21. yüzyıla hoş geldiniz. Bugün 12 yaşında olan çocukların e'inin henüz adı bile konmamış mesleklerde çalışacağı söyleniyor.Bu söz nereden. Bu söz Milli Eğitim Bakanlığı'nın yapmış olduğu 21. Yüzyıl öğrenci profili araştırmasında geçen bir söz.Peki sizler bu yüzyıla hazır mısınız ve bu yüzyılın neresindesiniz. Sanki çok yanlış bir zamanda söylenmiş bir söz gibi değil mi. Çünkü 2025 yılındayız.İlk çeyreğini bitirdiğimiz bir yüzyılda bu cümle niye söylendi. Çünkü biz 21. yüzyıl insanı mıyız.Ne yapmalıyız. gib ...

Hepinize merhabalar efendim. Aslında bugün bu sahnede herkesin yapmaya çalıştığı ve hayatımızın her anında ve her yerinde olan iletişimden bahsetmek istiyorum sizlere. Bazen bunu mış gibi yaptığımız, bazen insanların hayatına mış gibi dokunduğumuz iletişim.Ama bu belki çok iyi bir diksiyonla, çok iyi bir telaffuz ettiğiniz bir iletişimden bahsetmek istemiyorum. Çünkü bu çok göreceli bir kavram. Herkese göre, her yöreye göre ya da yaşadığınız, aldığınız eğitime göre değişebilen bir iletişim.Fakat şunu söylem ...

[Müzik] Bir gün bir kral yolun ortasına kocaman bir kaya koyar. Sonra sarayına geçer. İzlemeye başlar.Bakalım der. Bu kayayı yoldan kim kaldıracak. Bir kişi birçok kişi yoldan geçer ama kimse kayayı kaldırmak istemez.Hatta kızarlar. Bu kaya neden burada. O kadar vergi veriyoruz.Bu kayayı kaldıracak gücü yok mu kralın. Derler. Şikayet ederler.Ama kayanın etrafından dolanırlar, giderler. O kayaya dokunmazlar. Sonra bir gün çoban gelir.Çoban kayayı yürür. Aman Allah'ım. Buradan geçen insanların yolunu kapatır. ...

Core Insights - Clearside Biomedical, Inc. is exploring a range of strategic alternatives to enhance its SCS platform and drug development pipeline, aiming to maximize stockholder value [1][2][3] - The company has retained Piper Sandler to assist in the strategic evaluation process, considering options such as asset sales, licensing, collaborations, and mergers [1][2] - Clearside's SCS Microinjector is a validated delivery platform for therapies targeting serious retinal diseases, with five commercial and late-stage development collaborations [1][4][10] Company Highlights - The SCS Microinjector enables a non-surgical, repeatable procedure for targeted delivery of therapies to the macula, retina, and choroid, potentially preserving and improving vision in patients with sight-threatening eye diseases [4][10] - Clearside's lead program, CLS-AX, is in development for the treatment of wet age-related macular degeneration (AMD) and has shown positive Phase 2b clinical data [2][8][10] - The company has successfully navigated the FDA regulatory pathway for its first product, XIPERE, which is approved for suprachoroidal use [8][10] Internal Pipeline - CLS-AX is a proprietary axitinib injectable suspension being developed for wet AMD, with a Phase 3 program planned to maximize its commercial potential [8][10] - The company is also evaluating small molecules for treating geographic atrophy (GA) and diabetic macular edema (DME), addressing high unmet medical needs in retinal diseases [8][10] External Collaborations - Clearside has established partnerships with various companies utilizing its SCS injection platform for other ophthalmic therapeutic innovations, including gene therapies and anti-tumor agents [10][13]

