Respiratory Pipeline Assets
1. SB17170 (Spark Biopharma)
Drug Name(s): SB17170, SBP-401[1][2]
MOA / Modality: HMGB1 protein targeting small molecule
Company: Spark Biopharma
Country: South Korea (US site also operational)
Indication: Idiopathic Pulmonary Fibrosis
Trial Name / NCT ID: SMARTT-004 (NCT06747923)[3]
Trial Details: Phase 2a multicenter, randomized, double-blind, placebo-controlled trial; conducted in South Korea
Notable Results:
No results yet from the trial readout, with only 15 of the 30 targeted patients having been enrolled at the time of the abstract writing. However, primary endpoint completion is estimated for May 2026, meaning a data readout within the next few months is quite possible.[3] The primary endpoint being measured is forced vital capacity (FVC).
2. IBI3002 (Innovent Biologics)
Drug Name(s): IBI3002[4]
MOA / Modality: IL-4Rα and TSLP targeting bi-specific antibody
Company: Innovent Biologics
Country: China
Indication: Mild-to-Moderate Asthma
Trial Name / NCT ID: NCT06213844[5]
Trial Details: Phase 1b double-blind, placebo-controlled study
Notable Results:
No serious AEs were observed in the 8 treated patients. Patients had improved outcomes on measures of airway obstruction (FEV1)[6] and inflammation (FeNO),[7][8] pointing to early signs of clinical efficacy for asthma patients. While a phase 2 trial is not yet announced for asthma, the therapy is underway with a phase 2 for atopic dermatits [22].
3. A93-08 (Jiuzhitang Maker (Beijing) Cell Technology)
Drug Name(s): A93-08[9]
MOA / Modality: Human bone marrow-derived mesenchymal stem cells (hBMMSC)
Company: Jiuzhitang Maker (Beijing) Cell Technology
Country: China
Indication: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Trial Name / NCT ID: NCT06111846[10]
Trial Details: Phase IIa open-label, single-arm trial
Notable Results:
7 of the 10 participants completed evaluations, with no reported TEAEs. Participants exhibited improvements in the oxygen concentration gradient between the lungs and arteries (A-aDO2),[11] indicating greater oxygen transfer to the body's organ systems. This trial is denoted by the authors as the first hBMMSC trial for aPAP.
4. PMG1015 (Pulmongene)
Drug Name(s): PMG1015[12]
MOA / Modality: Amphiregulin (AREG) targeting monoclonal antibody
Company: Pulmongene
Country: China
Indication: Idiopathic Pulmonary Fibrosis (IPF)
Trial Name / NCT ID: Not yet registered
Trial Details: PK/PD modeling study in preparation for a Phase 2b clinical trial
Notable Results:
Pharmacokinetic/pharmacodynamic modeling was conducted to generate the molecular target engagement curve across doses of the therapy to identify the dosage to be used in the planned Phase 2b trial.
The Phase 2b trial was cleared by the FDA in January 2026, but Pulmongene has not yet announced dosing of the first patient.[13] The trial is also not yet registered in ClinicalTrials.gov or in the Chinese Clinical Trials Registry. PMG1015 is Pulmongene's lead asset and is set to proceed rapidly through late clinical stage development, with both FDA Orphan Drug Designation and Fast Track Designation.[14][15][16]
5. INS018_055 (Insilico Medicine)
Drug Name(s): INS018_055, Inhaled Rentosertib[17][18]
MOA / Modality: Small molecule TRAF2- and NCK-interacting kinase (TNIK) inhibitor; inhalable formulation
Company: Insilico Medicine
Country: United States / China (primary HQ in the US; secondary HQ in Hong Kong)
Indication: Idiopathic Pulmonary Fibrosis (IPF)
Trial Name / NCT ID: Not yet registered
Trial Details: Phase 1 randomized, double-blind, placebo-controlled trial; conducted in China
Notable Results:
The abstract outlines the planned trial design for the Phase 1 of inhaled rentosertib in IPF patients in China. The trial is focused on measuring safety, tolerability, and pharmacokinetics.
Up until this point, the clinical efficacy thesis for rentosertib comes from the oral formulation's Phase 2a results (GENESIS-IPF), which included secondary endpoints in forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLCO), and forced expiratory volume in 1 second (FEV1).[19] While not statistically powered and with overlapping 95% confidence intervals, the FVC results for the rentosertib-treated versus placebo groups point to improvements in lung function for IPF patients.
An inhalable formulation of the drug would have notable advantages over the oral form, given more direct delivery to the lung tissue, with implications for more efficient delivery and fewer side and off-target effects.[20]
6. ORJ-001 (Oorja Bio / NIBEC)
Drug Name(s): ORJ-001, NP-201 (former name)
MOA / Modality: β1 integrin agonist peptide
Company: Oorja Bio, NIBEC
Country: United States, South Korea
Indication: Idiopathic Pulmonary Fibrosis (IPF)
Trial Name / NCT ID: Not available
Trial Details: Phase 1 randomized, double-blind trial
Notable Results:
While Oorja Bio (US-based) has been given the global rights to ORJ-001, NIBEC (South Korea-based) was the original developer of the therapy.[21]
Pharmacokinetic and TEAE results were measured, finding no significant deviation from what was observed in preclinical trials. The results of this study enable planning for a Phase 2 trial in IPF.