As Johnson & Johnson's daratumumab enters the "billion-dollar club" with almost no悬念, the long-awaited CD38 drugs finally showed a prairie fire trend at the beginning of 2025.

In the second week of 2025, the listing and overseas expansion of CD38-targeted drugs brought frequent positive news, becoming one of the key terms at the start of the innovative drug industry.

January 9SanofiAnnounce itsIsatuximab Injection (Sarclisa)®) Approved for Marketing by China's NMPA; January 10,Tianjing BiotechnologyAnnounced the previously introducedCD38 Monoclonal Antibody Injection FizezumabMarketing application approved by the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationAcceptance。

On the same day,Kang NuoyaAnnouncing itsCD38 Monoclonal Antibody CM313InPotential Total Transaction Value of $367.5 MillionAchieving Newco's expansion overseas, and the counterparty company has simultaneously secured funding from multiple internationally renowned investment institutions totaling$180 Million in Financing。

The R&D boom based on the potential of the CD38 target has actually already begun, and the promising prospects of the drug market have been confirmed by the high growth of Johnson & Johnson's daratumumab.

It is reported that, currentlyMore Than a Hundred CD38 Drugs Are Under Research Worldwide, including monoclonal antibodies, bispecific/multispecific antibodies, ADCs, cell therapies, fusion proteins, etc., but only two marketed drugs from Johnson & Johnson and Sanofi.

Among the heavy-weight news that came in succession at the beginning of 2025, the competitive landscape of the CD38 target market will undoubtedly shift from being dominated solely by Johnson & Johnson to a rivalry among N players including Sanofi, Tianjing Biotechnology/Biogen, and Takeda. The battleground will also gradually expand from hematological tumors to autoimmune diseases.

01

The Third Quarter of 2024,Daratumumab(Darzalex/Jylle®)Up 20.7% year-on-yearThe increase contributed to Johnson & Johnson$3.016 billionPerformance,In the first three quarters of 2024, the total sales reached approximately 8.58 billion US dollars, increasing by over 19% year-on-year.

Having reached global sales of $9.74 billion in 2023, representing a year-on-year increase of 22.2%, Evaluate forecastsDaratumumab is expected to achieve a new revenue high of $12 billion in 2024 and reach a peak of over $17 billion by 2028.

As a product that was approved by the U.S. FDA and launched in 2015World's First CD38 Monoclonal AntibodyJohnson & Johnson's Daratumumab performance is seen as a confidence booster for many CD38-targeted drug competitors.

Just approved for marketing in China, fromSanofi's IsatuximabIs one of the most competitive latecomers.

Isatuximab, a drug introduced by Sanofi in 2017, was officially approved for marketing by the U.S. FDA in March 2020, following Johnson & Johnson's daratumumab.The Second CD38-Targeted Drug to be Launched Globally。

Although both drugs are used to treat multiple myeloma, compared to Johnson & Johnson's daratumumab, which has the first-mover advantage and is moving towards its sales peak,Sanofi's Isatuximab is still in the growth phase.The global sales of the drug from 2020 to 2023 are respectively176 million euros, 294 million euros, 381 million euros，In the first half of 2024, it increased by 32% year-on-year to 227 million euros.

Therefore, in addition to continuously expanding its indications, Sanofi is also actively promoting Isatuximab into more markets to capture market share. In 2020, the year it received FDA approval, it was subsequently approved for marketing in the EU and Japan.

In the Chinese market,Daratumumab was approved for marketing as early as 2021 and entered the medical insurance catalog at the cost of a more than 70% price reduction by the end of the same year.

January 9, 2025, four years later,Sanofi IsatuximabOnly just received NMPA approval for marketing in China, but prior to this, it had already becomeOne of the three pilot drugs approved for conducting clinical real-world data research in the Hainan Boao Lecheng International Medical Tourism Pilot Zone.。

In February 2023, Isatuximab was introduced to the Guangdong-Hong Kong-Macao Greater Bay Area under the "Hong Kong-Macao Medicine and Device Access Policy." In December of the same year, its marketing application was submitted to the CDE for the first time and accepted. Finally, at the beginning of 2025, it received marketing approval for use in...In combination with pomalidomide and dexamethasone, Treatment for patients who have received at least one prior line of therapy (including lenalidomide and proteasome inhibitors)Multiple MyelomaAdult patients.

