In 2026, 82 new drugs are expected to be launched.

Ask AI · How do bispecific antibodies reshape the 2026 cancer treatment landscape?

According to Pharma Intelligence data—the Global Drug Analysis System—China’s market is expected to complete review and approval for 103 new drug registration applications in 2026. Combined with historical data on China’s new drug approval rate of about 80% (see “Major Breakthrough! China’s New Chemical Drug ‘R&D Success Rate’ Released”), it is estimated that 82 new drugs will have the potential to be approved for commercialization throughout the year.

Note: The 103 new drug registration applications covered in this article will reach review conclusions between April and December 2026. The forecast is for reference only and does not represent the actual time of market launch.

01

Multiple blockbuster products, building momentum for launch

Pharma Intelligence data shows that several blockbuster drugs with the potential to be globally first-in-class will be launched in China in 2026. For example, Amgen’s CD3/DLL3 bispecific T-cell engager taralatamab (tarlatamab). The drug received accelerated approval from the U.S. FDA in May 2024 for second-line treatment in adult patients with extensive-stage small cell lung cancer (ES-SCLC). It is the first DLL3-targeting drug approved for commercialization worldwide. Pharma Intelligence data—the Global Drug Analysis System—predicts that it will obtain a review conclusion in July 2026. AstraZeneca’s anifrolumab is the world’s first approved Type I interferon pathway targeted drug for systemic lupus erythematosus (SLE). It brings a brand-new mechanism choice for treating autoimmune diseases; it is predicted to obtain a review conclusion in July this year.

Predicted review conclusion timing for anifrolumab

Image source: Pharma Intelligence data—Global Drug Analysis System

Looking at the application data of pharmaceutical companies whose research and development entities are located in China, locally based pharmaceutical firms have already become the main force behind domestic drug launches in 2026. At the same time, China’s domestic pharmaceutical company landscape has formed a clear split, moving along two distinct innovation development paths.

Traditional leading pharmaceutical companies represented by Innovent Biologics and Hansoh Pharmaceutical rely on deep industrial accumulation to demonstrate strong end-to-end industry-chain deployment and comprehensive R&D capabilities. In areas including oncology, autoimmune diseases, and metabolism, they have multiple breakthroughs—both filing for innovative drugs and building portfolios of improved new drugs.

Meanwhile, a group of innovative Biotech companies is rapidly rising—for example, Concenbio and Alphamab. They are becoming the core innovative force in their respective sub-sectors. Concenbio, leveraging its self-developed bispecific antibody technology platform, has secured a leading position in tumor immunotherapy. Gumokimab (gumokimab) is expected to be approved in China in 2026 for indications including ankylosing spondylitis; Concenbio’s competitor, Alphamab, has been deeply focused on the autoimmune disease track. Alphamab’s new drug registration and application for rusecicartamab (QX002N) has already been accepted by the National Medical Products Administration.

Amid the wave of industry transformation and upgrading, traditional large pharmaceutical companies are strategically shifting toward the innovative drug track. Innovent Biologics is undoubtedly the benchmark company for the most resolute transformation and the most notable implementation results. This round of statistics shows that Innovent Biologics has several innovative drugs expected to be launched in 2026, including the high-selectivity URAT1 inhibitor ruzinurad for gout treatment, and the oral GnRH antagonist SHR-7280 for the assisted reproduction field.

At the same time, multinational pharmaceutical companies (MNCs) in the China market continue to maintain strong development momentum, continuously accelerating the introduction and localization of globally significant innovative products. Companies such as AstraZeneca, Novartis, and GSK are shortening the time gap for global innovative drugs to enter the China market through localized strategies based on global concurrent development.

The China market occupies a pivotal position in the global pharmaceutical industry landscape; therefore, multinational pharmaceutical companies keep increasing their investment and expanding their footprint in China. In January 2026, AstraZeneca officially announced plans to add investments exceeding RMB 100 billion (approximately $15 billion) in the China market before 2030, focusing on deepening its layout in drug manufacturing and R&D within China. Just two months later, AstraZeneca again announced two major projects to be implemented in China. Recently, Novartis also officially announced that it plans to invest more than RMB 3.3 billion in China to launch an expansion of large-scale production and R&D projects.

02

Oncology and autoimmune diseases become hot tracks

Oncology is one of the tracks with relatively dense drug deployments in this round of statistics, with the proportion of products pending launch at about one-third. Cancer is one of the leading causes of death among residents in China, and cancer drug R&D has always been a key focus area in pharmaceutical development.

Based on the data consolidated in this round, domestic oncology drug R&D has moved into a refined stage of targeted therapy. Taking cholangiocarcinoma as an example, FGFR inhibitors have become the R&D focus. Drugs such as tepotinib (替恩戈替尼), sunitinib (他舒替尼), and farnesib citrate (酒石酸凡瑞格拉替尼) have been filed for market launch, providing multiple precise treatment options for patients with cholangiocarcinoma carrying FGFR2 fusions/rearrangements.

The hematologic oncology field is also seeing breakthroughs. Among them, IM19, a CD19-targeted autologous CAR-T cell therapy independently developed by Yimiao Shenzhou, can significantly extend survival in patients with relapsed/refractory diffuse large B-cell lymphoma.

