Innovent Biologics
Innovent Biologics, founded in 2011, is a leading biopharmaceutical company focused on delivering high-quality, affordable biologic therapies. The company recently achieved a significant milestone with regulatory approval in China for Sycume (a teprotumumab biosimilar) to treat thyroid eye disease (TED). This marks the first approval of an IGF-1R monoclonal antibody for TED by China’s National Medical Products Administration (NMPA), representing a potential shift in the standard of care for patients in China and across Asia.
Beyond China, Innovent is expanding globally through strategic collaborations. Its partnership with Roche enabled the international launch of IBI3009, an antibody-drug conjugate (ADC) for small cell lung cancer (SCLC). The company has also strengthened its regional presence by teaming up with Mankind Pharma to bring sintilimab, its anti-cancer immunotherapy, to India.
In China, Innovent continues to make an impact with the approval of mazdutide, an innovative weight-loss therapy, while also maintaining a strong foothold in oncology with sintilimab, one of the country’s leading checkpoint inhibitors. Supported by a large and growing market, rising treatment demand, government investment, and a fully integrated R&D and commercialization platform, Innovent is well-positioned to rapidly scale and deliver innovative, homegrown therapies both domestically and internationally.
“Innovent Biologics, a pioneer in affordable biologics since 2011, is reshaping treatment landscapes with first-in-China approval of Sycume for thyroid eye disease, global collaborations with Roche and Mankind Pharma, and breakthrough therapies like sintilimab and mazdutide—driving innovation across Asia and beyond."
“Takeda’s $1.2 billion collaboration with Innovent Biologics strengthens its oncology pipeline and underscores its commitment to advancing next-generation immuno-oncology and ADC therapies."
Takeda has entered a global license and collaboration agreement with Innovent Biologics (HKEX: 01801) for the development, manufacturing, and commercialization of two late-stage oncology assets — IBI363 and IBI343 — outside of Greater China, with an exclusive option to license IBI3001, an early-stage investigational bispecific ADC.
Under the agreement, Innovent will receive $1.2 billion upfront, including a $100 million equity investment from Takeda, along with potential milestone, royalty, and profit-sharing payments. The collaboration expands Takeda’s oncology pipeline and reinforces its strategic focus on next-generation immuno-oncology and ADC therapies.
IBI 3009
Mechanism of Action: DNA topoisomerase I inhibitors Drug Class: Monoclonal antibodies Originator: Innovent Biologics Indication: Neuroendocrine carcinoma; Small cell lung cancer
This protein is part of the Notch signaling pathway, which is minimally expressed in normal tissues but significantly upregulated in small cell lung cancer (SCLC) and other high-grade neuroendocrine tumors.
Therapeutic Purpose: IBI 3009 is being developed for the treatment of SCLC and neuroendocrine carcinomas. The drug employs Innovent Biologics' proprietary topoisomerase I inhibitor platform for its development.
Current Development: Clinical development of IBI 3009 is ongoing in Australia. The drug aims to provide targeted treatment by attaching a camptothecin derivative topoisomerase I inhibitor payload to the DLL3 protein on cancer cells, thereby inhibiting tumor growth while minimizing effects on normal tissues.
Significance: IBI 3009 represents a cutting-edge approach in anticancer therapy by combining the specificity of antibody-directed conjugation with the potent inhibitory effects on a critical enzyme involved in DNA replication and tumor progression.
IBI 343
Mechanism of Action: DNA topoisomerase I inhibitors Drug Class: Monoclonal antibodies Originator: Innovent Biologics Indication: Adenocarcinoma; Pancreatic cancer
IBI343, a next-generation Claudin 18.2–targeting ADC, has demonstrated promising results in gastric and pancreatic cancers, earning Fast Track designation for advanced pancreatic ductal adenocarcinoma (PDAC). It is in Phase 3 trials for gastric cancer and has completed a Phase 1/2 study in pancreatic cancer. Takeda will fully develop and commercialize IBI343 outside of Greater China.
Claudin18.2 is a highly tissue-specific protein normally found in differentiated epithelial cells of the gastric mucosa but is also overexpressed in various tumors such as gastric, pancreatic, colorectal adenocarcinoma, and ductal adenocarcinoma. IBI 343 leverages this protein by binding to tumor cells expressing Claudin 18.2. This binding triggers an internalization process known as Claudin 18.2-dependent ADC internalization.
