit products.
InnoCare Pharmaceutical Co., Ltd. has been able to deliver outstanding results one after another due to the continued increase in volume of its core single product Orelabrutinib (trade name: InnoCare) and the down payment for the licensing agreement with Prolium. As the first commercial product of InnoCare Pharmaceutical Co., Ltd., orelabrutinib can break out of the highly competitive BTK inhibitor market, and its past market performance is worth digging into.
In 2020, orelabrutinib was approved for marketing in China for the first time for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and relapsed/refractory mantle cell lymphoma (MCL). Relying on the first-mover advantage in the market, Orelabrutinib sold 241 million yuan in 2021.
By 2022, with the inclusion of two indications in the national medical insurance catalog, orelabrutinib's market coverage has expanded, with sales reaching 566 million yuan, a year-on-year increase of 134.85%.
However, due to fierce competition among BTK inhibitors (such as the accelerated penetration of the second-generation BTK inhibitor acotinib), the growth rate of orelabrutinib has slowed down in 2023, with sales only increasing by 18.73% to 670 million yuan.
It was also in this year that orelabrutinib was approved in China for the treatment of patients with marginal zone lymphoma (MZL) who had received at least one previous treatment, becoming the first and only BTK inhibitor approved for MZL indications in China, filling a gap in the market.
After MZL indications were included in medical insurance, Orelabrutinib rapidly increased its volume and ushered in a big explosion in 2024. Sales exceeded the 1 billion yuan mark for the first time, a year-on-year increase of 49.14%, and the strong growth momentum continued into the first quarter of 2025, with sales increasing 89.2% year-on-year to 310 million yuan, contributing more than 80% of InnoCare Pharmaceutical Co., Ltd.'s revenue.
Comparison of sales of BTK inhibitors over the years
Image source: Insight database
Not only that, in April this year, Orelabrutinib also gained a new indication in China (first-line treatment of CLL/SLL patients), and was listed as a Class I recommendation for first-line treatment of CLL/SLL in the "Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines 2025". Compared with the three previously approved second-line treatment indications, Orelabrutinib has greatly broadened the patient population and laid a solid foundation for subsequent rapid expansion.
Orelabrutinib's sales have continued to rise since its launch, not only due to the accumulation of indications, but also due to its differentiated breakthrough strategy. After all, there are many strong players in the BTK inhibitor market, including AbbVie/Johnson & Johnson’s ibrutinib, BeiGene’s zanubrutinib, and AstraZeneca’s acotinib. If you want to break out, differentiation is the best way.
It is precisely thanks to the power of large single products that InnoCare Pharmaceutical Co., Ltd. has achieved a turnaround from losses to profits.
Start a new journey
The ceiling of orelabrutinib is far from reached, and the new journey of InnoCare Pharmaceutical Co., Ltd. has just begun.
At present, Orelabrutinib is "walking on two legs": First, it is to carry out differentiation to the end and expand autoimmune indications; Second, it continues to promote overseas expansion, trying to replicate the successful path of the $2 billion "blockbuster drug" Zanubrutinib in the global market.
Orelabrutinib is the first BTK inhibitor in China to brave the "no man's land" of self-immunity. Currently, it has multiple indications in late clinical stages, including primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS), and primary immune thrombocytopenia (ITP), which are all in phase III; and the treatment of systemic lupus erythematosus (SLE) is in phase IIb clinical trials.
It is worth mentioning that orelabrutinib also has the ability to penetrate the blood-brain barrier and has the potential to exert curative effect on central nervous system diseases and demyelinating diseases at the same time, demonstrating broad-spectrum therapeutic potential.
InnoCare Pharmaceutical Co., Ltd. Autopilot pipeline layout
Image source: Company official website
Going to sea. As early as 2021, InnoCare Pharmaceutical Co., Ltd. reached a licensing cooperation with Biogen for the multiple sclerosis indication of orbrutinib and received an initial payment of US$125 million. But in early 2023, Bogen announced the termination of relevant cooperation.
However, InnoCare Pharmaceutical Co., Ltd. has not given up on promoting orelabrutinib to go overseas and has been conquering the global market.
Currently, in Singapore, orelabrutinib has been approved for the second-line treatment of MCL patients and a marketing application has been submitted for the second-line treatment of MZL patients; in Australia, a marketing application has been submitted for the second-line treatment of MCL patients; in the United States, orelabrutinib is in Phase III clinical stage for the treatment of PPMS and SPMS.
As can be seen from the progress of orelabrutinib, InnoCare Pharmaceutical Co., Ltd. has been actively going overseas.
In January this year, InnoCare Pharmaceutical Co., Ltd., a CD3/CD20 dual antibody ICP-B02 (CM355) developed in collaboration with Connoya, reached a BD cooperation with Prolium with a potential transaction value of more than US$500 million. Under the terms of the agreement, Prolium will acquire the rights to develop, register, manufacture and commercialize ICP-B02 in non-oncology areas globally and in oncology areas outside of Asia.
In the first quarter of 2025, the reason why InnoCare Pharmaceutical Co., Ltd. was able to achieve a year-on-year increase of 129.9% in total revenue to 380 million yuan and successfully turn a profit was not only due to the continued increase in the volume of orelabrutinib, but also the receipt of a down payment from Prolium.
