[Translation] A phase I clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2

主要目的：Ⅰa期：评估ARX788联合特瑞普利单抗治疗HER2表达或突变晚期实体瘤患者的安全性和耐受性，确定Ⅱ期推荐剂量(RP2D)；Ⅰb期：评估ARX788联合特瑞普利单抗治疗HER2表达或突变晚期实体瘤患者的有效性，包括客观缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)，缓解持续时间(DOR)。次要目的：Ia期：1) 评估ARX788联合特瑞普利单抗治疗在HER2表达或突变晚期实体瘤患者的有效性，包括客观缓解率(ORR)、无进展生存期(PFS)、总生存期(OS)、疾病控制率(DCR)，缓解持续时间(DOR)；2）评价ARX788联合特瑞普利单抗在HER2表达或突变晚期实体瘤患者中的药物代谢动力学(PK)特征；3）评价ARX788联合特瑞普利单抗在HER2表达或突变晚期实体瘤患者中ARX788的免疫原性。Ib期：1）评估ARX788联合特瑞普利单抗治疗HER2表达或突变晚期实体瘤患者的安全性和耐受性；2）评价ARX788联合特瑞普利单抗在HER2表达或突变晚期实体瘤患者中ARX788的免疫原性。

[Translation]

Main purpose: Phase Ia: To evaluate the safety and tolerability of ARX788 combined with toripalimab in the treatment of patients with advanced solid tumors expressing or mutated HER2, and determine the recommended dose (RP2D) for Phase II; Phase Ib: To evaluate the effectiveness of ARX788 combined with toripalimab in the treatment of patients with advanced solid tumors expressing or mutated HER2, including objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Secondary objectives: Phase Ia: 1) Evaluate the effectiveness of ARX788 combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2, including objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR); 2) Evaluate the pharmacokinetic (PK) characteristics of ARX788 combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2; 3) Evaluate the immunogenicity of ARX788 combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2. Phase Ib: 1) Evaluate the safety and tolerability of ARX788 combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2; 2) Evaluate the immunogenicity of ARX788 combined with toripalimab in patients with advanced solid tumors expressing or mutated HER2.

Start Date04 Nov 2022

Sponsor / Collaborator

NovoCodex Biopharmaceuticals Co., Ltd.Startup

CTR20222161 / RecruitingPhase 1

评价注射用重组人源化抗CD70单抗-AS269偶联物（ARX305）在晚期肿瘤患者中的安全性、耐受性、药代动力学特征及初步有效性的开放、多中心、I期临床研究

[Translation] An open, multicenter, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of recombinant humanized anti-CD70 monoclonal antibody-AS269 conjugate (ARX305) for injection in patients with advanced tumors

主要目的：评价ARX305的安全性和耐受性；确定ARX305的最大耐受剂量（MTD）和Ⅱ期研究的推荐剂量（PR2D）。次要目的：评价ARX305及其代谢产物的药代动力学特征；评价ARX305的初步抗肿瘤疗效；评估ARX305的免疫原性；评估CD70表达与ARX305疗效相关性。

[Translation]

Primary objectives: To evaluate the safety and tolerability of ARX305; to determine the maximum tolerated dose (MTD) of ARX305 and the recommended dose (PR2D) for phase II studies. Secondary objectives: To evaluate the pharmacokinetic characteristics of ARX305 and its metabolites; to evaluate the preliminary anti-tumor efficacy of ARX305; to evaluate the immunogenicity of ARX305; and to evaluate the correlation between CD70 expression and the efficacy of ARX305.

Start Date19 Oct 2022

Sponsor / Collaborator

NovoCodex Biopharmaceuticals Co., Ltd.Startup

CTR20213419 / Active, not recruitingPhase 1/2

评价重组人源化抗HER2单抗-AS269偶联物（ARX788）在HER2阳性晚期乳腺癌患者中有效性及安全性的单臂、开放Ib/II期临床研究

[Translation] A single-arm, open-label phase Ib/II clinical study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in patients with HER2-positive advanced breast cancer

