China’s Next Wave of Innovation: 10 Breakthrough Drugs to Watch in H2 2026

The 10 breakthrough drugs to watch in H2 2026 in China span a wide range of therapeutic areas, including oncology, rare diseases, cardiovascular diseases, metabolic disorders, and immune-inflammatory conditions. Several of these products have already entered the marketing authorization review or priority review process and could become important additions to China’s innovative drug market.

In 2026, China’s innovative pharmaceutical market continues to show strong momentum. From rare diseases and cancer to cardiovascular and metabolic conditions, a growing number of medicines featuring novel targets, innovative mechanisms, and new drug-delivery approaches are making their way into the Chinese market.

As the second half of the year gets underway, several highly anticipated innovative medicines have already received approval from Chinese regulators, while others remain under marketing application review. These products are expected to remain among the key developments to watch in the Chinese pharmaceutical market in the coming months.

It is important to note that acceptance of a marketing application, inclusion in the priority review process, and regulatory approval are different stages of the drug approval process. Therefore, this article presents these products as key medicines to watch in China during H2 2026, rather than suggesting that all of them are certain to receive approval. Final regulatory decisions should be based on announcements from China’s National Medical Products Administration (NMPA).

10 Innovative Drugs to Watch in H2 2026

Drug	Enterprise	Main Therapeutic Area	Primary Indication	Drug Type / Core Mechanism	China’s Progress as of August 2026
SSGJ‑613 / Amvilitamab	3SBio	Inflammation / Metabolism	Acute Gouty Arthritis	Anti‑IL‑1β Monoclonal Antibody	Approved in August 2026
Etripamil	Milestone Pharmaceuticals / Everest Medicines	Cardiovascular	PSVT (Paroxysmal Supraventricular Tachycardia)	L‑type Calcium Channel Blocker, Nasal Spray	NDA under review
Oveporexton	Takeda	Neurology / Rare Disease	Type 1 Narcolepsy	OX2R Agonist	Approved in July 2026
SHR‑1918	Hengrui Medicine	Metabolism / Cardiovascular	HoFH (Homozygous Familial Hypercholesterolemia)	ANGPTL3 Monoclonal Antibody	NDA accepted and granted priority review
Velitortamab / GR1803	Zhixiang Jintai	Hematologic Oncology	R/R Multiple Myeloma	BCMA/CD3 Bispecific Antibody	Conditional marketing application under review
Iberdomide	BMS	Hematologic Oncology	Multiple Myeloma	CELMoD	NDA under review in China; US accelerated approval granted
Onasemnogene abeparvovec	Novartis	Rare Disease	5q‑associated SMA	AAV‑mediated Gene Therapy	NDA accepted in China
Tinengotinib	Tragen Pharmaceuticals	Oncology	FGFR2‑aberrant Cholangiocarcinoma	Multi‑kinase Inhibitor	NDA accepted
Felzartamab	Biogen	Hematologic Oncology / Immunology	Multiple Myeloma and Others	CD38 Monoclonal Antibody	China’s marketing progress worthy of attention
Fanregratinib	HUTCHMED	Oncology	FGFR2‑positive Intrahepatic Cholangiocarcinoma	FGFR1/2/3 Inhibitor	NDA accepted and granted priority review

1. SSGJ-613: Anti-IL-1β Therapy Brings a New Treatment Option for Acute Gout

Item	Information
Drug	SSGJ-613 / Anflivximab
Company	Sansheng Guojian
Indication	Acute gouty arthritis in adults
Drug Type	Recombinant humanized anti-IL-1β monoclonal antibody
Administration	Subcutaneous injection
China Status	Approved by the NMPA in August 2026
Key Feature	Targets the IL-1β inflammatory pathway

Acute gout attacks are often associated with significant joint pain and inflammation, and IL-1β is an important mediator involved in this inflammatory response. By targeting IL-1β, SSGJ-613 is designed to help control acute gout attacks at the level of the underlying inflammatory pathway.

SSGJ-613 is a humanized anti-IL-1β monoclonal antibody independently developed by Sansheng Guojian. Its marketing application was previously accepted for review, and as of August 2026, the product has received NMPA approval in China under the brand name Yisaina®.

