Innovent Biologics also disclosed multiple drug collaborations and research and development progress on the eve of the conference. Although it did not disclose a time signal to turn losses into profits, it also stated at the conference that its confidence in achieving a domestic product revenue target of 20 billion yuan by 2027 has become increasingly firm based on the upcoming commercialization of multiple drugs.

On the morning of January 17th, Innovent Biologics announced the disclosure of its newly introduced third-generation EGFR-TKI lung cancer targeted drug, Aoyi Xin ® (Lirotinib tablets) have been approved for marketing by the National Medical Products Administration.

In the early morning of the same day, Yu Dechao, the founder, chairman, and CEO of Innovent Biologics, revealed at the JPM2025 conference that six new drug varieties will be launched in 2025, including three heavyweight products, Masidomide, Pitacizumab, and Tetuximab; We plan to submit new drug applications or critical clinical trials for 7 drugs within the year.

In the popular ADC field, Innovent Biologics has 8 ADC candidate drugs that have entered clinical research, involving popular target tracks such as CLDN 18.2, DLL3, HER3, B7H3, etc., becoming the potential for future international business growth.

After smashing the above positive news before the opening on January 17th, the highest intraday increase of Xinda Biology on that day exceeded 6%. As of the close on January 17th, the stock price of Innovent Biologics increased by 4.83% to HKD 31.45 per share, with a total market value of approximately HKD 51.5 billion.

01. Six new drug varieties are on the market, aiming for 20 billion yuan
In 2022, Innovent Biologics set a goal of achieving a domestic product revenue of 20 billion yuan by 2027.
From the data, the product revenue of Innovent Biologics for the whole year of 2023 was 5.728 billion yuan, a year-on-year increase of 38.4%. In the first three quarters of 2024, it has reached about 6.111 billion yuan, of which about 2.3 billion yuan was in the third quarter, a year-on-year increase of over 40%.

Despite showing a continuous growth trend, the above figures are clearly still far from the target of 20 billion in two years.

Xinkangjie has learned that the new generation ROS1 tyrosine kinase inhibitor (TKI) Daberle, which will be launched in 2024, is included ® (Taretinib Aditate Capsules), Dabert ® (Fluzepril tablets, KRAS G12C inhibitors), as well as the latest blood tumor variety Jeparil introduced from Eli Lilly ® Currently, 14 products of Innovent Biologics have been approved for market, including other products.

Among them, two products have also entered the latest 2024 medical insurance catalog announced at the end of November last year, and are about to usher in more opportunities for volume expansion, including the new drug Xinbeile ® (Toliximab injection), as well as Nivolumab ® A new indication for Orebutinib.

But Xinda Biotech still expresses confidence in achieving its goal of 20 billion yuan, not only because of the continuous increase in the number of products already on the market, but also because of the six new drug varieties that will be launched in 2025.

Xinda Biotech expects to launch three heavyweight drugs by 2025, including:
 Marsdopeptide (GCG/GLP-1): a dual target GLP-1 drug jointly developed by Cinda Biology and Lilly, and the only GLP-1R/GCGR dual agonist that has completed registered clinical research on type 2 diabetes at present. It is expected that weight loss and type 2 diabetes indications will be approved for marketing in the first half of 2025 and the second half of 2025 respectively;
 Tituximab: It is expected to be approved for marketing in the first half of 2025, becoming the first anti-IGF-1R monoclonal antibody to be launched in China for the treatment of thyroid eye disease (TED), and is expected to fill the gap of no new drugs available in this field for 60 years;
 Pikangqibai monoclonal antibody: the first IL-23p19 monoclonal antibody independently developed by a Chinese company, expected to be approved for market by the end of 2025. It is the only IL-23p19 monoclonal antibody in the world with a proportion of more than 80% of subjects achieving PASI 90 (improvement in psoriasis area and severity index ≥ 90%) after 16 weeks of treatment. Its advantages include long-term efficacy maintenance, continued effectiveness even after IL-17 resistance, and quarterly dosing intervals.

In early October last year, Innovent Biologics also introduced Aoyi Xin, the third representative skin growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) targeted drug for lung cancer from Aosai Kang Pharmaceutical ® (Leontinib Tablets) in Chinese Mainland.

On January 17th, Innovent Biologics announced that the drug has been officially approved by the National Medical Products Administration and will soon enter the market.

In addition, Innovent Biologics also revealed that by 2025, it plans to submit new drug applications or key clinical trials for 7 drugs, and launch key registered clinical trials for 7 innovative pipeline projects (based on PoC data), which will provide impetus for its future performance growth.