It is worth noting that in the oncology field, two frontier technologies—ADCs and bispecific antibodies—are reshaping the treatment landscape for solid tumors. GSK’s BCMA-targeted ADC drug mabratanutamab is already approved in multiple countries worldwide for treating multiple myeloma. In addition, the HER2-targeted drug anitumab shows excellent clinical potential in two high-incidence cancer types—gastric cancer and breast cancer. The entry of odinotamab further enriches the domestic HER2-targeted pipeline.

The autoimmune disease area is becoming the second major innovative drug track beyond oncology, with competition for IL-4Rα being particularly fierce. Multiple IL-4Rα antibodies—comekibart, rademikibart, SSGJ-611, and others—are simultaneously entering the registration application stage. The target indications are concentrated on atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps, among others. The crowding in this track brings to mind the PD-1 market from years ago.

The IL-17A track is also exceptionally active. Three drugs—gumokimab, roconkibart, and QX002N—are about to launch, with indications concentrated on psoriasis and ankylosing spondylitis. Of note, the lancet (LZM-012) antibody uses an IL-17A/IL-17F dual-target neutralization mechanism, trying to find a breakthrough through differentiation.

Competition among JAK inhibitors shows differentiation between systemic use and local topical use. Pumecitinib (pumecitinib) enters the market in the form of a gel for atopic dermatitis and allergic rhinitis; bonrelitinib (OB756) targets bone marrow fibrosis and polycythemia vera primarily in an oral formulation.

In the metabolism disease field, 2026 presents an innovative landscape where both classic target optimization upgrades and new target mechanism breakthroughs coexist. In addition to classic insulin analogs such as degludec insulin, several innovative drugs targeting sub-sectors within metabolic diseases have appeared prominently. For example, uric disoxycholic acid berberine (HTD1801), developed by Shenzhen Junsun Tai, targets indications including type 2 diabetes and metabolism-related steatohepatitis (MASH). The drug employs a multi-target synergistic mechanism (AMPK activation/NLRP3 inhibition), achieving a new breakthrough in treatment of metabolic diseases.

In the 2026 data, multiple rare disease drugs make an appearance. STSP-0601 is for hemophilia A/B patients with inhibitors, and it has received a designation for breakthrough therapy. Omecaxone sodium, as a rocuronium bromide-specific reversal agent, is expected to address clinical pain points with muscle relaxant antagonism. Cedominqi (sedomingji), as an HGF gene therapy drug, is expected to become a new treatment option for patients with severe lower limb ischemia.

03

Target and technology trends

From the 103 products that are expected to receive review conclusions starting in 2026, the two classic oncology targets—EGFR and HER2—remain consistently high in popularity. These two targets are mainly used for cancer treatment, especially in domestic high-incidence malignancies such as lung cancer and breast cancer.

In addition, the GLP-1R target also has products awaiting launch, including two GLP-1R innovative drugs: Abelanptide from Changshan Pharmaceutical and TG103 from CSPC.

Statistical data also show that target tracks such as IL-4RA and IL-17 have already shown a “research crowding” phenomenon. Taking the IL-4RA track as an example: with the commercialization of dupilumab’s success in global and Chinese markets, domestic pharmaceutical companies are accelerating pipeline layout for this target. A number of same-target drugs—including comekibart and SSGJ-611—have densely applied for market launches. While this clustering of applications fully reflects the maturity of the clinical value of the target and the broad market space, it also intensifies “sector competition” within the track.

What deserves attention is that the R&D technical barriers of newly approved drugs awaiting launch in this round show a clear upward trend. In addition to two traditional mainstream technology routes—monoclonal antibodies and small-molecule inhibitors—frontier technology products such as bispecific antibodies, ADCs, cell therapy (CAR-T), and novel drug delivery route drugs are also clustered in the spotlight.

For example, anitumab injection is a HER2 bispecific antibody with differentiated value. Its registration application covers neoadjuvant treatment for breast cancer and later-line treatment for gastric cancer, demonstrating the ambition of domestic HER2 drugs to expand indications.

Beyond source innovations in targets and technology platforms, formulation improvements and optimization of delivery routes have also become one of the differentiation points in competition. For instance, if it is approved and launched, human insulin enteric capsules (oral insulin) could change the treatment model in which diabetic patients have long relied on injection administration, improving patients’ medication adherence. As for the orodispersible film of mirtazapine hydrochloride (doxepin hydrochloride mouth film), it offers a more convenient delivery option for insomnia patients.

In addition, multiple locally applied topical formulations are expected to obtain review conclusions in China in 2026, or be launched, including pumecitinib gel for atopic dermatitis treatment, eticonazole liniment for tinea unguium treatment, and peinagnena spray for wound infection treatment, among others. By using local administration routes, these drugs significantly improve clinical treatment safety.

04

Conclusion

In 2026, China’s pharmaceutical industry development reaches another critical milestone. This new drug list that will soon receive review conclusions means that a large batch of drugs is about to take root in China. However, launching a new drug is only the first step. How to complete the commercialization closed-loop, how to benefit more patients through Medicare/insurance negotiations, and how to achieve sustainable growth amid fierce market competition—these are questions that every new drug must answer after launch.

References:

1. Pharma Intelligence data—Global Drug Analysis System

2. Official websites of each company

Image source: Photo.com

Statement: This content is for dissemination of industry information only, representing the author’s independent views and not necessarily the position of Pharma Intelligence. If you need to republish it, please be sure to注明 the article author and source.