主要目的：基于独立终点审核委员会（IRC）评估的客观缓解率（ORR）评价ARX788治疗HER2阳性晚期乳腺癌患者的有效性。次要目的：基于研究者评估的ORR、IRC及研究者评估的疾病控制率（DCR）、IRC及研究者评估的缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）等进一步评价ARX788治疗HER2阳性晚期乳腺癌患者的有效性；评价ARX788治疗HER2阳性晚期乳腺癌患者的安全性及耐受性；评价ARX788在HER2阳性晚期乳腺癌患者中的药物代谢动力学（PK）特征；评价ARX788的免疫原性。

[Translation]

Primary objective: To evaluate the efficacy of ARX788 in the treatment of HER2-positive advanced breast cancer patients based on the objective response rate (ORR) assessed by the independent endpoint review committee (IRC). Secondary objectives: To further evaluate the efficacy of ARX788 in the treatment of HER2-positive advanced breast cancer patients based on the ORR assessed by the investigator, the disease control rate (DCR) assessed by the IRC and the investigator, the duration of response (DOR) assessed by the IRC and the investigator, the progression-free survival (PFS), and the overall survival (OS); to evaluate the safety and tolerability of ARX788 in the treatment of HER2-positive advanced breast cancer patients; to evaluate the pharmacokinetic (PK) characteristics of ARX788 in HER2-positive advanced breast cancer patients; and to evaluate the immunogenicity of ARX788.

Start Date08 Feb 2022

Sponsor / Collaborator

Zhejiang Medicine Co., Ltd.

100 Clinical Results associated with Zhejiang Medicine Co., Ltd.

0 Patents (Medical) associated with Zhejiang Medicine Co., Ltd.

208

Literatures (Medical) associated with Zhejiang Medicine Co., Ltd.

10 Apr 2024·Industrial & Engineering Chemistry Research

Amine-Functionalized Hydrophobic Cross-Linked Polymer-Supported Palladium Nanoparticles: An Efficient Catalyst for the Selective Hydrogenation of Citral to Citronellal

Author: Liu, Dong ; Zhai, Xinyang ; Cao, Changyan ; Wang, Hongwei ; Zong, Lukuan ; Kong, Wangxin ; Zhai, Dewei ; Li, Chunliang ; Huo, Hongfei ; Liang, Lina ; Song, Weiguo ; Jiang, Pengbo

We here demonstrate that amine-functionalized hydrophobic crosslinked polymer microsphere-supported palladium nanoparticles (Pd/NFHCPs) are an efficient catalyst for the selective hydrogenation of citral to citronellal.The R₃-N groups in NFHCPs offer abundant anchoring sites for the dispersion and stabilization of Pd nanoparticles.In addition, the surface of NFHCPs is lipophilic and hydrophobic, which is beneficial for mass transformation and diffusion.These characteristics enable the catalyst to display high activity and stability for reducing citral to citronellal under alk. conditions.The effects of solvents, different auxiliaries, and wettability on the catalytic performance were systematically investigated, paving the way for its potential industrial applications.

25 Mar 2024·Sheng wu gong cheng xue bao = Chinese journal of biotechnology

[Site-specific mutation of ω-transaminase and the biocatalytic preparation of (S)-1-(2-fluorophenyl) ethylamine].

Article

Author: Wang, Pu ; Zhang, Haimin ; Yu, Shuangrong ; Sun, Xinqiang ; Qian, Feng

(S)-1-(2-fluorophenyl) ethylamine plays a crucial role as a chiral building block in pharmaceutical synthesis. ω-transaminases are widely recognized as environmentally friendly and efficient catalysts for the preparation of chiral amines. In this study, we isolated a novel ω-transaminase, PfTA, from Pseudogulbenkiania ferrooxidans through gene mining in the NCBI database. By employing semi-rational design, we obtained a Y168R/R416Q variant with enhanced enzyme activity. This variant exhibited the ability to catalyze the synthesis of (S)-1-(2-fluorophenyl) ethylamine from 2-fluorophenone, achieving a yield of 83.58% and an enantioselectivity exceeding 99% after a 10 h reaction. Compared to the wild type, the specific enzyme activity of the Y168R/R416Q variant reached 47.04 U/mg, which represents an increase of 11.65 times. Additionally, the catalytic efficiency, as measured by k_cat/K_m, was increased by 20.9 times. Molecular docking and structural simulation analysis revealed that the primary factor contributing to the improved catalytic efficiency is the expansion of the enzyme's active pocket and the alleviation of steric hindrance.

