China’s Pharmaceutical Renaissance: Bispecific Antibodies, Innovation, and Global Impact (2015–2024)

China’s pharmaceutical industry has transformed from a generics-driven market to a global leader in innovative drug development over the past decade, as detailed in Signal Transduction and Targeted Therapy (Tan et al., July 22, 2025) and Nature Reviews Drug Discovery (Hua et al., July 21, 2025) [1,2]. This post synthesizes insights from these sources, alongside analyses of cell and gene therapy (CGT) trends (Liu et al., July 31, 2025), 2024 R&D developments (Chen et al., 2024), and bispecific antibody (BsAb) advancements [3,4,6]. With breakthroughs in BsAbs, CGT, and precision oncology, plus landmark FDA approvals, China is reshaping the global pharmaceutical landscape.

Explosive Growth in Innovative Pipelines

From 2015 to 2024, China’s innovative drug pipeline expanded significantly. Investigational new drug (IND) applications grew from 688 in 2019 to 2,298 in 2023 (35% CAGR), with approvals rising from 627 to 1,918 (32% CAGR) [1]. By December 2024, 4,382 innovative drug candidates initiated first-in-human studies globally, with 3,575 remaining active [2]. The pipeline nearly doubled from 2,251 in 2021 to 4,391 by January 2024, with next-generation biologics—antibody-drug conjugates (ADCs), BsAbs, and cell therapies—rising from 27% to 39% of the share [1].

Oncology dominates (55% of developments), followed by infectious diseases (11%) [1]. In 2024, emerging modalities like targeted protein degraders (TPDs) and small nucleic acids gained traction, reflecting China’s shift toward cutting-edge therapies [4]. Key drug types include:

• Chemical Drugs: 4,821 INDs (2019–2023), with 1,368 in 2023 [1].
• Therapeutic Biologics: 2,350 INDs, led by monoclonal antibodies and CAR-T therapies [1].
• Cell and Gene Therapies (CGT): 765 INDs by June 2025 (553 approved), with CAR-T therapies leading (72 exploratory trials, 9 approvals, including six for hematologic indications and trials for autoimmune diseases like systemic lupus erythematosus) [3,5].

Breakthroughs include Benvitimod Cream (immunology), Surufatinib Capsules (oncology), and BsAbs like IBI-324 (ophthalmology) and CD3/CLDN18.2 (45% ORR in pancreatic cancer) [6].

Bispecific Antibodies: A New Frontier

China’s BsAb sector has surged, with license-out deals totaling $9.26B in H1 2025, surpassing 2024’s $9.15B, driven by a $6.05B 3SBio-Pfizer deal for a PD-1/VEGF BsAb [6]. As PD-(L)1/VEGF matures, companies like Innovent, Hengrui, and SystImmune are pioneering novel combinations:

• Ophthalmology (Ang2/VEGF): IBI-324 (Innovent) shows 4–5x higher VEGF binding affinity than Roche’s faricimab ($4.4B in 2024 sales), with Phase I DME data indicating vision improvement [6]. ASKG712 (Osaikang/Aimu) reported 8.7–10.7 letter BCVA gains [6].
• Hematologic Malignancies (TCEs): CD3/BCMA BsAbs from SystImmune and Keymed secured $2.6B in deals, targeting multiple myeloma [6]. CD3/CD20 candidates show 25% ORR in lupus nephritis [6].
• Solid Tumors: CD3/CLDN18.2 BsAbs (e.g., Qilu Pharma) achieved 45% ORR in pancreatic cancer, while PD-1/LAG3 and EGFR/c-Met combinations advance in gastric and NSCLC [6].

These innovations position China to compete with global leaders like Roche and Amgen, with Phase II/III data driving projected $12B in 2025 deals [6].

Clinical Trials and Financing Surge

Clinical trial registrations exceeded 4,000 in 2023 (26% increase from 2022), with innovative drugs comprising 69% [1]. China’s global trial share reached 12.7%, surpassing Europe in commercially sponsored trials, driven by faster enrollment (2–3x quicker), lower costs ($25,000 per patient for Phase III NSCLC vs. $69,000 in the US), and robust infrastructure [7]. In 2024, investigator-initiated trials (IITs) and multi-regional clinical trials (MRCTs) grew, enhancing global data integration [4].

