Simcere Pharmaceutical Secures Multiple Global Licensing Deals, Riding High on Innovation Momentum

Dec 31, 2025 10:10 CST Updated 10:10

Simcere

Innovative Drug Developer

Ipsen

Biopharmaceutical Manufacturer

On December 22, Simcere announced that it had signed an exclusive licensing agreement with Ipsen.Under the terms of the agreement, Ipsen will obtain global exclusive rights for the development, manufacturing, and commercialization of SIM0613, an antibody-drug conjugate (ADC) targeting LRRC15, outside of Greater China. Simcere is entitled to receive up to $1.06 billion, including a $45 million upfront payment, as well as milestone payments related to research and development, regulatory progress, and commercialization, plus tiered sales royalties. SIM0613 is a novel ADC targeting leucine-rich repeat-containing protein 15 (LRRC15), currently in the preclinical stage.

In 2025, Simcere's three multi-antibody and ADC products were successfully licensed one after another, placing the company in the top tier of BD.

As a veteran Pharma, Simcere has performed a textbook transition from imitation to innovation, truly fulfilling its corporate mission of "born for patients."

In the first half of 2025, Simcere achieved an income of 3.585 billion yuan, representing a year-on-year increase of 15.1%. The adjusted net profit reached 650 million yuan, marking a year-on-year growth of 21.1%. The rapid increase in revenue and net profit was driven by the quick market uptake of innovative drugs. On one hand, Xianbixin sublingual tablets were approved for marketing in December 2024, providing sequential treatment with Xianbixin to extend the duration of treatment (DOT) for stroke patients. On the other hand, Enlito (Cetuximab β) and Kesaila (Trilaciclib) were successfully included in the 2024 National Reimbursement Drug List (NRDL) of China, significantly enhancing patient accessibility following expedited access.

As multiple innovative drugs continue to be launched and included in the national medical insurance catalog, the proportion of the company's innovative drugs has been gradually increasing. In the first half of 2025, the proportion of the company's innovative drugs reached 77.4%, an increase of 3.1% compared to 2024. Looking ahead, the proportion of the company’s innovative drugs is expected to continue rising as multiple innovative drug products are gradually rolled out in 2025. In June 2025, **Covexa®** (Daridorexant Hydrochloride Tablets), used for treating insomnia, was approved for marketing by the NMPA and is not regulated as a psychotropic drug. In the same month, **Enzeshu®** (Suvizumab Injection) was also approved for marketing by the NMPA and successfully included in the 2025 National Medical Insurance Catalog, showing promising future growth. As new anti-influenza drug **Mavonosavir** and **Ledakibart** for treating atopic dermatitis had their NDAs accepted by the NMPA in March and July 2025 respectively, the company’s innovative drug pipeline is becoming increasingly robust.

Figure: Simcere's Innovative Drug Revenue Proportion 2020-2025H1

Data Source: Simcere promotional materials

Although the proportion of innovative drugs in Simcere had exceeded 50% to reach 62.3% in 2021, the innovative drugs, mainly including Xianbixin, Endu, and Aidesin, were not recognized by the capital market. For a long time, Simcere was still labeled as a traditional enterprise.

In recent years, with the rise of innovative drug companies such as Akeso Biopharma and RemeGen, there has been a stark contrast between the valuation constraints of generic drugs and the value reevaluation wave for innovative pharmaceutical enterprises. Drugs like ADCs and bispecific/multispecific antibodies are leading the rapid increase in industry valuation.

Based on this, Simcere quickly transformed and invested in the R&D of industry-trend products such as ADC and TCE. Against this backdrop, BD serves as the best endorsement to verify a company's R&D capabilities, especially licensing collaborations with MNCs.

2025 is a critical year for Simcere's innovative R&D to bear fruit, with three innovative products successfully licensed overseas, including two ADC products and one tri-specific antibody product: SIM0500 (CD3/BCMA/GPRC5D), SIM0505 (CDH6-ADC), and SIM0613 (LRRC15 ADC).

（1）SIM0500（CD3/BCMA/GPRC5D）

It is a humanized trispecific antibody targeting GPRC5D/BCMA/CD3, developed by Simcere's proprietary T-cell engager multispecific antibody platform.

In January 2025, Simcere and AbbVie reached a collaboration on the development of SIM0500. According to the terms of the agreement, Simcere Zaiming will receive an upfront payment from AbbVie, as well as optional equity payments and milestone payments totaling up to $1.055 billion. Additionally, Simcere Zaiming will obtain tiered royalties based on the net sales of the product outside the Greater China region.

