As filed with the Securities and Exchange Commission on February 6, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 2834 92-1954864 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 NeOnc Technologies Holdings, Inc. (Exact name of registrant as specified in its charter) Identification Number) 23975 ...

Core Insights - Roche anticipates a mid single-digit increase in Group sales for 2026, with core earnings per share expected to grow in the high single-digit range [1] - The company plans to further increase its dividend in Swiss francs [1] Financial Performance - In 2025, Roche reported Group sales of CHF 61.5 billion, a 7% increase at constant exchange rates (CER) and a 2% increase in CHF [2][6] - The Pharmaceuticals Division achieved sales of CHF 47.7 billion, reflecting a 9% increase (3% in CHF) [7][20] - The Diagnostics Division's sales were CHF 13.8 billion, a 2% increase (decrease of 3% in CHF) [13][28] - Core operating profit rose by 13% (5% in CHF) to CHF 21.8 billion, driven by higher sales and efficiency gains [6][7] - Core earnings per share increased by 11% (4% in CHF), while IFRS net income surged by 58% (50% in CHF) to CHF 13.8 billion [7][6] Pharmaceutical Pipeline and Innovations - Roche has significant momentum in its pharmaceutical pipeline, with ten potential new medicines advancing to final-stage development and 12 late-stage clinical studies yielding positive results [3] - Key breakthroughs include advancements in treatments for lupus and estrogen receptor-positive breast cancer, which represents about 70% of all breast cancer cases [3] - The company is launching next-generation sequencing technology capable of decoding a human genome in under four hours [4] Sales Growth Drivers - The top growth drivers in the Pharmaceuticals Division include Phesgo, Xolair, Ocrevus, Hemlibra, and Vabysmo, which collectively generated CHF 21.4 billion in sales, an increase of CHF 3.2 billion compared to 2024 [8] - Sales in the United States rose by 8%, driven by continued growth of Xolair and uptake of Ocrevus, Phesgo, Hemlibra, and Polivy [9] - In Europe, sales grew by 5%, supported by strong demand for Ocrevus and Vabysmo [10] - The International region saw a 14% increase in sales, with China reporting a 10% rise due to the inclusion of Phesgo in the government drug reimbursement list [12] Diagnostics Division Developments - The Diagnostics Division introduced two instrument platforms, six digital solutions, and 53 new tests in 2025 [23] - Sales in the Diagnostics Division increased by 2% despite a 3% decline in CHF, with growth in pathology and molecular solutions offsetting pricing reforms in China [13][28] Board of Directors Changes - The Board of Directors will propose Lubomira Rochet for election as a new Board member, bringing extensive experience in business transformations [5] - Dr. Claudia Suessmuth Dyckerhoff will not stand for re-election at the Annual General Meeting in 2026 [5]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: Healthcare in China - **Focus**: Innovative drug industry and its global ambitions amid domestic challenges [1][11] Core Insights and Arguments - **Globalization Impact**: China's innovative drug industry is gaining global attention, driven by numerous license-out deals and strong clinical data. The industry is expected to leverage cost efficiency, a comprehensive supply chain, and favorable policies to continue its growth [1][11] - **Domestic Market Pressure**: The Basic Medical Insurance (BMI) system is under financial strain, with a 2.0% income growth in the first 10 months of 2025 and a significant surplus decline from RMB52.0 billion in 2024 to RMB27.3 billion in 2025. This indicates a challenging environment for domestic pharmaceutical sales [2] - **Regulatory Changes**: Chinese regulators have implemented transformative policies to control healthcare costs while promoting innovation. These include measures that compress margins for generic drugs but support R&D for innovative drugs [1][30] Investment Opportunities - **Favorable Segments**: The report favors biotech, pharmaceuticals, and Contract Research and Development Manufacturing Organizations (CRDMO) for investment, anticipating positive catalysts such as more out-licensing deals and accelerated progress of licensed assets [3] - **Company Recommendations**: - **Innovent**: Preferred for its co-development model with Takeda - **BeOne**: Noted for its leadership in BTK with Brukinsa - **Hansoh**: Expected solid growth from innovative drugs like almonertinib - **Huadong**: Defensive play with potential from GLP-1 franchise - **SNIBE**: Upgraded to Buy with a price objective of RMB74.0, reflecting strong growth potential [3][6] Clinical Trials and Cost Advantages - **Cost Efficiency**: Clinical trials in China are significantly cheaper than in developed markets, with over 40,000 clinical sites available, which enhances recruitment speed and reduces costs [14][16] - **Regulatory Framework**: Improvements in regulatory processes and a growing number of new drug IND applications (1,263 in 2024) indicate a robust environment for drug development [16][17] Supply Chain and Talent Pool - **Integrated Supply Chain**: China has established a comprehensive supply chain for drug R&D, ranking highly in various stages of drug development, including API manufacturing and clinical trials [21][24] - **Talent Availability**: The country produces over 5 million STEM graduates annually, providing a vast talent pool for the pharmaceutical industry [26] Policy Environment - **Transformative Policies**: Key policies include joining the International Council for Harmonisation (ICH), implementing Value-Based Procurement (VBP) for generics, and introducing measures to support innovative drug development [30][31] Patent Cliff Risks for MNCs - **Patent Expirations**: Major multinational corporations face significant patent expirations over the next few years, with key drugs contributing over 25% of their revenue at risk [32][35] Additional Insights - **Market Dynamics**: The shift towards innovative drugs is reshaping the competitive landscape, with companies needing to adapt to cost-containment measures affecting generic drug margins [30] - **Investment Risks**: The domestic market's pressure and the sustainability of the BMI system pose risks to pharmaceutical companies operating primarily in China [2][3]