01 Dec 2023·Applied Microbiology and Biotechnology

Enzymatic properties of a non-classical aldoxime dehydratase capable of producing alkyl and arylalkyl nitriles

Article

Author: Yang, Fengling ; Xiao, Qinjie ; Feng, Yumin ; Li, Nanxing ; Wang, Anming ; Pei, Xiaolin ; Wang, Qiuyan ; Chen, Li

Nitriles are of significant interest in the flavor and fragrance industries with potential application in cosmetics due to their higher stability than analogous aldehydes. However, the traditional methods to prepare nitriles need toxic reagents and hash conditions. This work aimed to develop a chemoenzymatic strategy to synthesize nitriles from natural aldehydes with aldoxime as the intermediate. A non-classical aldoxime dehydratase (Oxd) was discovered from the fungus Aspergillus ibericus (OxdAsp) to catalyze the dehydration of aldoximes to corresponding nitriles under mild conditions. The amino acid sequence of OxdAsp exhibits an approximately 20% identity with bacterial Oxds. OxdAsp contains a heme prosthetic group bound with the axial H287 in the catalytic pocket. The structure models of OxdAsp with substrates suggest that its catalytic triad is Y138-R141-E192, which is different from the classically bacterial Oxds of His-Arg-Ser/Thr. The catalytic mechanism of OxdAsp was proposed based on the mutagenesis of key residues. The hydroxyl group of the substrate is fixed by E192 to increase its basicity. Y138 acts as a general acid-based catalyst, and its phenolic proton is polarized by the adjacent R141. The protonated Y138 would donate a proton to the hydroxyl group of the substrate and eliminate a water molecule from aldoxime to produce nitrile. The recombinant OxdAsp can efficiently dehydrate citronellal oxime and cinnamaldoxime to citronellyl nitrile and cinnamonitrile in aqueous media, which are applied as fragrance ingredients in the food and cosmetic fields. KEY POINTS: • A novel aldoxime dehydratase from the Aspergillus genus was first characterized as a heme-binding protein. • The catalytic mechanism was predicted based on the molecular interactions of the catalytic pocket with the substrate. • A chemoenzymatic strategy was developed to synthesize nitriles from natural aldehydes with aldoxime as the intermediate.

News (Medical) associated with Zhejiang Medicine Co., Ltd.

22 Oct 2023

·www.fiercebiotech.com

ESMO: Ambrx's 'reset' arrives at the last line of prostate cancer, offering the kind of safety rarely seen

