Huadong Medicine: China’s Path to Becoming Novo Nordisk in Endocrinology

Chinese version of Novo Nordisk starts to take shape

The Chinese version of Novo Nordisk has subtly taken form. The innovation drug segment of Huadong Medicine is showing strong directional focus in its current layout.

Outside the endocrinology segment, Huadong Medicine has HDM2005, which has strong BD potential, PROTAC drugs in clinical stages, and PD-L1 related fusion proteins.

As for the main focus of the endocrinology segment, Huadong Medicine is clearly making substantial investments. For instance, their three-target pipeline DR10624 recently released impressive Phase I clinical results. This drug is not for weight loss indications, but rather targets differentiated fatty liver indications.

Huadong Medicine's innovation strategy is moving quickly, and the industry is eagerly waiting for the moment when they "defeat the heavens and half the world" and truly become the Chinese version of Novo Nordisk.

Non-Oncology Segment

In the non-oncology segment, Huadong Medicine really doesn't lack imagination.

According to Huadong Medicine's Q1 report this year, their pipeline HDM2005 is an ADC targeting ROR1. This target's ADC is quite familiar to most, being a "hot topic" in the hematological oncology field. Specifically, Merck published the Phase II results of its ROR1 ADC — zilovertamab vedotin, which achieved an impressive 100% complete response (CR) rate in frontline treatment of diffuse large B-cell lymphoma (DLBCL) patients at a dose of 1.75mg/kg.

Additionally, this target has been validated in BD overseas. In February 2025, Shijiazhuang Pharmaceutical's ROR1 ADC successfully secured a BD deal with Radiance Biopharma. Radiance Biopharma paid a $15 million upfront payment, $150 million in development and regulatory milestone payments, $1.075 billion in sales milestone payments, and a certain percentage of sales royalties. The total value of the agreement reached $1.24 billion.

Overall, the initial clinical data for this target is extremely impressive, with low risk, high clinical benefit, and a proven BD precedent. Looking at the large-scale BD experience from last year's TCE bispecific antibody, there is a certain "herd effect" with this target. After one company pioneers BD with a high-certainty target, it triggers follow-up actions from other companies.

Now, for Huadong Medicine's HDM2005 in China, the Phase I clinical trials have completed the first three dose escalations with no dose-limiting toxicity (DLT). Currently, it is in the fourth dose escalation phase while simultaneously entering the expansion phase of the third dose group. Overseas, HDM2005's mantle cell lymphoma (MCL) indication has been granted orphan drug designation by the US FDA. The orphan drug designation overseas adds extra points for BD.

In addition, their three-target fusion protein, DR30206, is another highly imaginative pipeline. It is a fusion protein targeting PD-L1, VEGF, and TGFβ. The dual-target BD deals for the first two targets have been very popular recently, and the addition of TGFβ as a third target is expected to bring better synergistic effects. It is expected that clinical studies for DR30206 in combination with standard chemotherapy will begin in the first half of the year. In terms of indications, it is advancing simultaneously in NSCLC and gastrointestinal cancers, with a bright future in terms of market potential.

Huadong Medicine is also involved in TCE bispecific antibodies. Their pipeline DR30318 targets both CD3 and claudin18.2 and is currently in the IND stage.

Moreover, Huadong Medicine has a PROTAC pipeline. The related pipeline is HDM2006, which targets HPK-1, and its IND application in the US was approved by the FDA in January 2025. Now, everyone is waiting for the preliminary data from Phase I clinical trials to be unblinded.

Weight Loss Field — The Chinese Novo Nordisk

East China Pharmaceutical is not a newcomer in the weight loss field. Its semaglutide has already made a strong debut, initially establishing its position as a domestic leader in endocrinology. Currently, the semaglutide diabetes indication has been submitted for market approval in March 2025 and has been accepted by NMPA. The semaglutide injection for weight management completed the enrollment of all subjects for Phase III clinical trials in February 2025.

Semaglutide is East China Pharmaceutical's key product, and the company is fully committed to making a breakthrough. Of course, current possibilities may lie in future multi-target weight loss drugs.

First, the dual-target approach: HDM1005, targeting the same receptors as tirzepatide, is undergoing Phase II clinical trials. The weight loss indication for this drug completed Phase II subject enrollment in April 2025 and is expected to enter Phase III trials in Q4 of 2025.