Core Viewpoint - The article expresses optimism about Revolution Medicines, Inc. (RVMD) despite potentially negative headlines, emphasizing the importance of understanding the science behind biotech investments [1]. Company Analysis - Revolution Medicines, Inc. is highlighted as a company of interest within the biotech sector, with a focus on its clinical trials and scientific advancements [1]. Industry Insights - The article underscores the significance of educating investors on the complexities of the biotech industry, particularly regarding clinical trials and the associated risks [1].

Core Insights - Alkermes plc is a biopharmaceutical company focusing on neuroscience and oncology, making significant advancements in the sleep medicine market through its acquisition of Avadel and positive results from the Vibrance-2 study [1][5] - The company is experiencing growth, with Lybalvi sales increasing by 32%, contributing to enhanced profitability through favorable gross-to-net dynamics [2][5] - Alkermes' stock is currently priced at $29.60, reflecting a 0.82% increase, with a market capitalization of approximately $4.89 billion and a trading volume of 2,263,843 shares [3][5] Financial and Market Performance - Craig C. Hopkinson, Executive VP of Research and Development, sold 5,000 shares at $30 each, retaining 61,740 shares, indicating confidence in the company's growth trajectory [2][5] - The stock has fluctuated between $29.06 and $30.08 during the trading day, with a yearly high of $36.45 and a low of $25.17, showcasing volatility in the market [3] Clinical Developments - The success of Alixorexton in Phase 2 trials for narcolepsy and idiopathic hypersomnia, along with its clean safety profile, reduces risks in Alkermes' clinical pipeline, positioning the company favorably in the biopharmaceutical landscape [4]

FDA Approvals & Rejections - ARS Pharma's neffy, a needle-free epinephrine nasal spray for emergency treatment of Type I allergic reactions, received approval in China, with commercial availability expected in spring 2026. The product generated $31.3 million in U.S. revenue in Q3 2025 [3][4]. - Vanda Pharmaceuticals' NEREUS, an oral NK-1 receptor antagonist for preventing motion-induced vomiting, received FDA approval, marking the first new treatment for motion sickness in over 40 years. The drug demonstrated a meaningful reduction in vomiting in clinical trials [5][6]. Clinical Trials - Breakthroughs & Setbacks - InflaRx's analyses from a halted Phase 3 trial of Vilobelimab in pyoderma gangrenosum indicated potential efficacy signals with longer treatment duration, prompting plans to discuss alternative endpoints with the FDA [15][17]. - SELLAS reported that survival in its Phase 3 REGAL trial for Galinpepimut-S (GPS) in acute myeloid leukaemia is extending longer than anticipated, potentially increasing the likelihood of a positive outcome [18][19]. - Ultragenyx announced that its Phase 3 studies for Setrusumab in Osteogenesis Imperfecta failed to meet primary endpoints, leading to a decline in investor confidence [20][21]. - Genmab decided to discontinue clinical development of Acasunlimab to focus on higher-priority programs, with no impact expected on its full-year 2025 financial guidance [22][23]. Corporate Actions - FONAR Corporation agreed to be taken private by a CEO-led acquisition group for $19.00 per share, valuing the transaction at a significant premium. The deal is expected to close in Q3 2026, subject to shareholder approval [12][13][14].

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Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

The only way to figure out if drugs are safe and effective is to try them in living breathing human beings and that is extraordinarily timeconuming and incredibly expensive. I wish for the day when AI is able to fully simulate an accurate human in the computer and we don't need to do clinical trials on real people. How are you actually evaluating opportunities in the US against China competition.Because, you know, if clinical trials are the major choke point and if China seems to be trying to make that proc ...