On December 15th, Huadong Medicinel (000963) announced that its independently developed ADC innovative drug, Injection HDM2012, has obtained orphan drug qualification recognition (Orphan Drug Designation, ODD) from the US Food and Drug Administration (referred to as "US FDA") for two indications: gastric cancer and gastroesophageal junction cancer, as well as pancreatic cancer. This proves that the innovative nature of its ADC research has been internationally recognized.

Meanwhile, the innovative multi-peptide-based long-acting agonist HDM1005 injection for dual-targeting human GLP-1 (glucagon-like peptide-1) receptor and GIP receptor (glucose-dependent insulinotropic polypeptide), developed by the wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), achieved positive results in the Phase II clinical trial for weight management indications in China.

These two milestones signify a significant leap forward for Huadong Pharmaceutical in the internationalization and cutting-edge exploration of new drug research. They not only demonstrate the company's successful implementation of its research-based philosophy, but also highlight its forward-thinking approach in exploring new targets and formulating research plans, laying the foundation for the company's continued leadership in the innovation field.

HDM2012 has been recognized as an orphan drug.

HDM2012 is the world's first ADC product targeting the MUC-17 site. It is also the only ADC drug known to have entered clinical trials targeting this site. It is composed of an anti-MUC-17 monoclonal antibody and a topoisomerase I inhibitor linked by a cleavable linker. MUC-17 is highly expressed in gastric, colon, and pancreatic cancers, but is expressed minimally in normal organs. Therefore, it is a promising target for ADC development.

The preclinical research results show that HDM2012 has excellent pharmacological properties, safety and efficacy. The data presented by HDM2012 at the 2025 AACR conference indicated that it is a potential therapy for MUC-17 positive gastric cancer, colorectal cancer and pancreatic cancer. The clinical trials of this drug in China and the United States were respectively approved by the National Medical Products Administration and the FDA in July and June 2025, with the indication of advanced malignant tumors.

It is known that orphan drug designation is a kind of qualification recognition granted by the FDA to drugs (including biological products) that are suitable for the prevention, treatment and diagnosis of rare diseases and meet certain conditions. After obtaining orphan drug status, the research and development company is eligible to enjoy various incentive policies.

Huatian Pharmaceutical stated that the two indications of injection HDM2012 for gastric cancer, gastroesophageal junction cancer, and pancreatic cancer, which were granted orphan drug status by the US FDA, represent an important milestone in the development process of this product. This will further enhance the company's core competitiveness in the field of ADC tumor treatment. The injection HDM2012 will have the opportunity to enjoy policy support from the US, including but not limited to: tax credits for clinical trial expenses approved by the FDA, exemption from new drug marketing application fees, and a 7-year market exclusivity after the product is approved for market launch.

The phase II data of dual-target GLP-1 for weight loss is impressive.

HDM1005 injection is a 1st-class chemical new drug independently developed by China-US Huadong Pharmaceutical and possessing global intellectual property rights. It is a long-acting agonist targeting both the human GLP-1 receptor and GIP receptor, and is a peptide-based drug.

Preclinical studies have shown that HDM1005 can activate the GLP-1 receptor and GIP receptor, promote the production of cyclic adenosine monophosphate (cAMP), increase insulin secretion, inhibit appetite, delay gastric emptying, improve metabolic function, thereby improving plasma volume, reducing oxidative stress and systemic inflammation, improving cardiovascular adaptability, and thus has the effects of lowering blood sugar, weight loss, improving metabolic-related steatohepatitis (MASH), and heart failure with preserved ejection fraction (HFpEF).

The HDM1005 injection demonstrated significantly superior therapeutic effects compared to the placebo group. This phase II clinical trial in China was a multicenter, randomized, double-blind, placebo-controlled phase II clinical study evaluating the efficacy and safety of the HDM1005 injection in obese non-diabetic adult subjects. A total of 243 subjects were enrolled, and the treatment period was 22 weeks.

The research data show that after the 4-week titration schedule up to 22 weeks for the HDM1005 injection solution at doses of 0.5mg, 1.0mg, 2.0mg, and 4.0mg, the weight changes compared to the baseline were -7.47%, -9.73%, -13.31%, and -13.28% respectively, which were significantly higher than the -2.46% of the placebo group. The proportion of subjects with a weight reduction of ≥10% in each dose group was 24.0%, 52.1%, 75.0%, and 70.8% respectively, while it was only 6.1% in the placebo group.

It is worth noting that this data is significantly superior to similar GLP-1 dual-target weight loss products. In addition to weight-related indicators, HDM1005 also shows significant improvements in cardiovascular metabolic indicators such as glucose metabolism, blood pressure, and blood lipids, demonstrating good safety and tolerance.

It is reported that Huadong Pharmaceutical is actively advancing the clinical development of HDM1005. The weight management indication was completed with the enrollment of the first subject in the Phase III clinical trial in October 2025, and the Phase II clinical trial for diabetes was completed with the enrollment of all subjects in July 2025. At the same time, the clinical trial applications for HDM1005 in multiple indications such as metabolic-related fatty liver disease (MAFLD) and metabolic-related steatohepatitis (MASH) in China and the United States have been successively approved, demonstrating a systematic layout for indication expansion and marking the full launch of its global clinical development system.
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