Efficacy of GPRC5D/BCMA/CD3 Trispecific Antibody in Multiple Myeloma Has Been Validated. Johnson & Johnson's JNJ-79635322 updated its complete Phase I data at the 2025 ASH conference. The data showed that, with a median follow-up of 15 months, the JNJ-79635322 (100mg, Q4W) group achieved an ORR of 100%, a CR rate of 77.8%, and a PFS rate of 96.3% at 12 months among patients (n=27) who had not received prior BCMA/GPRC5D-targeted therapies. In terms of safety, no Grade 3 or higher CRS occurred, and overall safety was manageable. Based on the excellent clinical data, Johnson & Johnson initiated the first Phase III clinical trial (Trilogy-4) of JNJ-79635322 in December.

Figure: Simcere enters into collaboration with AbbVie for SIM0500

Data Source: Simcere promotional materials

（2）SIM0505（CDH6 ADC）

SIM0505 is a novel ADC developed by Simcere Zaiming that targets CDH6 (cadherin-6 or K-cadherin). Its unique binding epitope exhibits higher affinity for tumor antigens compared to similar candidate drugs. SIM0505 utilizes Simcere Zaiming's proprietary TOPO isomerase 1 inhibitor (TOPOi) payload, which demonstrates strong anti-tumor activity while maintaining high systemic clearance, thereby broadening the therapeutic window.

In June 2025, Simcere Zaiming and NextCure reached a strategic cooperation on SIM0505. Simcere received an upfront payment of 15 million US dollars plus milestone payments up to 745 million US dollars, as well as shares of NextCure's listed company; Simcere will also obtain the rights in Greater China for new target ADCs developed based on Zaiming's ADC platform and NextCure’s antibody platform.

CDH6 ADC has been frequently licensed in recent years. In June 2022, OnCusp Therapeutics and Puzhong Discovery reached a licensing agreement for AMT-707. OnCusp Therapeutics obtained the global exclusive rights to develop and commercialize AMT-707 outside of Greater China, while Puzhong Discovery received an upfront payment, milestone payments, and royalties. In October 2023, Merck & Co. and Daiichi Sankyo entered into a global development and commercialization agreement for three ADC candidates from Daiichi Sankyo, including DS-6000 (CDH6 ADC).

Currently, SIM0505 has completed the dosing of the first batch of 5 patients, divided into two dose groups of 1.6 mpk and 3.2 mpk. Early data indicates that partial response (PR) has been achieved in patients in the 1.6 mpk low-dose group, and no interstitial lung disease (ILD) or treatment-related adverse events (TEAE) of grade ≥3 have been observed in the entire cohort so far.

Figure: SIM0505 Phase I Preliminary Clinical Data

Data Source: Simcere promotional materials

（3）SIM0613

It is a novel ADC targeting leucine-rich repeat-containing protein 15 (LRRC15).

In December, Simcere Zaiming and Ipsen reached an exclusive global licensing agreement for SIM0613 outside of Greater China.

LRRC15 is highly expressed in various mesenchymal tumors such as sarcoma, glioblastoma, and melanoma, playing a role in promoting tumor metastasis. In addition, LRRC15 is highly expressed in cancer-associated fibroblasts (CAFs) in multiple tumors, promoting the formation of an immune-excluded and immunosuppressive tumor microenvironment (TME). These characteristics make LRRC15 an attractive target in cancer therapy.

Currently, no LRRC15 ADC has entered the clinical stage globally. Apart from Simcere's SIM0613 successfully partnering with Ipsen, in January 2025, Zai Lab and Alphamab Biologics reached a strategic collaboration to jointly advance the clinical development of ZL-6201 (LRRC15 ADC).

In summary, in recent years, Simcere's innovative transformation has been very successful, with multiple ADCs and drug licenses going overseas, successfully driving the company's stock price to rise rapidly.

Looking at the company's early product pipeline, there are still more than ten multi-specific antibody and ADC products with significant licensing potential, including SIM0237 (PDL1/IL15v), SIM0686 (FGFR2b ADC), SIM0323 (CD80/IL2), etc.

Excellent commercialization capabilities combined with strong R&D strength, looking forward to the company's development reaching new heights.

Source: Pharmaguider

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