Although InnoCare Pharmaceutical Co., Ltd. currently has fewer overseas transactions, it also has many pipelines with BD expectations in reserve. As InnoCare Pharmaceutical Co., Ltd. stated, "The company will continue to strengthen the globalization of other promising R&D pipelines, and is actively exploring international cooperation and external licensing of important pipelines to expand the company's business cooperation outside the Chinese market."
This also means that InnoCare Pharmaceutical Co., Ltd. has embarked on a new journey, and BD revenue will become the growth engine of the company's performance in the future.
Playing a big game of chess
InnoCare Pharmaceutical Co., Ltd. is making a big move. In addition to expanding its business territory into the fields of autoimmunity and solid tumors, it is also actively promoting BD cooperation.
In fact, as early as 2021, InnoCare Pharmaceutical Co., Ltd. introduced the Greater China rights of the CD19 monoclonal antibody tafasitamab from Incyte.
Currently, tanxituzumab has been approved for marketing in the United States, Europe, and Hong Kong, China, and is expected to be approved in China this year, becoming China's first CD19 monoclonal antibody against diffuse large B-cell lymphoma (DLBCL). After launch, tanxituzumab will form a product combination with orelabrutinib, building InnoCare Pharmaceutical Co., Ltd.'s moat advantage in the field of hematoma. Southwest Securities research report predicts that tanxituzumab is expected to achieve sales of 770 million yuan in 2030.
In addition to "bringing in", InnoCare Pharmaceutical Co., Ltd.'s "going out" is also interesting. InnoCare Pharmaceutical Co., Ltd.’s two TYK2 inhibitors (ICP-332, ICP-488) exhibit high BD potential, Goldman Sachs said in a report.
After all, these two TYK2 inhibitors mainly target autoimmunity, the world's second largest drug market after tumors. The huge number of patients brings huge room for imagination, and as small molecule oral drugs, they have the advantage of convenient administration.
Currently, ICP-332 (soficitinib) has entered clinical phase III for the treatment of atopic dermatitis (AD), and has entered phase II/III for the treatment of vitiligo. ICP-488 has entered phase III for the treatment of psoriasis. The company also plans to develop treatments for autoimmune diseases such as SLE, lupus nephritis (LN), and inflammatory bowel disease (IBD).
InnoCare Pharmaceutical Co., Ltd. Product Pipeline
Image source: Great Wall Securities Research Report
InnoCare Pharmaceutical Co., Ltd.’s self-developed differentiated ADC drug ICP-B794, as well as ICP-248 (mesutoclax), which has attracted much market attention, also has BD expectations.
The B7H3 ADC field where ICP-B794 is located has already produced BD transactions: in December 2023, Hansoh Pharmaceuticals licensed the global rights of HS-20093 outside Greater China to GlaxoSmithKline (GSK) for a potential transaction total of US$1.7 billion.
InnoCare Pharmaceutical Co., Ltd. believes that the company's ADC platform has the potential to become best-in-class. In preclinical studies, ICP-B794 demonstrated potent anti-tumor activity in CDX mouse models of small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and other solid tumors.
In the NCI-H1155 NSCLC CDX model, a head-to-head efficacy comparison of ICP-B794 with the same anti-B7-H3 antibody conjugate from a competing platform showed that a single dose of ICP-B794 of only 0.3 mg/kg can achieve approximately 100% tumor growth inhibition (TGI), which is far superior to the linker-loading of competing platforms.
In addition, the BCL2 inhibitor market where ICP-248 is located has huge market potential: first, the market competition is good, and currently only AbbVie/Roche’s Venetoclax has been approved for marketing in the world; second, Venetoclax’s sales will reach US$2.5 billion in 2024, and peak sales are expected to reach US$6 billion in 2026, which brings huge room for imagination.
ICP-248 is the first BCL2 inhibitor to receive Breakthrough Therapy (BTD) designation in China and has broad commercialization prospects. It is currently conducting a Phase III trial in combination with orbrutinib for the first-line treatment of CLL/SLL, a Phase II single-arm registration trial for r/r MCL patients who have failed previous BTKi treatment, and a monotherapy bridging trial for r/r NHL in the United States and the EU.
Conclusion
The growth path of InnoCare Pharmaceutical Co., Ltd. reveals Biotech’s core logic of crossing the cycle: driving cash flow with large single products and building growth poles with strategic foresight.
InnoCare Pharmaceutical Co., Ltd. did not stop at short-term profits, but instead focused its resources on the field of autoimmunization and global layout, forming a three-wheel drive model of "basic hematology + autoimmunization, new engine of solid tumors + overseas growth". This transformation from a single product to a pipeline matrix, and from the local market to global competition, marks that InnoCare Pharmaceutical Co., Ltd. has entered the value creation stage from the survival stage.
References:
Financial reports, announcements, and official WeChat accounts of each company
Insight database
Great Wall Securities Research Report
Cover source: Zukuhailuo
Disclaimer: This article is for information sharing only and does not represent Insight’s position and views, nor does it recommend or introduce treatment options. If necessary, please consult and contact regular medical institutions.
Editor: Crescent Moon