Industry Overview & Trends - The natural transition is increasing, especially with the pandemic, as people are questioning what they consume, wear, and use in cosmetics [7] - Many cosmetic products are being recalled from the market, and ingredients in food are being questioned, highlighting the importance of what we put into our bodies [8] - The use of medicinal and aromatic plants is an ancient practice with significant value in nutrition, food, and healing [8] - There's a growing trend of "do-it-yourself" (DIY) concepts, with people making their own body oils and soaps, reducing harm to the environment [25] - The cosmetic industry is expected to further advance, fully transitioning to edible cosmetics, also known as green, organic, ecological, or natural cosmetics [29] Turkish Market & Endemic Species - Anatolian lands possess incredible biological data and rich resources in edible foods, plants, vegetables, fruits, and medicinal herbs [9][10] - Turkey has over 4,000 endemic species, which are unique to the region and protected [12] - Antalya is rich in endemic species, with 705 endemic species covering the whole world [14] Sustainability & Ethical Practices - Unconscious harvesting leads to the extinction of species, emphasizing the need for education of villagers and collectors [15][16] - Sustainable harvesting practices are crucial for the continuation of species [13][17] - Transitioning to cultivation on large plantations and fields is necessary to prevent species extinction due to incorrect harvesting [26] - Supporting boutique and local producers allows for more transparency and information about the products [33] - Reducing consumption and supporting production, even on a small scale (e.g, growing rosemary or lavender), is essential [35] Applications of Aromatic Plants - Aromatic plants are used in various industries, including food, textiles, perfumery, and chemistry [22] - Essential oils, obtained through distillation, are used in aromatherapy, phytotherapy, fragrances, and cosmetics [20] - Medicinal and aromatic plants are used to create valuable ingredients for well-known perfume brands [21] - Turkey exports significant amounts of thyme, and thyme water can be used as a natural mouthwash [24] - Aromatic plants can be incorporated into daily life for various benefits, such as rosemary tea for focus and peppermint or orange oil for alertness [30][31]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [10][12]. Core Viewpoints - The company, Ailis, is a representative enterprise in the Biotech sector, focusing on innovative cancer drug development, particularly with its core product, Fumetinin, which shows significant clinical data advantages for treating EGFR-sensitive mutation NSCLC [3][6]. - Fumetinin is expected to enhance its market penetration due to its excellent efficacy and safety profile, with sales projected to reach 3.506 billion yuan in 2024, accounting for over 99% of the company's total revenue [7][28]. - The company is expanding its product pipeline through a dual strategy of "self-research + introduction," focusing on high-barrier targets like KRAS G12C and RET, which broadens its growth potential [6][9]. Summary by Sections Company Overview - Ailis has successfully transitioned from a Biotech to a Biopharma company, leveraging the commercial potential of Fumetinin, which was approved for clinical trials in 2016 and launched in 2022 [20][28]. Product and Market Potential - Fumetinin has shown superior efficacy and safety in treating EGFR mutation-positive NSCLC, with ongoing clinical trials aimed at expanding its indications to include brain metastases and rare mutations [7][8]. - The company is collaborating with ArriVent to advance global clinical studies for rare mutations, which could significantly enhance its market presence [8]. Financial Performance - The company reported a revenue of 3.558 billion yuan in 2024, a 76% year-on-year increase, with a net profit of 1.424 billion yuan, reflecting a 121% growth [28][30]. - Revenue forecasts for 2025-2027 are projected at 4.987 billion yuan, 5.768 billion yuan, and 6.896 billion yuan, respectively, with corresponding net profits of 1.737 billion yuan, 2.105 billion yuan, and 2.521 billion yuan [10]. Research and Development - The company maintains a strong focus on innovation, with increasing R&D investments that are expected to remain stable relative to revenue, ensuring a balance between innovation and sustainable growth [32][34].

Core Insights - The company focuses on the field of small molecule innovative drugs, particularly in NSCLC, and possesses both second and third generation ALK-TKIs [1] - The company has a diverse pipeline addressing various cancer indications and urgent clinical needs, including multiple early-stage projects that have achieved significant milestones [1] - The commercial value of the second generation ALK-TKI is about to be realized, and the clinical progress of the third generation ALK-TKI is proceeding smoothly [1] Product Development - SY-707, a second generation ALK-TKI, is under review by NMPA with its NDA accepted in October 2024, and the registration inspection has been completed [2] - SY-3505, the fastest progressing third generation ALK-TKI in clinical trials, shows strong inhibitory effects on key resistant mutations of first and second generation ALK-TKIs [2] - SY-5007, a selective RET-TKI, is currently in phase III clinical trials and has demonstrated good efficacy and safety in patients with RET fusion-positive NSCLC [4] Market Landscape - The ALK-TKI market in China is dominated by second generation products, which are expected to account for 67.33% of the market by 2024, while first generation products are gradually being replaced [3] - Lorlatinib, a third generation ALK-TKI, has rapidly increased its market share since its launch in 2022, projected to reach nearly 15% by 2024 [3] - Alectinib continues to lead the market with a 54.82% share in the hospital sector, while the first generation crizotinib holds a 17.81% market share [3] Financial Projections - The company’s total equity value is estimated at 6.614 billion RMB, with projected revenues of 0.59 billion, 1.43 billion, and 2.87 billion RMB for 2025-2027 [5] - The company is expected to incur net losses of -1.84 billion, -1.71 billion, and -1.74 billion RMB for the same period [5] - Given the imminent launch of SY-707 and the promising clinical progress of SY-3505 and SY-5007, the current market valuation is below the estimated equity value, leading to an "accumulate" rating [5]