Almost a year to the day before Ambrx's ESMO presentation, the company laid off 15% of its staff and trimmed the pipeline down to ARX517 and a couple other early-stage assets. MADRID—When patients reached Ambrx Biopharma’s phase 1/2 clinical trial for prostate cancer, they were nearing the end of their treatment journey. It’s hard to read that some had gone through 13 rounds of treatment before they entered the study. CEO Daniel O’Connor and Chief Clinical Officer Sandra Aung don’t take that lightly. “They're last line patients, they have no other options and typically patients in that bucket go for clinical trials,” Aung said on the sidelines of the European Society for Medical Oncology Congress in Madrid. Ambrx wants to provide another option, but more importantly, a better option for these patients who are facing difficult decisions after a long fight with cancer. The company unveiled early-stage data from the APEX-01 study of the antibody-drug conjugate (ADC) ARX517 showing anti-cancer activity and few adverse events—none serious. For efficacy, Ambrx reported that more than half of the 23 patients had a 50% or more reduction in prostate specific antigen, which is elevated in prostate cancer. Seventeen out of 21, or 81% of evaluable patients, also had a steep reduction in circulating tumor DNA. In a smaller analysis of six patients, half who had prior prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy, had more or equal to 50% reduction in prostate specific antigen. And out of four evaluable patients, half had a 30% or more reduction in target lesions. There were no treatment-related serious adverse events or dose limiting toxicities, a discontinuation rate of just 3.1% and fewer than 10% grade 3 treatment related adverse events—but no grade 4 or 5s. Aung said the safety data are particularly important for these late-stage patients: “We don’t want to make them sicker.” “I don't know if I've ever seen a late-stage cancer drug, after two years of clinical development, not having an [serious adverse event]. Not one,” O’Connor said in an interview. The grade 3 events were lymphocyte count decreases, platelet count decreases and one instance of left ventricular dysfunction, which Aung said was found in the course of the treatment and was not considered serious. “We don't want to diminish what a grade 3 is, but on a grand scheme of things for this late-line patient on this drug, [it’s] very tolerable. We would feel very comfortable calling it strong safety,” Aung said. While the data are from a small population, Ambrx is already forming a detailed strategy of next steps. Aung said that the safety profile resulted from the biotech’s careful testing and drug discovery process. “It's very rare to find this kind of safety profile. It is really born from technology, it's not luck,” she said. There’s still a lot to do in the clinic, including fully enrolling the study and conducting dose expansion, O’Connor said. With so few safety events, he thinks the dose can go higher to push efficacy even further. “Ultimately, if we see a data plateau and we see an impact over efficacy, we'll make a decision probably not to move forward to a higher level,” O’Connor said. “It's incumbent on us to continue to explore higher doses to see if there's more efficacy.” Ambrx also saw in the small dataset the possibility that the treatment will work regardless of a patient’s PSMA biomarker levels, which would mean ARX517 could have access to a wide patient population. The trial did not screen for PSMA, so the patients had a mix of high and low levels. “If we don't have to have a biomarker program, we do not want to have one,” O’Connor said. Aung said they are certainly going to collect that data, but the goal is not to pick one population over the other. “We want to be able to treat patients, not have to select them,” she added. “We're going to collect it and we're going to look at the data and make a decision on whether it's necessary or not.” Ambrx's scorecard The ESMO presentation represents a major reset for Ambrx. Almost a year to the day, the biotech laid off 15% of its staff and trimmed the pipeline down to ARX517 and a couple other early-stage assets. The dramatic moves came after a breast cancer program fell apart. “Focus is really the key for us. And I think frankly, we’re really pleased with the progress the company has made this year,” said O’Connor, who took the helm in November 2022 after the layoffs. “There was a reduction that happened last fall. A year later, there's really kind of a complete change. A reset.” Aung is another fresh face, having taken on her role in February. Ambrx has also managed to raise some cash and extend its runway to 2026, all in a market O’Connor admits is challenging for the larger industry. The most recent offering in June closed with $75 million, which followed a $78 million raise in March. Even the breast cancer program, initially the cause of the company cutbacks, is returning. In March, Ambrx said that a phase 2 study in China conducted by partner NovoCodex Biopharmaceuticals showed that ARX788 demonstrated better progression-free survival than the control group. O’Connor moved to resurrect the drug. “It was shelved not because of efficacy, it was shelved because the company was concerned about cash burn a year ago, just before I was the CEO,” O’Connor said. Ambrx always believed there was a signal in the data. Now, he says Ambrx is conducting a small signal-finding study in a group of breast cancer patients who have no other options. The FDA had previously granted a fast-track tag for the treatment. “On each scorecard, we feel like we've really changed the trajectory of the company. And we are really pleased with the progress,” O’Connor said.

Phase 2ADC

16 Jun 2023

·www.prnewswire.com

Global Natural Source Vitamin E (Tocopherols and Tocotrienols) Market: Demand for Natural Vitamin E is Projected to Reach About 20K Metric Tons by 2028