Publicly available Phase III study results showed positive efficacy in relieving acute pain, while also suggesting a potential advantage in helping prevent recurrent acute gout attacks. Its overall safety and tolerability profile was also considered acceptable.

✨ As targeted therapies for inflammatory pathways continue to develop, the approval of Anflivximab represents another development worth watching in the treatment of acute gout. For some patients who need additional treatment options, IL-1β-targeted therapy may offer a new approach to disease management.

2. Etripamil: A Nasal Spray That Could Change the Management of Acute PSVT Episodes

Item	Information
Drug	Etripamil
Company	Milestone Pharmaceuticals / Everest Medicines
Indication	Paroxysmal Supraventricular Tachycardia (PSVT)
Drug Type	L-type calcium channel blocker
Dosage Form	Nasal spray
Key Feature	Rapid onset and patient-administered intranasal treatment
China Status	Marketing application under review

One of the defining characteristics of paroxysmal supraventricular tachycardia (PSVT) is that episodes can occur suddenly. For patients who have already been diagnosed, how to rapidly manage symptoms during an acute episode remains an important aspect of clinical care.

Etripamil is administered as a nasal spray. Compared with traditional approaches that may require treatment in a healthcare setting, one of its key innovations is its potential to offer a more convenient out-of-hospital treatment option.

Results from the Chinese Phase III JX02002 study showed that 40.5% of patients in the etripamil group converted to sinus rhythm within 30 minutes, compared with 15.9% in the placebo group.

The product’s marketing application in China is currently still under regulatory review. In 2026, Everest Medicines further acquired the rights to develop, commercialize, and localize the product in Greater China.

✨ From an innovation perspective, Etripamil is not only a new cardiovascular medicine but also reflects a broader trend toward more convenient and patient-friendly treatment approaches for acute conditions.

3. Oveporexton: One of the Innovative Therapies Targeting the Core Mechanism of Narcolepsy Type 1

Item	Information
Drug	Oveporexton / Aopule‑ton (former name: Aobole‑tong)
Enterprise	Takeda Pharmaceuticals
Indication	Narcolepsy Type 1 in patients aged 16 years and older
Drug Type	Selective OX2R agonist
Core Mechanism	Activates orexin receptor 2
China Status	Approved in July 2026

Oveporexton received marketing approval in China in July 2026 under the official name Aopule‑ton.

Narcolepsy Type 1 is a rare chronic neurological disorder. Patients may suffer from excessive daytime sleepiness, cataplexy, and nocturnal sleep disturbance.

This disease is strongly linked to dysfunction of the orexin system. Oveporexton is an oral orexin receptor 2 (OX2R) agonist. Unlike traditional therapies that mainly control symptoms, its development rationale focuses on the key pathological mechanism underlying the disease.

Findings from two pivotal Phase III studies demonstrated positive outcomes across multiple endpoints, including excessive daytime sleepiness, cataplexy, alertness, daily functioning and quality of life.

✨ This drug achieved the world‑first submission and world‑first approval in China. From NDA submission in January 2026 to approval in July 2026, it serves as a representative case of efficient Chinese drug review and the global‑synchronized R&D model for innovative medicines

4. SHR‑1918: ANGPTL3‑Targeted Agent Enters the Field of Rare Lipid Disorders

Item	Information
Drug	SHR‑1918
Enterprise	Hengrui Medicine
Indication	Homozygous Familial Hypercholesterolemia (HoFH)
Target	ANGPTL3
Drug Type	Fully‑human Monoclonal Antibody
Route of Administration	Subcutaneous Injection
China Status	NDA accepted and granted priority review

Homozygous Familial Hypercholesterolemia (HoFH) is a severe inherited lipid‑metabolism disorder. Patients typically present with extremely high LDL‑C levels and elevated cardiovascular risk, creating sustained clinical demand for innovative lipid‑lowering treatment options.

SHR‑1918 is an innovative lipid‑lowering agent targeting ANGPTL3. According to publicly available clinical data, subcutaneous administration once every four weeks yielded significant reductions in patients’ LDL‑C levels in relevant clinical trials.

