Eli Lilly and Co

Gan & Lee Pharmaceuticals announces FDA clearance for GZR18 Injection, a bi-weekly GLP-1 receptor agonist for chronic weight management, to conduct a phase 2 trial against Eli Lilly's Tirzepatide. GZR18 aims to offer flexible treatment options for obese patients, with clinical data showing weight loss effects comparable to or better than existing GLP-1 formulations.

Eli Lilly and EVA Pharma received approval from the Egyptian Drug Authority for their human insulin glargine injection to treat type 1 and type 2 diabetes. The partnership aims to provide affordable insulin to over one million diabetic individuals in low to middle-income countries annually, primarily in Africa. Lilly supplies the active pharmaceutical ingredient at low cost and provides technology transfer to EVA Pharma, enabling local manufacturing. The collaboration also seeks World Health Organization pre-qualification for the insulin injection.

Schrödinger, a computational chemistry company, resists AI hype in drug discovery, emphasizing physics-based methods. CEO Ramy Farid highlights AI's limitations, using it selectively with curated datasets. Schrödinger's approach focuses on molecular interactions, differentiating it from AI-only methods. The company has a successful track record, including cofounded firms and an internal drug pipeline.

Eli Lilly's Alzheimer's treatment Kisunla gains NMPA approval in China, following earlier approvals in the US, Japan, and Great Britain. Kisunla targets amyloid plaques, slowing Alzheimer's progression and reducing plaques by up to 84%, with potential for treatment cessation. Despite side effects like ARIA, Lilly reports a 27% revenue increase.

Cancer trials face a 95% failure rate despite advancements like CAR T-cell therapies. Nuclear isotopes, used for imaging and therapy, show promise in targeting cancer cells while sparing healthy tissues. Actinium-225 and Lutetium-177 are particularly promising, with challenges including supply, delivery precision, and patient-specific dosing. AI could optimize isotope production, delivery, and personalized treatment plans, though data limitations and high costs remain significant hurdles.

FDA approved tapinarof cream 1% for atopic dermatitis in ages 2 and older, representing a non-steroidal option with a new mechanism of action. It improves skin barrier and reduces inflammation, showing a remittive effect. Over 80% of participants aged 2-17 in ADORING 3 trial achieved clear or almost clear skin, with 52% reporting completely clear skin.

2025 will see new obesity treatments, including Eli Lilly's orforglipron and retatrutide, and Amgen's maritide. Researchers will explore GLP-1 agonists for other illnesses. US regulators may approve a non-opioid painkiller, suzetrigine. Trump's potential return as US president could impact science policies, including AI and climate agreements. The WHO aims to finalize a global pandemic treaty by May 2025.

EVA Pharma's insulin glargine injection, produced in collaboration with Eli Lilly, received approval from the Egyptian Drug Authority. This marks the first regulatory approval for EVA Pharma's insulin drug products, aiming to provide affordable insulin to one million people in low- to middle-income countries annually by 2030.

Eli Lilly plans to launch Tirzepatide (Mounjaro) in India by 2025 for treating type 2 diabetes and obesity, competing with Novo Nordisk's Ozempic. The company aims to reflect the drug's efficacy in its Indian pricing strategy. India, known as the diabetes capital, is a key market for Lilly, which is committed to addressing unmet needs with innovative products. Tirzepatide, a dual agonist, may offer greater weight loss benefits than semaglutide, but experts warn against misuse as a cosmetic product.

Eli Lilly's Prevail Therapeutics is evaluating PR001, an AAV9 gene therapy for Parkinson's disease with GBA1 mutations in the PROPEL trial. The open-label, ascending dose study, initiated in 2020, includes one-time PR001 treatment with methylprednisolone and optional sirolimus. The trial, recruiting in the U.S. and Israel, has a 2029 completion date and primary end points include treatment-emergent adverse events and immunogenicity. Additional studies evaluate PR001 for type 2 Gaucher disease.