Financing fueled this growth. From 2015 to 2024, primary market financing events showed significant capital inflow (54.6% disclosure rate), with oncology and ADC pipelines attracting the most funding [2]. In 2024, seed and Series A rounds for CGT and BsAb startups surged [3,6]. Out-licensing deals reached 80 in 2023 ($46.5B total), with H1 2025 seeing 456 transactions worth $130.4B, including 3SBio’s PD-1/VEGF and Hengrui’s $12B GSK deal for HRS-9821 [1,6,8].

Regulatory Reforms Driving Innovation

Regulatory reforms since 2015, led by the National Medical Products Administration (NMPA), have been pivotal. Alignment with ICH guidelines in 2018 introduced a 60-day “silent approval” for trials and priority reviews for unmet needs [1]. The 2019 Drug Regulatory Science Action Plan yielded 337 new tools, while the 2023 “Implementation Plan” and Marketing Authorization Holder (MAH) system empowered R&D [1]. In 2024, the National Drug Centralized Procurement Program and National Reimbursement Drug List (NRDL) negotiations improved market access [2].

For 2025, key reforms include:

• 30-day IND timelines and mandatory eCTD submissions (targeting 130-day priority reviews) [1].
• Expanded real-world evidence (RWE) for rare diseases and oncology [1].
• CGT-specific “One Company, One Policy” tailoring, reducing review times from 260 to 60 days, supported by the Center for Drug Evaluation (CDE) [3,5].

Breakthrough therapy designations rose 43% in 2023 (70 granted), prioritizing oncology and rare diseases [1]. In 2024, anti-“involution” policies curbed me-too drugs, while value-based pricing models enhanced affordability [8].

Global Impact and Challenges

China’s global influence is evident in 2025 FDA approvals, including Sunvozertinib (Dizal) for EGFR exon20 NSCLC, Taletrectinib (AnHeart/Innovent) for ROS1+ NSCLC, and Penpulimab (Akeso) for nasopharyngeal carcinoma, competing with Loqtorzi (Coherus/Junshi, 2023) in immuno-oncology [7]. BsAbs like IBI-324 and CD3/CLDN18.2 further showcase China’s edge in ophthalmology and solid tumors [6]. Challenges persist:

• High CGT IND rejection rates (28%) due to data gaps [3,5].
• Limited MRCTs, hindering FDA/EMA acceptance [1].
• Geopolitical risks driving “NewCo” deal models [1].

Looking Ahead

From 2015 to 2024, China’s pharmaceutical industry has redefined itself as a global innovator, with maturing pipelines in BsAbs, GLP-1 agonists, trispecific engagers, and autoimmune therapies [6,8]. In 2024, CGT and novel modalities like TPDs signal leadership in next-generation therapeutics [3,4]. With $130.4B in H1 2025 deals, China is poised to address global patent cliffs. Stay tuned to SinoDrugWatch for updates.

Sources

[1] Tan, R., Hua, H., Zhou, S., Yang, Z., Yang, C., Huang, G., Zeng, J., & Zhao, J. (2025). Current landscape of innovative drug development and regulatory support in China. Signal Transduction and Targeted Therapy, 10, 220. https://doi.org/10.1038/s41392-025-02267-y
[2] Hua, H., Yang, S., & Zhao, J. (2025). The rise of China’s pharmaceutical industry from 2015–2024: a decade of innovation. Nature Reviews Drug Discovery. https://doi.org/10.1038/d41573-025-00102-1
[3] Liu, Y., et al. (2025). Trends in the development of cellular and gene therapy in China. Nature Reviews Drug Discovery. https://doi.org/10.1038/d41573-025-00126-7
[4] Chen, Z., et al. (2024). Chinese innovative drug R&D trends in 2024. Nature Reviews Drug Discovery, 23, 810–811. https://doi.org/10.1038/d41573-024-00120-5
[5] SinoDrugWatch: China’s CGT Surge. https://www.sinodrugwatch.com/chinas-cgt-surge-unpacking-a-nature-review-on-regulatory-reform-pipeline-trends-global-implications/
[6] SinoDrugWatch: New Frontier of Bispecific Antibody BD in China. https://www.sinodrugwatch.com/new-frontier-of-bispecific-antibody-bd-in-china-after-pd-l-1-vegf/
[7] SinoDrugWatch: FDA Novel Drug Approvals for 2025. https://www.sinodrugwatch.com/fda-novel-drug-approvals-for-2025-precision-therapies-rare-diseases-and-chinas-growing-footprint/
[8] SinoDrugWatch: China Pharma Pulse. https://www.sinodrugwatch.com/china-pharma-pulse-innovation-reform-global-dealmaking-surge/