✨ ANGPTL3 has emerged as one of the key targets for global lipid‑lowering drug R&D. The potential launch of SHR‑1918 reflects that Chinese innovative pharmaceutical enterprises are accelerating their footprint in innovative therapeutics for metabolic diseases and chronic conditions.

5. Weilitomab: A BCMA/CD3 Bispecific Antibody Continues to Advance Innovation in Multiple Myeloma Treatment

Item	Information
Drug	Weilitomab / GR1803
Company	Zhixiang Jintai
Indication	Relapsed or refractory multiple myeloma
Drug Type	BCMA/CD3 bispecific antibody
Core Mechanism	Redirects T cells to recognize and attack BCMA-positive myeloma cells
China Status	Conditional marketing application under review
Special Progress	Included in the priority review process

Multiple myeloma has become one of the most active areas of innovative drug development in hematologic oncology, with BCMA emerging as one of the most closely watched therapeutic targets.

Weilitomab works by simultaneously targeting BCMA and CD3, helping redirect T cells toward BCMA-positive myeloma cells and enhance their immune-mediated attack.

In publicly reported clinical studies, the drug demonstrated a high objective response rate in patients with relapsed or refractory multiple myeloma, with some patients achieving deep responses.

✨ As CAR-T cell therapies, antibody-drug conjugates, and bispecific antibodies continue to enter the multiple myeloma treatment landscape, therapeutic options are becoming increasingly diverse. Potential approval of Weilitomab could further expand the range of treatment options available for patients with difficult-to-treat disease.

6. Iberdomide: CELMoD Enters a New Stage of Clinical Application

Item	Information
Drug	Iberdomide
Company	Bristol Myers Squibb (BMS)
Indication	Multiple myeloma
Drug Type	CELMoD
Core Mechanism	Cereblon E3 ubiquitin ligase modulation
China Status	Marketing application under review
U.S. Progress	Received FDA accelerated approval in August 2026

Iberdomide belongs to the CELMoD (Cereblon E3 Ligase Modulator) class of novel medicines and represents an important product in BMS’s development of this emerging therapeutic approach.

For general readers, CELMoDs can be viewed as a new generation of medicines developed from the traditional immunomodulatory drug approach, with the potential to improve treatment outcomes when used as part of combination regimens for multiple myeloma.

In a pivotal Phase III study, an Iberdomide-based combination demonstrated positive results in measures including minimal residual disease (MRD) negativity.

✨ From a broader development perspective, multiple myeloma treatment is increasingly moving from individual-drug therapy toward more sophisticated combination strategies. The potential approval of Iberdomide in China could therefore introduce another option for combination treatment and further strengthen the evolving multiple myeloma treatment landscape.

7. Onasemnogene abeparvovec: SMA Gene Therapy Continues to Expand in the Chinese Market

Item	Information
Drug	Onasemnogene abeparvovec
Brand Name	Zolgensma
Company	Novartis
Indication	5q spinal muscular atrophy (SMA)
Drug Type	AAV-based gene therapy
Core Mechanism	Delivers a functional SMN1 gene
China Status	Marketing application accepted

Spinal muscular atrophy (SMA) is a serious inherited rare disease closely associated with abnormalities in the SMN1 gene.

Onasemnogene abeparvovec is one of the representative products in the field of gene therapy. Its core therapeutic approach is to deliver a functional gene to help patients produce the SMN protein needed for motor neuron function.

Unlike conventional treatments that require ongoing administration, gene therapy explores a treatment model with the potential for long-term therapeutic effects. For inherited rare diseases such as SMA, continued advances in this field could have significant clinical implications.

✨ As gene therapy continues to develop in China, products such as Onasemnogene abeparvovec could provide additional treatment options for patients with SMA. At the same time, long-term follow-up, treatment costs, and patient access remain important considerations for the broader adoption of gene therapies.