DUBLIN, June 16, 2023 /PRNewswire/ -- The "Natural Source Vitamin E (Tocopherols and Tocotrienols) - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. Global demand for Natural Source Vitamin E reached US$1.1 billion in 2022, registering a YOY growth of 17% attributed to huge price increase in Tocopherols. Dietary Supplements sector is the largest consumer of Natural Vitamin E worldwide and any upturns and downturns in the demand from Dietary Supplements will directly reflect in the overall Natural Vitamin E market. Amid the pandemic induced upturn in the demand for supplements and fortified foods & beverages, the global Natural Vitamin E consumption has significantly increased during 2020-2021 period. Demand growth for supplements and fortified foods slowed down likewise significantly in 2022 as the threat by the pandemic continued to wane and the global economic conditions weakened. Rising energy costs, supply chain disruptions and tight supply of vegetable oil distillates has prompted Tocopherols producers to increase prices during the 2021-2022 period. As evident from the industry, vitamin E prices are expected to remain stable at 2022 levels during the forecast period (2022-2028) as the global supply chain conditions are improved and energy costs are coming down. In light of high inflation and rising Tocopherols prices, consumers are likely to become increasingly price sensitive heading into the forecast period, and the global volume consumption of Natural Vitamin E is projected to progress at a moderate CAGR of 3.6% between 2022 and 2025. As economic conditions are expected to back to normal after 2025, the global demand for Natural Vitamin E is projected to reach about 20K metric tons by 2028. Research Findings & Coverage Global Natural Source Vitamin E market is analyzed in this report with respect to key product types and major end-use sectors The study exclusively analyzes the market size of each product type and end-use sectors of Vitamin E by a major geographic region/country The market for Natural Vitamin E Tocopherols and Natural Vitamin E Tocotrienols is analyzed by end-use applications individually for all major regions/countries Analysis of Market Drivers, Restraints and Opportunities In-depth analysis is covered for global Natural Vitamin E market with respect to rising prices and inflation while the study also takes the recent pandemic impact in to consideration Production capacity shares of all major Tocopherols and Tocotrienols producers are analyzed Key business trends focusing on product innovations/developments, M&As, JVs and other recent industry developments Major companies profiled - 43 The industry guide includes the contact details for 223 companies Product Outline The report analyzes the market for the following key product types of Natural Vitamin E: Tocopherols Tocotrienols End-Use sectors of Natural Vitamin E analyzed comprise the following: Animal Nutrition/Feed Dietary Supplements Food and Beverages Cosmetics & Personal Care Others (include pharmaceuticals, medical nutrition, and infant nutrition) Analysis Period, Units and Growth Rates The report reviews, analyzes and projects the global Natural Vitamin E market for the period 2019-2028 in terms of volumes in Metric Tons and market value in US$ and the compound annual growth rates (CAGRs) projected from 2022 through 2028 with a special focus on y-o-y growth analysis for 2021-2022 Geographic Coverage North America (The United States, Canada and Mexico) Europe (Germany, France, Italy, Spain, The Netherlands, The United Kingdom and Rest of World) Asia-Pacific (China, India, Japan and Rest of Asia-Pacific) South America (Brazil, Argentina and Rest of South America) Rest of World Key Topics Covered: PART A: GLOBAL MARKET PERSPECTIVE 1. INTRODUCTION 1.1 Market Trends and Outlook 1.2 Overall Vitamin E Market At-a-Glance 1.3 Product Outline 1.3.1 What is Vitamin E? 1.3.2 Forms of Vitamin E 1.3.2.1 Synthetic Vitamin E 1.3.2.2 Natural Source Vitamin E 1.3.2.2.1 Tocopherols 1.3.2.2.2 Tocotrienols 1.3.2.2.3 Vitamin E TPGS (d-Alpha Tocopheryl Polyethylene Glycol 1000 Succinate) 1.3.3 Manufacturing Processes of Vitamin E 1.3.3.1 Synthetic Vitamin E 1.3.3.2 Natural Source Vitamin E 1.3.3.2.1 Tocopherols 1.3.3.2.2 Tocotrienols 1.3.4 Sources of Vitamin E 1.3.4.1 Food Sources 1.3.4.2 Dietary Supplements 1.3.5 Vitamin E Health Claims 1.3.5.1 Coronary Heart Disease 1.3.5.2 Cancer 1.3.5.3 Disorders of the Eyes 1.3.5.4 Cognitive Decline 1.3.5.5 Other Health