Soaring 148%! China Medical Achieves Major Breakthrough with 39 Class-1 Innovative Drugs and 12 Poised for Approval
Source: Dengyuemed | September 27, 2025 | Category: Pharmaceuticals
As a Hong Kong drug wholesale distributor, we closely follow China Medical’s progress across innovative drug development, biosimilars, and global expansion.
By tracking these breakthroughs — from first-in-class approvals to Phase III pipelines — we aim to anticipate industry trends and bring timely, high-quality solutions to patients and healthcare partners worldwide.
This year, China Medical has continued to advance its product pipeline: two Class-1 innovative drugs received their first market approvals, two biosimilars submitted NDAs for the first time, and three Class-1 innovative drugs obtained their first clinical trial approvals.
Driven by its dual engines of “Innovation” and “Internationalization,” China Medical now has 57 innovative drugs (including 39 Class-1 drugs) in the domestic clinical application stage or beyond, with 12 of them either having submitted NDAs or in Phase III (including Phase II/III) trials — bringing them closer to commercialization.
A Bumper Harvest: 2 Class-1 Drugs Approved, Insulin Revenue Surges
On August 7, China Medical completed the absorption and merger of its Hong Kong-listed subsidiary, China Medical Changjiang Pharma, and listed on the Hong Kong Stock Exchange Main Board by way of introduction.
This integration has created a closed loop of “R&D – Manufacturing – Sales,” accelerating its global operations.
On August 29, China Medical released its 2025 half-year results, reporting revenue of RMB 1.938 billion. By segment: antiviral drugs contributed RMB 1.412 billion (≈73%), chronic disease treatments RMB 473 million (≈24%), and other products RMB 53 million.
While influenza cases declined compared to last year, impacting oseltamivir demand, China Medical’s flagship brand, Kewei, maintained its leadership position in China’s flu market thanks to its strong brand equity and market penetration.
Insulin products delivered RMB 122 million in revenue, surging 148% year-on-year, underscoring China Medical’s growth potential in chronic disease care.
It’s a Class-1 drug, imitatsvir phosphate capsules, achieved RMB 42.3 million in sales, showing steady performance.
R&D spending reached RMB 348 million in H1 2025, accounting for approximately 18% of total revenue, laying a solid foundation for long-term growth and advancing its innovative pipeline closer to value realization.
This year, China Medical saw two Class-1 innovative drugs win first-time domestic approvals: nathansvir phosphate capsules and acoprevir tablets, jointly used for treating adult patients with genotypes 1, 2, 3, or 6 HCV, either treatment-naïve or interferon-experienced.
This combination represents the only domestically developed, IP-protected, pan-genotypic oral HCV therapy approved in China, cementing the company’s leadership in hepatitis C treatment.
Three Class-1 drugs and one Category 2.2 drug received first clinical approvals, including HEC-007 injection (a GLP-1/GIP/GCG triple agonist) and HEC-301 injection (a GDF15 agonist) for overweight and obesity — with HEC-007 already in Phase I.
HEC20002 capsules, an improved formulation drug, will treat schizophrenia. Two biosimilars — insulin degludec/aspart and insulin degludec injections — submitted NDAs for the first time.
The originators recorded over RMB 1.4 billion and RMB 800 million in sales, respectively, across China’s top three terminal markets in 2024. Four Class-1 drugs and two Category 2.2 drugs submitted INDs, with three Class-1 drugs and one Category 2.2 drug already cleared for clinical trials.
On the generics front, sugammadex sodium injection was approved for production and deemed to have passed consistency evaluation, with sales exceeding RMB 900 million in 2024.
Aclarubicin tablets were filed under the new registration classification; this domestically originated innovative drug has several approved generics, with sales over RMB 1.7 billion in 2024.
39 Class-1 Innovative Drugs in the Pipeline, Targeting Three Major Therapeutic Areas
To date, China Medical has three approved Class-1 innovative drugs — imitatsvir phosphate, nathansvir phosphate, and acoprevir — all for HCV.
In August 2025, it established a dedicated hepatology commercialization team to accelerate market rollout, aiming to capture a potential market peak of RMB 2 billion.
Beyond its commercialized drugs, China Medical has 57 innovative drugs (39 Class-1) under clinical application or beyond, focused on digestive & metabolic diseases, oncology & immunology, systemic anti-infectives, and neurology.
In metabolic diseases, its pipeline covers diabetes, obesity, and NASH. Highlights include the Class-1 drug rogagliflozin glutamate (SGLT2 inhibitor) and two biosimilars (insulin degludec and insulin degludec/aspart), which filed NDAs in January 2024, February 2025, and June 2025, respectively.
HEC96719 tablets and HEC88473 injection are in Phase II, while HEC-007 injection is in Phase I. China Medical is among the leaders domestically in developing FXR agonists, GLP-1/FGF21 dual agonists, and GLP-1/GCG/GIP triple agonists.
In oncology and immunology, the lead candidate is crivonitinib besylate, a second-generation highly selective FLT3 inhibitor, currently in Phase III trials for R/R FLT3-ITD+ AML and in rapid enrollment. Preclinical assets include first-in-class or best-in-class candidates like HEC-921 (a 4-1BB/LY6G6D bispecific antibody for colorectal cancer) and HEC211909 (a potent oral Pan-KRAS inhibitor).
In systemic anti-infectives, the focus is on influenza, HBV, and HCV. Morfesidime mesylate (HBV core protein assembly modulator) is in Phase III.
HECN30227 injection, based on the company’s proprietary siRNA platform, targets both cccDNA- and intDNA-derived HBsAg — potentially shifting the paradigm of HBV treatment and marking China Medical’s entry into nucleic acid therapeutics.
On generics, five products are filed under the new classification, including aclarubicin tablets, vonoprazan fumarate tablets, mirabegron ER tablets, sitagliptin/metformin ER tablets, and fingolimod hydrochloride capsules.
Generics, Insulin, Innovation — Global Expansion Accelerates
Internationally, China Medical has built a global sales network covering eight countries and regions, including the US, Germany, and the UK.
In H1 2025, two generics obtained overseas registrations: rivaroxaban tablets in the US and oseltamivir dry suspension in Germany. China Medical now holds nearly 40 FDA-approved ANDAs across 30+ products.
Its biosimilar insulin glargine injection has been submitted for a US BLA, making China Medical one of only two Chinese firms to do so, with potential approval in H1 2026. It has also filed for Pre-IND consultation with the FDA for insulin aspart.
In November 2024, China Medical signed a licensing deal with Apollo Therapeutics worth up to USD 938 million (including USD 12 million upfront and up to USD 926 million in milestones) for its GLP-1/FGF21 dual agonist HEC88473, granting Apollo exclusive overseas rights.
Looking forward, China Medical plans to:
- Expand global sales of approved products, particularly in the EU and the US.
- Build international capabilities in R&D, regulatory filing, clinical trials, and commercialization, prioritizing assets with clinical value and global competitiveness.
- Strengthen collaborations with multinational pharmaceutical companies to elevate its presence in the global pharmaceutical market.
At Hong Kong DengYue Medicine, we view China Medical’s strong pipeline progress — from Class-1 drug approvals to international expansion — as an important benchmark for the industry. These achievements sharpen our professional insight, enhance our ability to anticipate market needs, and empower us to deliver faster, more effective solutions for patients and partners worldwide.