8. Tinengotinib: Addressing Treatment Needs After FGFR Inhibitor Therapy in Cholangiocarcinoma

Item	Information
Drug	Tinengotinib
Company	TransThera Sciences
Indication	Advanced cholangiocarcinoma with FGFR2 alterations
Drug Type	Multikinase inhibitor
Key Targets	FGFR1–3, JAK1/2, VEGFR, Aurora A/B, and others
China Status	Marketing application accepted
Regulatory Progress	Priority review / Breakthrough Therapy-related designation

Cholangiocarcinoma is a type of cancer for which treatment options remain relatively limited. With the development of molecular testing, an increasing number of patients can be identified with potential therapeutic targets such as FGFR2.

Tinengotinib is a multikinase inhibitor being developed in part for patients whose disease has progressed after previous FGFR inhibitor treatment.

Publicly available clinical data have demonstrated antitumor activity in relevant patient populations.

Clinical Measure	Result
ORR	28.0%
DCR	82.0%
Median PFS	6.1 months
Median OS	20.7 months
Median DoR	8.5 months

One of the key aspects of Tinengotinib is that the development of precision oncology is moving beyond simply identifying a molecular target. Increasing attention is being placed on what treatment options may remain available when patients develop disease progression after targeted therapy.

✨ For patients with FGFR2-altered cholangiocarcinoma, this represents an important area of ongoing innovation and could further expand the treatment landscape if the product receives regulatory approval in China.

9. Felzartamab: Expanding the Potential of CD38-Targeted Therapy

Item	Information
Drug	Felzartamab
Development Code	TJ202 / MOR202
Company	Biogen
Key Target	CD38
Primary Areas	Multiple myeloma and immune-mediated diseases
Drug Type	Human monoclonal antibody
China Rights	Integrated under Biogen in 2026

CD38 has become an important therapeutic target in the treatment of multiple myeloma. Felzartamab is a monoclonal antibody targeting CD38. In addition to its development in multiple myeloma, the drug is also being explored for potential applications in immune-mediated diseases and other indications.

Importantly, drug development is increasingly focused not only on antitumor activity but also on the patient treatment experience, including infusion-related reactions, administration time, and tolerability, particularly among older patients.

✨ If Felzartamab successfully enters the Chinese market, it could further contribute to competition and innovation in CD38-targeted therapies and provide another potential treatment option for patients.

10. Fanregratinib: A Promising Targeted Therapy for FGFR2-Positive Intrahepatic Cholangiocarcinoma

Item	Information
Drug	Fanregratinib
Development Code	HMPL-453
Company	Hutchmed
Indication	FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma
Drug Type	Selective FGFR1/2/3 inhibitor
China Status	Marketing application accepted
Regulatory Progress	Included in priority review

Treatment for intrahepatic cholangiocarcinoma is increasingly moving toward precision medicine. For some patients, molecular testing may identify FGFR2 fusions or rearrangements, which can help determine whether FGFR-targeted therapy should be considered.

Fanregratinib is a targeted therapy developed to inhibit the FGFR pathway. Publicly available Phase II data have demonstrated meaningful disease control and antitumor activity in the relevant patient population.

Key Phase II results include:

Clinical Measure	Result
ORR	42.5%
DCR	83.9%
Median DoR	6.9 months
Median PFS	6.9 months
Median OS	16.6 months
Median Time to Response	1.4 months

Hutchmed announced in December 2025 that the product’s marketing application in China had been accepted and included in the priority review process. Key Phase II data released in 2026 further supported its development potential in patients with FGFR2 fusion/rearrangement-positive intrahepatic cholangiocarcinoma.

✨ For the broader field of precision oncology, Fanregratinib also highlights how molecular testing and targeted treatment are becoming increasingly interconnected, potentially enabling more personalized treatment strategies for patients with specific genomic alterations.

What Changes Are Taking Place in China’s Innovative Drug Market in 2026?

The 10 innovative medicines highlighted in this article show that China’s innovative drug development is continuing to expand into areas such as rare diseases, precision medicine, novel technologies, and improved patient treatment experiences.

1. Innovative Treatments for Rare Diseases Continue to Attract Attention

Among the medicines highlighted in this article are Oveporexton, Novartis’ gene therapy for spinal muscular atrophy, and SHR-1918, which targets conditions including type 1 narcolepsy, spinal muscular atrophy, and homozygous familial hypercholesterolemia (HoFH).