Claims 1.3.6 End-Use Applications of Vitamin E 1.3.6.1 Animal Nutrition 1.3.6.2 Human Nutritional/Dietary Supplements 1.3.6.3 Functional Food and Beverages 1.3.6.4 Cosmetics 1.3.6.5 Other Applications 2. REGULATIONS FOR DIETARY SUPPLEMENTS AND INGREDIENTS 2.1 Ministry of Health Malaysia Approves Two Health Claims for Palm Tocotrienols 2.2 Regulations for Dietary Supplements and Ingredients as per the US Food and Drug Administration (FDA) 2.2.1 How the Safety of Dietary Supplements is Ensured 2.2.2 Registration of Food Facilities 2.2.3 Notification Process for New Dietary Ingredients 2.3 FDA Changes Nutrition Facts Label on Food Packaging 2.3.1 FDA Guidance for Industry on Converting Units of Measure for Vitamin E 2.4 European Union: Traceability and Labeling of GMOs 3. INDUSTRY LANDSCAPE 3.1 Global Vitamin E Production Capacities 3.1.1 Global Natural Vitamin E Tocopherols Capacity 3.1.2 Global Natural Vitamin E Tocotrienols Capacity 3.2 Natural Vitamin E Tocopherols Manufacturers Advanced Organic Materials S.A. (Argentina) Archer Daniels Midland Company (United States) BTSA Biotecnologias Aplicadas Sl (Spain) COFCO Tech Bioengineering (Tianjin) Co., Ltd. (China) DSM Nutritional Products (Royal DSM NV) (Netherlands) Cargill, Inc (United States) ECA Healthcare Inc. (China) Fairchem Organics Limited (India) Fenchem Biotek Ltd. (China) Fujian Fuerjin Biotechnology Co., Ltd. (China) Fujian Glanny Bio-Engineering Co., Ltd. (China) Jiangsu Conat Biological Products Co., Ltd. (China) Jiangsu Xixin Vitamin Co., Ltd. (China) Jiangsu Yuehong Bio-Tec Co., Ltd. (China) Jiangxi Aturex Co Ltd (China) J-Oil Mills, Inc. (Japan) Kensing, LLC. (United States) Vitae Naturals (Spain) Matrix Life Science Pvt. Ltd. (India) Mitsubishi-Chemical Foods Corporation (Japan) Tama Biochemical Co., Ltd. (Japan) Ningbo Dahongying Bio-Engineering Co., Ltd. (China) Riken Vitamin Co., Ltd. (Japan) Shandong New Element Biotechnology Co., Ltd. (China) Vitae Naturals (Vitae Caps, S.A.) (Spain) Wilmar Spring Fruit Nutrition Products (Jiangsu) Co., Ltd. (China) Xi'an Healthful Biotechnology Co Ltd (HSF) (China) Yichun Dahaigui Life Science Co., Ltd. (China) Zhejiang Medicine Co., Ltd. (China) Zhejiang Worldbestve Biotechnology Co., Ltd. (China) 3.3 Natural Vitamin E Tocotrienols Manufacturers American River Nutrition, Inc. (United States) Beijing Gingko Group (China) ExcelVite Sdn. Bhd. (Malaysia) KLK Oleo (Davos Life Science) (Singapore) Musim Mas Group (Singapore) Oryza Oil & Fat Chemical Co., Ltd. (Japan) Pwani Oil Products Limited (Kenya) ORAH Nutrichem Exim Pvt. Ltd. (India) Phytogaia Sdn. Bhd. (Malaysia) Sime Darby Oils Nutrition (Malaysia) SOP Nutraceuticals Sdn. Bhd. (Malaysia) Supervitamins Sdn. Bhd. (Malaysia) Vance Group Ltd. (Singapore) 4. KEY BUSINESS TRENDS Kensing Acquires Spain-based Natural Vitamin E Producer Vitae Naturals ORAH Nutrichem Introduces ORAH VIT E Tocotrienol based Natural Antioxidant Kensing Inks Distribution Deal with Azelis in the EMEA Region One Rock Capital Partners Acquires BASF's Kankakee, Illinois Natural Vitamin E Plant Antares Introduces Pharmaceutical and Food Grade Non-GMO Sunflower TPGS 5. GLOBAL MARKET OVERVIEW 5.1 Global Natural Vitamin E Market Overview by End-Use Application 5.2 Global Natural Vitamin E Market Overview by Type 5.2.1 Natural Vitamin E - Tocopherols 5.2.1.1 Global Natural Vitamin E Tocopherols Market Overview by End-Use Application 5.2.2 Natural Vitamin E - Tocotrienols 5.2.2.1 Global Natural Vitamin E Tocotrienols Market Overview by End-Use Application PART B: REGIONAL MARKET PERSPECTIVE Natural Vitamin E Market Overview by Geographic Region Global Natural Vitamin E Tocopherols Market Overview by Geographic Region Global Natural Vitamin E Tocotrienols Market Overview by Geographic Region REGIONAL MARKET OVERVIEW 6. NORTH AMERICA 7. EUROPE 8. ASIA-PACIFIC 9. SOUTH AMERICA 10. REST OF WORLD PART C: GUIDE TO THE INDUSTRY 1. Major Manufacturers and Suppliers of Vitamin E Manufacturers of Natural Vitamin E Tocopherols Manufacturers of Natural Vitamin E Tocotrienols Vitamins and Other Ingredients Distributors 2. Major Companies in the End-use Application Industries for Vitamin E Nutritional Supplements Companies Direct Selling Companies - Supplements and Personal Care Contract Manufacturers - Supplements Animal Feed/Nutrition Companies Vitamins and Other Ingredients Distributors and Formulators PART D: ANNEXURE 1. RESEARCH METHODOLOGY 2. FEEDBACK For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