Next comes the future of endocrinology — the triple-target approach.

East China Pharmaceutical’s triple-target pipeline, DR10624, has just released its data, making a significant splash. FGF21R is naturally a target for treating liver diseases. This clinical trial used liver fat content (LFC) and fasting triglycerides (TG) as primary clinical endpoints, with changes compared to baseline.

According to the disclosed data, after 12 weeks of treatment, the relative reduction in liver fat content from baseline for each dose group of DR10624 (12.5 mg, 25 mg, 50 mg, and 75 mg dose titration groups) was 51.9%, 77.8%, 79.0%, and 75.8%, respectively, significantly higher than the placebo group, which had a 26.3% reduction. In participants with a baseline liver fat content ≥8%, the relative reductions in LFC from baseline for DR10624’s dose groups were 58.3%, 83%, 89.2%, and 87.2%, respectively, significantly outperforming the placebo group at 27.2%.

Moreover, a relative reduction of 50% in liver fat content is generally considered to likely result in histological remission of fatty liver disease. According to the clinical data, the proportion of participants achieving a relative reduction of ≥50% in liver fat content was 66.7%, 88.9%, 100%, and 85.7% for the 12.5 mg, 25 mg, 50 mg, and 75 mg dose groups, respectively.

In addition to the reduction in liver fat content, DR10624 also showed significant lipid-lowering efficacy. Compared to the placebo group, all DR10624 treatment groups exhibited statistically significant reductions in fasting triglycerides (TG) from baseline. At Week 12, the relative reduction in triglycerides for DR10624’s dose groups was 31.32%, 58.89%, 70.16%, and 55.19%, respectively, while the placebo group only saw a 6.94% reduction.

DR10624 is a first-in-class drug globally, and the data released has naturally attracted significant attention. Will it disrupt the MASH market in the future? It’s definitely worth keeping track of.

Next, there is the triple-target drug DR10627, which targets the same receptors as other triple-target drugs and is also mainly focused on the weight loss field. It is currently in Phase I clinical trials. The period when clinical data is read out will be the golden time for business development (BD), and with the current cost-effectiveness of BD, Novo Nordisk has also chosen BD for a domestic triple-target weight loss drug. As long as the data is solid, the likelihood of BD is very high for this pipeline from East China Pharmaceutical.

Triple-Target Landscape

While East China Pharmaceutical is advancing quickly with its triple-target pipeline, other companies are also catching up, and this field is quietly entering a period of competition.

Shanghai Minwei Biotech’s triple-target agonist MWN109 also targets GLP-1/GIP/GCG. The key differentiator for this drug is that it has an oral version, which is a critical advantage and will greatly improve patient adherence. Currently, most of the triple-target drugs from companies like Eli Lilly are subcutaneous injections. On March 4, 2025, Minwei Biotech’s clinical trial application for the oral tablet of MWN109 was accepted by NMPA. Another fusion protein with the same target, MWN101 injection, has already entered Phase II clinical trials for weight loss and type 2 diabetes indications.

Federation Pharmaceuticals does not need much introduction, as preliminary data shows that its triple-target drug is a “me better” version of Eli Lilly's triple-target, and it has already achieved high-value BD.

On the international front, Hanmi Pharmaceutical is also making progress. Efocipegtrutide (HM15211) is currently being actively developed. It is also an Fc-fusion protein, which means it has long-lasting effects, with a half-life in rats ranging from 82.8 to 85.7 hours. Interestingly, Hanmi is primarily advancing this product not for weight loss, but for MASH (metabolic-associated steatohepatitis). Hanmi is conducting Phase IIb clinical trials (NCT04505436) for the treatment of non-alcoholic steatohepatitis (NASH), which are expected to be completed in May 2025. Additionally, the product has received FDA Fast Track designation for treating non-alcoholic fatty liver disease (NAFLD).

Moreover, Sanofi's SAR441255, although it was initiated early and has been progressing steadily, has not shown any new clinical trial updates recently, and its current status is unclear.

Conclusion

East China Pharmaceutical is not without competitors. Minwei Biotech’s weight loss pipeline is equally impressive, and Astellas Pharma is also a strong contender. Although East China Pharmaceutical is currently massive, growing rapidly, and has enough funding to support R&D, the competition is fierce. To truly become China’s Novo Nordisk, it still has a long road ahead. But as the saying goes, “Though the road is long, the journey will come.”