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兆科眼科-B(06622)就于印度尼西亚商业化BRIMOCHOL™ PF与PT FERRON订立分销协议
智通财经网· 2025-11-06 09:57
Group 1 - The company has entered into a distribution and supply agreement with PT Ferron Par Pharmaceuticals for the commercialization of BRIMOCHOL™ PF in Indonesia, granting PT Ferron exclusive rights for import, promotion, distribution, marketing, and sales of the product [1] - The company will receive an upfront payment and may earn additional milestone payments based on specific achievements [1] - The developer of BRIMOCHOL™ PF, Tenpoint Therapeutics, announced that the FDA has accepted the new drug application for the product, with a review deadline set for January 28, 2026 [1] Group 2 - BRIMOCHOL™ PF is a preservative-free, experimental eye drop intended to correct near vision loss due to aging, and is part of a multi-center, randomized, double-blind study involving 629 participants across 47 trial centers in the U.S. [2] - The study compares the safety and efficacy of BRIMOCHOL™ PF with other treatments for presbyopia [2] Group 3 - PT Ferron Par Pharmaceuticals, a member of the Dexa Group, has been operating since 2001 and is one of the top 15 largest pharmaceutical companies in Indonesia according to IQVIA data [3] - The company has received recognition from regulatory agencies in the UK and Portugal, enhancing its market influence and operational capabilities through a diverse product portfolio and strong strategic partnerships [3]
LENZ Therapeutics Announces NMPA Submission of New Drug Application for LNZ100 in China for the Treatment of Presbyopia
Globenewswire· 2025-07-28 12:00
Core Insights - LENZ Therapeutics has achieved a significant milestone with the submission of a New Drug Application (NDA) for LNZ100 in China, marking the first regulatory submission outside the United States [1][4] - The NDA submission is backed by positive results from the Phase 3 JX07001 clinical trial, demonstrating significant improvements in near vision for patients with presbyopia [2][4] - Under the License and Collaboration Agreement with CORXEL, LENZ is eligible for up to $95 million in regulatory and sales milestones, along with tiered royalties on net sales in Greater China [3] Company Overview - LENZ Therapeutics is a pre-commercial biopharmaceutical company focused on developing the first aceclidine-based eye drop for improving near vision in presbyopia patients [5] - LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine, targeting a global population of approximately 1.8 billion people affected by presbyopia, including 128 million in the United States [5] - The U.S. FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025, for LNZ100 [5]