Upon lysosomal processing within the cells, the ADC releases an active DNA topoisomerase I inhibitor (TOP1i), which induces DNA damage, leading to apoptosis of the cancer cells. Furthermore, the drug's bystander effect allows it to diffuse through plasma membranes, eliminating neighboring tumor cells. Clinical trials are actively being conducted in Australia, Japan, and China.
IBI 363
Mechanism of Action: Programmed cell death 1 receptor antagonists Drug Class: Bispecific antibodies Originator: Innovent Biologics Indication: Malignant melanoma; Solid tumours
IBI363 is a potentially first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein showing strong activity in multiple solid tumors, including NSCLC and MSS colorectal cancer. It has U.S. FDA Fast Track designation for unresectable or metastatic sqNSCLC post–PD-(L)1 and platinum therapy and is advancing into a global Phase 3 trial. Takeda and Innovent will co-develop and co-commercialize the drug globally with a 60/40 cost and profit split in the U.S., while Takeda will lead commercialization elsewhere.
IBI 3001
Mechanism of Action: Undefined mechanism Drug Class: Bispecific antibodies Originator: Innovent Biologics Indication: Solid tumours
IBI3001, targeting EGFR and B7H3, is in early clinical trials. Takeda holds an option to license its global rights (outside Greater China).
Market revenue of Innovent Biologics
Over the last five years, Innovent Biologics has delivered steady and strong revenue growth, driven by its focus on innovation, product development, and market expansion. This sustained momentum highlights the company’s ability to provide high-quality, affordable biologics addressing critical needs in oncology, immunology, and other therapeutic areas. The commercialization of flagship products, combined with strategic partnerships and regulatory achievements, has significantly strengthened Innovent’s financial performance and reinforced its leadership in China and across Asia.
For the first half of 2025, Innovent reported total revenue of RMB 5.95 billion, marking a 50.6% year-over-year increase. Product revenue reached RMB 5.23 billion, up 37.3% from the previous year. The company also posted notable profit growth, with IFRS net profit rising to RMB 834.3 million and non-IFRS net profit climbing to RMB 1.21 billion.
"Innovent Biologics has sustained strong growth, with H1 2025 revenue up 50.6% year-over-year and profit rising sharply, reinforcing its leadership in innovative biologics."
Six-year market revenue of Innovent Biologics (2020-H12025)
Fig 9: Market revenue of Innovent Biologics
Innovent Biologics: Advancing a Diverse Pipeline Across Key Therapeutic Areas
Innovent Biologics is actively expanding its innovative pipeline, targeting a broad spectrum of therapeutic areas including oncology, autoimmune diseases, metabolic disorders, and ophthalmology. In oncology, the company continues to lead with a strong portfolio of monoclonal antibodies, bispecifics, and antibody-drug conjugates (ADCs), addressing a range of solid tumors and hematologic malignancies. In the autoimmune space, Innovent is developing next-generation immunotherapies aimed at modulating immune responses with higher specificity and fewer side effects. Its metabolic disease pipeline focuses on addressing conditions like diabetes and obesity through novel biologics and combination therapies. Meanwhile, in ophthalmology, Innovent is making strategic strides with innovative treatments designed to address vision-threatening conditions such as diabetic macular edema and thyroid eye disease. This diversified pipeline reflects Innovent’s long-term vision of delivering accessible, high-quality biologic solutions across some of the most challenging and prevalent disease areas globally.
Robust and Diversified Oncology Pipeline Driving Global Innovation
Innovent Biologics’ oncology pipeline demonstrates a robust and diversified portfolio spanning multiple therapeutic modalities, targets, and development stages.
- Broad and Balanced Portfolio: The oncology pipeline covers over 25 candidates, addressing critical cancer targets such as PD-1, VEGF, CD20, FGFR, RET, BCMA, and KRAS G12C. It includes both approved drugs and early-stage investigational assets, ensuring near-term revenue and long-term innovation.
- Strong Marketed Portfolio: Several launched products (e.g., TYVYT® [Sintilimab], BYVASDA® [Bevacizumab], HALPRYZA® [Rituximab], and PEMAZYRE® [Pemigatinib]) anchor the company’s oncology franchise. These approved biologics and small molecules validate Innovent’s R&D and commercialization capabilities.
3. Advanced ADC and Bispecific Expansion: Multiple antibody–drug conjugates (ADCs) — including IBI-343 (CLDN18.2 ADC), IBI-354 (HER2 ADC), and IBI-326 (TROP2 ADC) — are in NDA to Phase I stages. The inclusion of bispecific antibodies (e.g., IBI-363 PD1/IL-2 bispecific) highlights focus on next-generation immune-oncology approaches.