Investment Rating - The report assigns an "Accumulate" rating to the company, marking its first coverage [3][8]. Core Insights - The company focuses on the NSCLC small molecule innovative drug sector, possessing both second and third generation ALK-TKIs, with significant advancements in its clinical pipeline [3][17]. - The commercial value of the second generation ALK-TKI is about to be realized, while the third generation ALK-TKI is progressing well in clinical trials [4][60]. - The company has multiple early-stage research projects that have achieved significant milestones, ensuring sustainable development [3][18]. Summary by Sections Section 1: Focus on NSCLC Small Molecule Innovative Drugs - The company specializes in the independent research and development of small molecule innovative drugs, with a pipeline that includes various tumor indications and urgent clinical needs [3][17]. - It is the first domestic company to have both second and third generation ALK-TKIs [3][17]. - As of the 2024 report, the company has 22 proprietary research pipelines, all classified as new drugs [17][18]. Section 2: Commercial Value of ALK-TKIs - The second generation ALK-TKI SY-707 is nearing commercialization, with its NDA accepted by NMPA [4][55]. - The third generation ALK-TKI SY-3505 is the fastest progressing domestic option, with ongoing key clinical trials [4][58]. - The ALK-TKI market in China is dominated by second generation products, which are expected to account for 67.33% of the market by 2024 [60]. Section 3: SY-5007 and RET-TKI Development - SY-5007 is a high-selectivity RET-TKI that is currently in phase III clinical trials, showing promising efficacy and safety [6][22]. - It is the only domestic selective RET-TKI that has entered phase III trials globally, providing a significant competitive edge [6][22]. Section 4: Financial Projections - The company is projected to generate revenues of 0.59 billion, 1.43 billion, and 2.87 billion RMB from 2025 to 2027, with net losses expected to decrease slightly over the same period [7][10]. - The total equity value of the company is estimated at 6.614 billion RMB based on DCF modeling [7][8].

医药生物 2025 年 06 月 15 日 投资评级：看好（维持） 行业走势图 数据来源：聚源 -19% -10% 0% 10% 19% 29% 2024-06 2024-10 2025-02 医药生物 沪深300 相关研究报告 《关注 Protac 自免赛道积极进展—行 业周报》-2025.6.8 《重视Pharma估值重塑的机会—行业 周报》-2025.6.2 《经营拐点显现，动保业务有望贡献 较大业绩弹性，推荐国邦医药—行业 周报》-2025.5.25 SYS6010:广谱抗肿瘤大品种，早期 NSCLC 数据优异 ——行业周报 | 余汝意（分析师） | 余克清（分析师） | 聂媛媛（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | nieyuanyuan@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790124050002 | SYS6010（EGFR ADC）：广谱抗肿瘤大品种，早期 NSCLC 数据优异 截至 2025 年 6 月，全 ...

Enliven Therapeutics (ELVN) Update Summary Company Overview - **Company**: Enliven Therapeutics - **Program**: ELVN001, targeting chronic myeloid leukemia (CML) Industry Context - **Market Size**: CML represents a large market with significant unmet needs, with a potential $9 billion opportunity in the U.S. alone [doc id='45'] - **Current Treatment Landscape**: The treatment of CML has evolved, focusing on quality of life and tolerability, with approximately 30% of patients switching therapies within a year due to intolerance or lack of response [doc id='7'][doc id='8'] Core Points and Arguments 1. **ELVN001's Potential**: ELVN001 is designed to address unmet needs in CML and has shown a potentially best-in-class profile in heavily pretreated patients [doc id='5'][doc id='6'] 2. **Regulatory Pathway**: Historical phase one data in CML has accurately predicted success in pivotal trials, allowing for smaller and faster studies [doc id='5'] 3. **Patient Population**: The ongoing phase one trial has enrolled a heavily pretreated population, with 72% of patients having discontinued their last TKI due to lack of efficacy [doc id='20] 4. **Efficacy Results**: - 47% of patients achieved major molecular response (MMR) by 24 weeks, with 32% achieving MMR and 100% maintaining MMR [doc id='24'] - 77% of patients achieved MR2 by 24 weeks, indicating robust efficacy despite the heavily pretreated population [doc id='25] 5. **Comparison with Osiminib**: ELVN001's efficacy appears favorable compared to osiminib, with a higher MMR rate in a more heavily pretreated population [doc id='27][doc id='36'] 6. **Safety Profile**: ELVN001 has shown a favorable safety profile, with low rates of dose reductions and discontinuations due to adverse events [doc id='31][doc id='34] 7. **Dosing Convenience**: ELVN001 supports once-daily dosing with or without food, addressing key challenges with current TKIs [doc id='34][doc id='77] Additional Important Insights - **Market Dynamics**: The CML market supports multiple blockbuster drugs despite the presence of generics, with TKI switching dynamics indicating a need for better treatment options [doc id='12] - **Emerging Competition**: Osiminib has rapidly penetrated earlier lines of therapy, but high discontinuation rates (50% within two years) indicate a significant opportunity for ELVN001 [doc id='11] - **Next Steps**: Enliven Therapeutics plans to initiate a pivotal trial for ELVN001 in 2026, with a focus on both late-line and frontline settings [doc id='16][doc id='44] Conclusion - Enliven Therapeutics is optimistic about the potential of ELVN001 to become a preferred treatment option for CML, with a clear regulatory path and promising early data supporting its efficacy and safety profile [doc id='46]