👉 Although these diseases affect relatively small patient populations, they often involve well-defined disease mechanisms and significant unmet medical needs. As a result, developing innovative treatments for rare diseases and specific patient populations has become an important focus for both global pharmaceutical companies and Chinese drug developers.

At the same time, improvements in rare disease diagnosis, evolving drug approval policies, and growing clinical demand are increasing interest in the development and commercialization potential of rare disease medicines.

2. Innovative Treatment Options for Multiple Myeloma Continue to Expand

Based on the products highlighted in this article, multiple myeloma remains one of the more competitive areas of innovative drug development.

Technology / Approach	Representative Drug	Key Feature
Bispecific antibody	Weilitomab	Simultaneously targets BCMA and CD3 to help immune cells recognize and attack tumor cells
Novel immunomodulatory drug	Iberdomide	Uses a protein degradation-related mechanism to exert antitumor activity
Monoclonal antibody	Felzartamab	Targets CD38 and is being further explored in multiple myeloma and immune-mediated diseases

This reflects the increasingly diverse treatment landscape for multiple myeloma, potentially providing patients with more therapeutic options and combination strategies.

3. Precision Oncology Is Becoming More Specialized

Precision medicine has become an important direction in oncology drug development. Tinengotinib and Fanregratinib, for example, highlight this trend in the treatment of cholangiocarcinoma.

Both medicines are associated with abnormalities in the FGFR pathway, with particular attention to cholangiocarcinoma patients who have molecular alterations such as FGFR2 fusions or rearrangements.

In the future, cancer treatment may increasingly follow a more personalized pathway: Disease diagnosis → Molecular testing → Identification of biomarkers → Selection of targeted therapy → Ongoing assessment of treatment response. This means that treatment decisions may depend not only on which type of cancer a patient has but also on the patient’s specific molecular characteristics.

4. Innovation Is Not Limited to New Targets—Drug Delivery Matters Too

In addition to new targets and novel mechanisms, drug delivery and treatment convenience are becoming increasingly important aspects of innovative drug development.

Etripamil is a good example. Compared with traditional approaches that may require acute treatment in a healthcare setting, its nasal spray formulation is designed to provide a more convenient administration option outside the hospital or clinic when appropriate.

This demonstrates that the value of an innovative medicine does not necessarily depend on targeting an entirely new biological pathway.

Overall, the 10 medicines highlighted in this article show that China’s innovative drug market in 2026 is not simply about how many new medicines are approaching market entry. More importantly, innovation is expanding toward more precise, personalized, convenient, and diverse treatment options across a growing range of therapeutic areas.

For the global pharmaceutical market, this also means that China’s innovative drug sector deserves continued attention. As more products move through regulatory review, approval, and commercialization, China’s role in the global pharmaceutical supply chain may continue to grow.

Conclusion

🔬 The 10 breakthrough drugs to watch in H2 2026 offer more than a snapshot of individual medicines. Together, they highlight the rapid evolution of China’s innovative drug market, where domestic pharmaceutical innovation is increasingly developing alongside global therapies.

From monoclonal antibodies and bispecific antibodies to targeted small-molecule therapies and gene therapies, these products demonstrate how Chinese innovative drugs are expanding across rare diseases, oncology, cardiovascular diseases, metabolic disorders, and immune-related conditions.

For the global pharmaceutical industry, China is becoming an increasingly important market for innovative drug development, regulatory approval, and commercialization. As more products move from clinical development to regulatory review and commercialization, international healthcare institutions, pharmaceutical buyers, and specialized pharmacies will have increasing reasons to monitor China new drug approvals and developments in the Chinese pharmaceutical market.

For overseas healthcare institutions, pharmaceutical procurement organizations, and professional pharmacies, staying informed about China’s new drug approvals, Chinese innovative drugs, and China’s pharmaceutical market can help identify emerging products and potential supply opportunities.

DengYuePharmacy continues to follow developments in China’s innovative pharmaceutical market, providing pharmaceutical information, market insights, and professional procurement support for international customers. For customers interested in specialty drug procurement, innovative medicine supply, or access to Chinese pharmaceutical products, explore product information and compliant supply channels and select appropriate services in accordance with local regulations and professional medical advice.

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