Breakthroughs Across Multiple Tracks: A Week of Intensive Milestones for China's Class 1 Innovative Drugs

BEIJING — For China's biotech industry, the week of June 16 to 22 may come to be seen as a turning point.

Over seven days, five domestically developed Class 1 innovative drugs — spanning small molecules, bispecific antibodies, antibody-drug conjugates, and AI-designed therapeutics — each crossed a critical milestone: new indications approved, commercial shipments launched, regulatory filings accepted, and clinical trials cleared. The breadth of the advances signaled that years of heavy R&D spending are beginning to pay off.

"These companies have been grinding for a long time," said one industry analyst. "Now the harvest season is here."

AI-Designed Drug Targets Lung Fibrosis

Insilico Medicine held a Phase III investigator meeting in Beijing for rentosertib, an oral treatment for idiopathic pulmonary fibrosis (IPF). The company plans to launch the trial in July. What makes rentosertib unusual is that both its novel target and molecular structure were discovered and designed entirely by artificial intelligence — giving it first-in-class potential.

In September 2024, Phase IIa clinical data showed the drug was well tolerated. Among patients treated for 12 weeks, multiple endpoints — including forced vital capacity (FVC) — improved in a dose-dependent manner, suggesting a potential to reverse disease progression.

ApicHope Pushes Into Gout

On June 18, ApicHope Pharmaceutical Group announced that its subsidiary Guangzhou ApicHope Pharmaceutical had filed a clinical trial application for APH03867 tablets, a novel oral, non-peptide small-molecule URAT1 inhibitor for gout with hyperuricemia. The National Medical Products Administration (NMPA) has accepted the filing.

The drug works by inhibiting URAT1 activity, blocking uric acid reabsorption in renal tubules and increasing uric acid excretion. APH03867 has not been marketed in China or abroad and is classified as a Class 1 chemical innovative drug — the highest tier of novelty under China's regulatory framework.

Northland Clears GMP for Leg-Ulcer Drug

Beijing Northland Biotechnology's sedomin injection (brand name: Huasuoling) passed a GMP compliance inspection by the Beijing Municipal Medical Products Administration on June 16. Its contract manufacturing partner, Jiangsu Yaohai Biopharmaceutical, received a parallel GMP clearance from Jiangsu province.

Sedomin injection is approved for limb ulcers caused by severe lower-limb ischemia — including arteriosclerosis obliterans of the lower extremities, thromboangiitis obliterans, and diabetic lower-limb ischemia — in patients who are not candidates for revascularization surgery or whose surgical outcomes have been inadequate.

Alphamab Ships First HER2 Bispecific Antibody

Alphamab Oncology began its first nationwide commercial shipment of enitotamab (KN026), a HER2 bispecific antibody, on June 16. The drug was approved by the NMPA in May 2025 through the priority review pathway for use in combination with chemotherapy in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing regimen.

The launch marks Alphamab's entry into the commercial stage for its flagship bispecific platform.

Henlius Hits Phase III Endpoint in Eye Disease

Shanghai Henlius Biotech announced on June 16 that its candidate HLX04-O had met the primary endpoint in a Phase III international, multi-center clinical trial (NCT04740671) for wet age-related macular degeneration (wAMD). A New Drug Application for the indication has already been accepted by the NMPA's Center for Drug Evaluation.

wAMD is a leading cause of severe vision loss in adults over 50, and the global market for anti-VEGF therapies exceeds $10 billion annually.

A Broader Pattern

Taken together, the week's developments point to a broader shift: Chinese pharmaceutical companies that have invested heavily in in-house R&D are entering a commercial payoff cycle. At the same time, leading firms are increasingly targeting large-addressable-market indications — from lung fibrosis and gastric cancer to eye disease and gout — where global competition is fiercest and the potential rewards greatest.

The question now is whether this week's cluster of milestones is an outlier or the new normal. If the latter, China's biotech sector may be closer to global parity than many observers realize.