Following Sanofi, Takeda Pharmaceutical from Japan, and China-based Tianjing Biotechnology and Kang Nuoya are among the fastest progressing companies in the field of CD38-targeted drugs.

Among whichTianjing Biotechnology's CD38 Monoclonal Antibody FelzartamabAlso introduced from MorphoSys at the end of 2017, Tianjing Biotechnology (Shanghai) Co., Ltd. holds the exclusive rights for the development and commercialization of this drug across all indications in Greater China (including mainland China, Taiwan, Hong Kong, and Macao).Global rights outside Greater China, after two transfers, at2024Year5MonthlyMNCBiogenSecured.

On January 10, Tianjing Biotechnology announced that the drug had been approved for marketing by the NMPA, also for the treatment of multiple myeloma. Additionally, the primary endpoint of the study is progression-free survival (PFS) for Fizezumab in combination with lenalidomide and dexamethasone.Phase III Registrational Clinical Trial for Second-Line Treatment of Multiple Myeloma (MM)It has been successfully completed so far.

The first domestically produced CD38 antibody to receive clinical trial approval from the National Medical Products Administration (NMPA),CM313, the CD38 monoclonal antibody of Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd., went overseas through NovaBridge Biosciences on January 10., which is considered one of the important signals pushing the track into a booming phase.

This potential $367.5 million Newco deal in 2025 is the first of its kind.Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. received an upfront payment and recent payments totaling US$30 million, while also becoming the largest shareholder of Timberlyne with a 25.79% stake.

Although the upfront payment was not particularly high, it is worth noting that at the same time Timberlyne entered into a CD38 antibody licensing agreement with Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd., Timberlyne obtainedA total of $180 million in financing from several internationally renowned investment institutions。

Specifically includes leading investment byBain Capital Life Sciences Fund, under Rockefeller InvestmentVenrock Health Capital, Carlyle-backedAbingworth, and there are also three co-investors——Boyu Capital, Lilly Asia Ventures, 3H Health Investment. Industry insiders described this as a rare sight—an all-star investment lineup outside of an IPO project.

02

Multiple Myeloma (MM) is the second most common malignant tumor in the hematological system, and as a target highly expressed in these tumor cells, the development potential of CD38 is beyond doubt.

Currently marketed drugs such as Johnson & Johnson's daratumumab, Sanofi's isatuximab, and the soon-to-be-launched tislelizumab from Tianjing Biotechnology/Biogen, all have multiple myeloma as their initial indication, with several extended indications also related to the hematological malignancies field.

But with the deepening of research, the potential of CD38 in the autoimmune field has been continuously uncovered, such asSystemic Lupus Erythematosus (SLE), Light Chain Amyloidosis, Membranous Nephropathy, Primary Immune Thrombocytopenia (ITP)etc.

In addition to the approved first- and second-line treatment indications for multiple myeloma, Johnson & Johnson has also received approval in China for the indication of primary light chain amyloidosis. In their research pipelines, both Johnson & Johnson and Sanofi have directions in autoimmune diseases, such as immune thrombocytopenia and acute myeloid leukemia.

Tianjing Biotechnology/BeiGene's Fazetuzumab Granted FDA Breakthrough Therapy Designation for Treatment in October 2024Late Antibody-Mediated Rejection in Kidney Transplant Patients, which makes fezotinib a promising candidate to becomeThe First Effective Therapy for Advanced AMR。

And except for hematological tumors,Fizezumab is also conducting multiple clinical studies, most of which are focused in the autoimmune field., including primary membranous nephropathy (PMN), antibody-mediated rejection (AMR) after kidney transplantation, and IgA nephropathy, among which Phase II studies for the first two indications have been completed, and the Phase II study for IgA nephropathy is currently ongoing.

Biogen plans to launch Phase III clinical trials for the aforementioned three indications in 2025.

Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd. and Takeda's CD38 monoclonal antibody also include primary immune thrombocytopenia as one of the main research directions.

Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd.'s 20245 semi-annual report shows that its CD38 monoclonal antibody CM313, for the treatment of relapsed/refractory multiple myeloma, lymphoma, and other hematological malignancies in the oncology field, has reached Phase II clinical trials; in the autoimmune field, there are two indications under development, including...Systemic lupus erythematosus is in clinical Phase I, while immune thrombocytopenia is in the clinical trial application stage.。

According to the latest research results of CM313,Its treatment response rate for patients with refractory immune thrombocytopenia is as high as 95%, demonstrating rapid and sustained therapeutic effects with good safety.。

Xinkangjie learned from the CDE official website that Kang Nuoya Biomedical Technology (Chengdu) Co., Ltd.Three clinical trial applications for CM313 were submitted consecutively in October and November 2024., and when announcing the latest Newco deal for CM313 on January 10, 2025, stated that based on the mechanism of action of CD38 and preliminary clinical efficacy results, CM313 is expected to becomeRelapsed/Refractory Multiple Myeloma, Systemic Lupus Erythematosus, and Primary Immune ThrombocytopeniaInnovative treatment options for autoimmune diseases such as ...

TakedaIn July 2022, it submitted its Class 1 new drug targeting CD38, co-developed with Teva, to the CDE.Clinical Trial Application for Modakafusp Alfa Injection (TAK-573) for the Indication of Solid Tumors and Multiple Myeloma (MM).

The latest information from CDE shows that another CD38-targeted drug by Takeda in October 2024Mezagitamab Injection (TAK-079)Obtained a new clinical trial implied permission for useDevelopment of Treatment for Primary Immune Thrombocytopenia (ITP)。

According to the ClinicalTrials website,Takeda has launched the international multicenter Phase III clinical trial of Mezagitamab for the treatment of adult patients with chronic ITP in December 2024.. And inIn China, the product completed a Phase II clinical trial for the treatment of persistent/chronic primary immune thrombocytopenia in March 2024.。

Besides, in ChinaSG301, developed by Shangjian Biotechnology, is the first domestically produced CD38 monoclonal antibody independently researched and developed by a local company in China.In 2021, a clinical trial for SG301 related to hematological tumors has been applied for.In 2023, clinical applications for systemic lupus erythematosus and relapsed/refractory multiple myeloma were successively submitted.。

In mid-June 2024, Shangjian Biotech announced that the first patient had been dosed in the Phase III clinical study of SG301, but the indication is for use in combination with pomalidomide and dexamethasone in relapsed/refractory multiple myeloma.

It is worth mentioning that Shangjian Biotech also has independently developedThe world's first CD38/CD47 bispecific antibody SG2501 received FDA approval for clinical trials in November 2021., for relapsed or refractory malignant hematological tumors, and announced the enrollment of the first subject in a Phase I clinical trial in the United States in August 2022.

In addition, there areSino CellsIn January 2024, the CD38 monoclonal antibody was approved for clinical trials for hematological tumors;Kang Yuan PharmaceuticalsIn May 2024, a Phase I clinical trial of CD38 monoclonal antibody for systemic lupus erythematosus was registered in China.Youzhiyou BioIn August 2020, Y150, a CD38/CD3 bispecific antibody, announced the completion of the first subject dosing in its Phase I clinical trial in China. However, no latest updates have been disclosed so far.

Conclusion

It is reported that Johnson & Johnson's Daratumumab will face a patent cliff in 2026, with its combination patents in the United States, Europe, and Japan expiring in March 2026.

Behind this first near-billion-dollar molecule in the CD38 target area, numerous competitors have gathered. Whether in the field of hematological tumors or autoimmune diseases, the future market competition pattern dominated by one company may no longer exist. In the increasingly important Chinese market, apart from the upcoming battle among multinational giants such as Johnson & Johnson, Sanofi, Biogen, and Takeda, it is also worth looking forward to seeing which company will be the first to launch a domestically produced CD38 drug.

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