4. Modalities Diversity: The pipeline spans mAbs, ADCs, small molecules, CAR-T therapies, and biologics, providing scientific and commercial flexibility. This diversification mitigates risk and positions Innovent across multiple oncology submarkets.
5. Emerging Biologic Innovation: Novel biologics targeting BCMA, GPRC5D, and CEACAM5 reflect commitment to addressing refractory cancers and evolving therapeutic targets.
6. Global Collaboration Potential: Many assets are partner-ready or globally licensable, demonstrated by Innovent’s strong history of international partnerships.
Diverse and Advancing Pipeline Targeting Key Metabolic Disorders
The image shows a section of a biopharmaceutical pipeline focused on metabolic diseases, highlighting four drug candidates with diverse mechanisms and development stages.
- Broad Target Coverage: The pipeline addresses multiple validated and emerging metabolic targets — PCSK-9, GCG/GIP-1, XOI, and AGT — covering lipid regulation, glucose metabolism, and uric acid pathways.
- Balanced Portfolio: Includes both biologics (e.g., SINTBILO® - Tofolocimib) and small molecules (e.g., IBI-362, IBI-128), showcasing versatility in therapeutic modalities.
- Advanced Clinical Progress: SINTBILO® (Tofolocimib) — Launched, demonstrating proven market success. IBI-362 (Mazdutide) — NDA stage, indicating near-market readiness with strong clinical promise. IBI-128 and IBI-3016 — Phase II and Phase I, ensuring a sustainable pipeline with future growth potential.
- Strategic Focus on High-Value Indications: The inclusion of GLP-1 and dual GCG/GIP agonists positions the company in the fast-growing obesity and diabetes market segment.
Overall, the metabolic pipeline demonstrates scientific depth, modality diversity, and commercial maturity, strengthening the company’s position in the global metabolic disorder therapeutics landscape.
Expanding Immunology Portfolio with Proven and Next-Generation Biologics
Innovent Biologics’ autoimmune pipeline showcases a focused yet strategically diversified portfolio targeting key inflammatory and immune-mediated diseases.
- Strong Foundation with Marketed Product: SULINNO® (Adalimumab), a TNF-α inhibitor, is launched, providing a proven commercial product and market experience in autoimmune therapeutics.
- Advancing Clinical Candidates: IBI-112 (Picankibart), targeting IL-23p19, is at the NDA stage, positioning it as the next potential near-market biologic for conditions like psoriasis and inflammatory bowel disease. This marks Innovent’s progression into next-generation cytokine-targeted therapies.
- Novel Biologic Targets: Early-stage biologics targeting CD40L, OX40L, and IL-4Rα/TSLP (IBI-355, IBI-356, IBI-3002) are in Phase I, reflecting an expansion into advanced immune-modulatory pathways. These targets are relevant in diseases such as asthma, atopic dermatitis, and autoimmune arthritis.
- Diversified Mechanistic Approach: The portfolio balances established pathways (TNF-α, IL- 23) with emerging immunoregulatory mechanisms (OX40L, TSLP), broadening therapeutic reach and innovation potential.
- Strategic Clinical Depth: The combination of marketed, late-stage, and early-stage assets provides both immediate market relevance and long-term growth sustainability in the autoimmune segment.
Advancing Biologic Innovation in Vision and Retinal Disorders
Innovent Biologics’ ophthalmology pipeline showcases a strong and steadily advancing portfolio targeting major vision-related diseases driven by angiogenesis and inflammation.
- Established Market Presence: SYCUME® (Tepotumumab NO1), targeting IGF-IR, is launched, marking Innovent’s entry into the ophthalmology market with a proven monoclonal antibody therapy.
- Advanced Clinical Development: IBI-302, a VEGF/Complement dual-target biologic, is in Phase III, representing a late-stage and differentiated asset aimed at retinal disorders such as age-related macular degeneration (AMD) and diabetic macular edema (DME). Its dual mechanism offers potential for superior efficacy over conventional anti-VEGF therapies.
- Innovative Multi-Target Strategy: Early-phase candidates IBI-324 and IBI-333 target VEGF-A/Ang2 and VEGF-A/VEGF-C, respectively, indicating a multi-pronged approach to overcoming treatment resistance and improving long-term outcomes.
- Diverse Biologic Portfolio: All candidates are biologic-based, aligning with global trends toward high-precision, long-acting ophthalmic treatments.
- Balanced Development Pipeline: The combination of a marketed product, a Phase III late-stage biologic, and two early-phase candidates ensures a healthy development continuum and future growth potential.