For example, the world's first PD-1/IL-2 α dual antibody drug IBI363 under Innovent Biologics has obtained positive phase I clinical data in hundreds of core tumor types such as IO resistant lung cancer, melanoma, and IO unresponsive colon cancer. It is expected to be the first to initiate key registered clinical studies on IO resistant advanced melanoma and IO resistant advanced lung squamous cell carcinoma in China by 2025; At the same time, phase II clinical studies are underway in the United States.

02. 8 ADC pipelines open the door to internationalization?
It is reported that Sinovac Biotech's innovative research and development engine, Guoqing Institute, has established a comprehensive technology platform, including ScFv engineering, T cell connector (TCE), VHH bispecific antibody Topo1i ADC、 Innovative technologies such as dual load ADC and antibody peptide conjugates (APCs) efficiently and continuously produce innovative molecules, providing a driving force for the company's long-term development.

At the JPM2025 conference, Innovent Biologics also revealed that as of now, the company has 8 ADC candidate drugs entering clinical research, second only to Yilian Biotechnology (10), Kelubotai (9), and Baili Tianheng (9) in China, and has become one of the "big players" in the global number of clinical ADC products, involving popular target tracks such as CLDN 18.2, DLL3, HER3, B7H3, etc.

It is worth noting that on January 16th, Innovent Biologics announced that its investigational CLDN 18.2 ADC product IBI343 had been included in the list of breakthrough therapeutic drugs (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. The proposed indication is advanced pancreatic ductal adenocarcinoma with CLDN18.2 positive expression that has received at least one systemic treatment.

This is already the second indication for the drug to be included in the breakthrough list by CDE, previously a gastric cancer related indication. In 2024, its indications for pancreatic cancer will also be awarded the fast track qualification by the US FDA.

At this conference, Innovent Biologics also revealed the latest progress of its CLDN 18.2 ADC product IBI343. Currently, it has initiated phase III multi regional clinical trials (MRCT) for gastric cancer in China and Japan; Pancreatic cancer MRCT clinical phase I has read positive efficacy and safety signals in the Chinese population, and has started some clinical enrollment in the United States. It is expected to start international key clinical research after reading PoC validation data in 2025.

This is the fastest progressing product in the ADC pipeline of Xinda Biotech, and also one of the 21 drugs under development with the fastest progress worldwide. Currently, there is no CLDN 18.2 ADC product approved for market.

Another HER2 ADC product under development, IBI354, is also one of Xinda Biotech's rapidly advancing ADC products and is about to undergo phase III clinical trials for platinum resistant ovarian cancer indications.

In addition, on January 2nd, Xinda also reached a global exclusive cooperation license with Roche for its potential best in class DLL3 ADC candidate drug IBI3009, with a total transaction value of over 1 billion US dollars.

The drug is used for advanced small cell lung cancer (SCLC) and has obtained clinical application (IND) approval in Australia, China, and the United States. The first patient in phase I clinical trials was administered in December 2024.

It is reported that among domestic pharmaceutical companies, Hengrui and Zaiding also have similar DLL3 ADC products under development and have entered the clinical stage.

Among other ADC pipelines under development, IBI3009 (DLL3 ADC), IBI3001 (B7-H3/EGFR ADC), and IBI3005 (EGFR/HER3 ADC) are still in the early stages of clinical research.

Today, while domestic innovative pharmaceutical companies are discussing the idea of "getting out of the market without going global", leading innovative pharmaceutical companies such as BeiGene, Kangfang, and Hengrui have all taken steps towards internationalization. However, Xinda Biotech has yet to truly enter the international market.

These ADC pipelines that are continuously advancing and entering global development have been given high hopes by Xinda Biotech to open up international markets and seek incremental development opportunities.

Innovent Biologics stated that as innovative pipelines represented by the new generation of IO (immune oncology) and ADC continue to usher in new opportunities for global development, more innovative ADCs, dual (multi) antibodies, next-generation self immunity, and CVM pipelines will gradually enter global development in the future, opening up upward space for global business.

Conclusion
For 2025, Xinda Biology describes it as a year of gathering momentum and unleashing potential.
As more and more tumor and comprehensive product pipelines begin to commercialize, Innovent Biologics, which has entered the period of realizing its R&D pipeline, is expected to continue to rapidly improve its performance. Innovative molecules with global potential will gradually read out PoC data, and new targets and technological products will enter clinical practice. Innovent Biologics's once bumpy internationalization path may also usher in a new beginning.

Source: https://pharm.jgvogel.cn/c1483317.shtml