02 Mar 2023

·pipelinereview.com

ACE-Breast-02 Pivotal Phase 3 Study of Ambrx’s ARX788 for the Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results

Interim analysis of the ACE-Breast-02 study being conducted by Ambrx’s partner, NovoCodex Biopharmaceuticals, was completed by the Independent Data Monitoring Committee (IDMC) The pivotal Phase 3 ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival benefit compared to the control SAN DIEGO, CA, USA I March 01, 2023 I Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM) announced today that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase 3 breast cancer clinical trial investigating Ambrx’s ARX788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control. ACE-Breast-02 is a randomized, controlled pivotal Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China. The trial enrolled 441 HER2 positive breast cancer patients who have been previously treated with taxane and trastuzumab. Eligible subjects were randomly assigned in a 1:1 ratio to receive ARX788 or the control drugs, lapatinib combined with capecitabine. The primary endpoint was PFS based on Blinded Independent Review Committee (BIRC) assessment. An interim analysis was conducted by an Independent Data Monitoring Committee (IDMC) when two thirds (2/3) of the PFS events occurred. After reviewing the interim results, the IDMC informed NovoCodex that the ACE-Breast-02 study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater PFS benefit compared to the control. Based on the results from the interim analysis, NovoCodex plans to submit a communication application to seek marketing approval in China pending discussion with National Medical Products Administration (NMPA). Daniel O’Connor, Chief Executive Officer of Ambrx commented: “We congratulate our partner, NovoCodex, on this positive Phase 3 study. The positive results from this large Phase 3 study provide further support for our rationale to develop ARX788 globally in HER2 positive breast cancer patients.” ARX788 is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials with our partner NovoCodex. The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2 positive metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer. The NMPA has granted Breakthrough Therapy Designations for ARX788 in breast cancer. In June 2013, Ambrx entered into a collaboration with Zhejiang Medicine Co., Ltd., which was transferred to it subsidiary NovoCodex, to develop and commercialize ARX788, Ambrx’s most advanced internally developed site-specific ADC targeting HER2-positive breast cancer. Under the agreement, NovoCodex licensed commercial rights for ARX788 in China while Ambrx retained commercial rights outside of China and is entitled to receive royalties on sales of ARX788 in China. About Ambrx Biopharma Inc. Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop Engineered Precision Biologics. These include next generation antibody drug conjugates (ADCs) and other engineered therapies to modulate the immune system. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety in multiple cancer indications, including ARX517, its proprietary ADC the prostate-specific membrane antigen (PSMA) and ARX788, its proprietary ADC targeting HER2. In addition, Ambrx has preclinical and clinical collaborations with multiple partners for drug candidates generated using Ambrx technology. Ambrx spun out of The Scripps Research Institute in 2003 and has several other product candidates involving ADCs and other aspects of Ambrx’s protein engineering technology. For more information, please visit www.ambrx.com. SOURCE: Ambrx Biopharma

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Vancomycin Hydrochloride ( Peptidoglycan )	Enterocolitis More	Approved
Anvatabart opadotina ( HER2 x Tubulin )	HER2-positive gastric cancer More	Phase 3
Bedoradrine Sulfate ( β2-adrenergic receptor )	Asthma More	Phase 2
ARX-305 ( CD70 )	Advanced cancer More	Phase 1
XCCS605B ( Chk1 )	Colonic Cancer More	Phase 1

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