Several pharmaceutical companies have released favorable updates.
On the evening of December 14, **iHealth Labs Inc.**, a U.S. subsidiary of **Jiuan Medical**, announced that its quadruplex and triplex test kits—including a home-use diagnostic for Influenza A, Influenza B, COVID-19, and RSV—received Premarket Notification (510(k)) clearance from the U.S. FDA.
**Junshi Biosciences** disclosed that its EGFR/HER3 bispecific antibody-drug conjugate (JS212) for advanced solid tumors secured FDA approval for clinical trials. Meanwhile, **InnoCare Pharma** reported that its self-developed BTK inhibitor, orelabrutinib, met primary endpoints in a Phase IIb study for systemic lupus erythematosus (SLE) and gained approval for Phase III registration trials in China. **Yipinhong** announced that its Qinxiang Qingjie Oral Solution was designated a **National Class II Protected Traditional Chinese Medicine**.
### Key Announcements: 1. **Jiuan Medical**: - FDA-cleared products include: - Quadruplex home/professional test kits (Influenza A/B, COVID-19, RSV). - Triplex home/professional test kits (Influenza A/B, COVID-19). - These approvals expand Jiuan’s IVD product line and enhance competitiveness in the U.S. market.
2. **Junshi Biosciences**: - JS212, a bispecific ADC targeting EGFR/HER3, is cleared for late-stage solid tumor trials.
3. **InnoCare Pharma**: - Orelabrutinib is the **first BTK inhibitor** to demonstrate efficacy in SLE Phase II trials. Phase IIa data were presented at EULAR. The drug may become a first-in-class oral SLE treatment.
4. **Yipinhong**: - The TCM protection status strengthens intellectual property rights and market positioning for pediatric medicines. - Its investee, **Arthrosi**, received a $950M upfront offer (+$550M milestones) from **Sobi** for a full acquisition. Yipinhong holds a 13.45% stake via its Hong Kong subsidiary.
### Industry Outlook: 2025 marks a surge in China’s innovation-driven biopharma deals, with Q1-Q3 overseas BD transactions exceeding **$92B** across 103 deals.
**TF Securities** notes that global engagement—via BD, NewCo, or Co-Co models—could unlock significant value, as the global drug market is **6x larger** than China’s.
On December 7, China’s healthcare authorities released the **2025 National Reimbursement Drug List (NRDL)** and the inaugural **Commercial Health Insurance Innovative Drug List**, emphasizing integration between public and private coverage.
**Oriental Securities** highlights: - The commercial insurance list includes **19 drugs** (vs. 121 applicants), with **74% targeting oncology**. - All **5 domestic CAR-T therapies** and **2 Alzheimer’s drugs** were included, signaling recognition of high-value innovations. - Policy tailwinds support revenue acceleration for listed innovators.
**Kaiyuan Securities** adds that dual NRDL/commercial insurance coverage—often at early commercialization stages—will drive rapid growth for innovative therapies, benefiting patients and biopharma firms alike.
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