东曜药业公布2022年中期业绩和公司进展

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2022年8月12日,东曜药业股份有限公司(“东曜药业”或“公司”;股票代码:1875.HK),一家专注于创新型肿瘤药物及疗法的临床阶段生物制药公司,欣然宣布其截至2022年6月30日止六个月(“期内”)未经审核中期业绩。

2022年上半年里程碑

2022年上半年,东曜药业上市产品商业化销售业绩亮眼,CDMO业务持续增长。期内,公司实现了营收1.82亿元(人民币,下同),同比大幅增长687%。其中,产品销售收入达1.04亿元,主要得益于核心产品朴欣汀®(贝伐珠单抗注射液)突出的业绩表现,CDMO及其他相关收入达7,785万元。公司净亏损进一步收窄86%至1,572万元。此外,公司获两大股东溢价认购,增资总额合计约4.7亿港元,为公司持续发展提供资金支持,进一步提高了资本市场信心。

上市产品商业化进程加速

朴欣汀®(贝伐珠单抗注射液)

朴欣汀®(贝伐珠单抗注射液)国内市场,通过与江西济民可信附属公司济鑫医药紧密合作,销售网络已覆盖全国地区(除西藏);海外市场,与科兴制药达成商业化授权许可。同时,朴欣汀®已获批包含晚期、转移性或复发性非鳞状非小细胞肺癌和转移性结直肠癌在内的全部六项适应症,市场空间进一步扩大。

替至安®(替莫唑胺胶囊)

替至安®(替莫唑胺胶囊),用于治疗新诊断的多形性胶质母细胞瘤,通过公司获选入十三省联盟、江苏省及河北省集采续约供应企业进入集采市场。另外,公司与济鑫医药达成中国市场推广合作,打通非集采市场,产品市场占有率持续提升。

美适亚®(醋酸甲地孕酮口服混悬液)

美适亚®(醋酸甲地孕酮口服混悬液),用于治疗获得性免疫缺陷综合征患者的厌食症,授权前沿生物(股票代码:688221.SH)开展内地市场推广,提升药品可及性。

在研产品主要里程碑

自研ADC药物TAA013,用于治疗经曲妥珠单抗治疗失败的、不可切除的局部晚期或转移性HER2阳性乳腺癌,国内III期临床试验入组完成,目前正在进行受试者的随访;同时,公司针对TAA013积极寻求海内外合作,并将递交EMA咨询文件。

自研单抗药物TAB014,用于治疗新生血管湿性老年黄斑部病变,完成III期临床试验首例受试者入组,并授予兆科眼科(股票代码:6622.HK)附属公司兆科广州成为其中国(包括香港和澳门)药品上市许可持有人。东曜药业将继续负责TAB014的临床及商业化生产。

商业化生产布局主要里程碑

生物药商业化生产基地具有国际竞争力,单抗原液生产规模突破20,000升,并成功进行了朴欣汀®多批次商业化生产,产品合格率100%。2022年上半年,东曜药业持续扩大商业化生产能力,不断提升ADC商业化生产平台综合力,并顺利完成了中试ADC制剂生产车间的改造升级,采用全套的一次性系统,更好地为CDMO业务服务;同时,积极推进第二条ADC制剂商业化生产线的建设。目前,公司已具备从研发、工艺开发到大规模商业化生产的全方位能力。

全球研发中心建设加快推进,预计2023年第二季度投入使用,总建筑面积达25,000平方米,具备早期研发、工艺开发、质量研究以及总部办公等功能,实现研发生产一地化,提升公司研发效率和成本优势。

CDMO业务极具竞争优势

通过苏州医药产业群集的区域优势、领先的ADC研发及大规模商业化生产技术平台、专业的CDMO管理体系和团队、按照符合NMPA/FDA/EMA法规指南的高质量要求,以及国际一流的大规模生物药商业化生产设施及能力,公司一站式CDMO业务极具竞争优势,提供从药物研发至商业化生产一站式服务

上半年,公司CDMO合作项目涉及ADC、抗体、化药等多种药物类型,项目覆盖多个临床阶段,涵盖NMPA、FDA及EMA申报。期内该业务板块收入同比高速增长94%。

股东溢价认购 

战略转型获资金支持

维梧苏州基金与晟德大药厂分别认购东曜药业116,250,000股及33,750,000股,认购价每股3.15港元,合共150,000,000股,增资总额合计约4.7亿港元。认购事项已于2022年7月29日完成,至此维梧资本与晟德大药厂持股占比分别达约28.68%及28.66%。两大股东增资认购,进一步充实公司的资本实力,为公司持续发展提供资金支持。

新冠疫情和ESG管理

● 东曜药业积极响应政府开展的一系列疫情防控工作,在严格落实防疫措施前提下,积极保产线、稳产,将新冠疫情对公司的影响降到最低,获得客户及行业伙伴的高度认可。

 东曜药业在战略及ESG(环境、社会与管治)委员会的基础上,全面透彻地对公司内外部环境进行研判,并结合公司发展实际,制定合理的常态化工作机制和目标,将ESG理念贯彻到公司经营的各个层面,有效提升公司治理水平,增强公司可持续发展能力。

未来发展

东曜药业首席执行官、首席科学官兼执行董事刘军博士表示:

“展望2022年下半年,伴随新冠疫情好转,我们将不断扩大朴欣汀®和替至安®的市场占有率,持续推进ADC核心产品TAA013的III期临床资料分析及上市进程。我们将加强拓展新的客户群体,快速提升CDMO业务规模。同时,我们将推进全球研发中心主体建设,加速ADC商业化产能升级。通过多元化融资及战略合作,持续优化公司资本结构,支持公司战略转型及CDMO业务的的快速发展。东曜药业的核心竞争力将持续增强,为股东创造更大的价值。”

财务概要

1

营业收入为1.82亿元,同比增长687%,主要来自朴欣汀®良好的销售收入、CDMO业务收入、以及产品授权金收入。

2

研发费用为70,268千元,同比下降21%,主要由于TAA013项目病人入组完成,原材料采购减少,以及产品管线优化,聚焦研发资源所致。

3

销售费用为70,091千元,同比增长526%,主要由于公司自研产品销量增加,随之带来营销推广费用的增加所致。

4

一般及行政费用为25,698千元,同比减少4%。

5

综上,2022年上半年净亏损15,724千元,同比收窄86%。

关于东曜药业股份有限公司(股票代码:1875.HK)

东曜药业致力于成为全球创新药领域客户的专业CDMO合作伙伴。凭借丰富的实践经验和成熟的技术平台及质量体系,东曜药业与国内外制药公司开展多元的战略合作,提供药物开发生产一站式CDMO解决方案,帮助客户加速生物药特别是抗体偶联药(ADC)的开发和生产,造福广大病患。

Advantages

东曜药业核心优势 

符合GMP规范的大规模生物药商业化生产基地,配备多条完整的上下游产线,采用行业高标准生产设备,总产能已突破20,000L

ADC一站式产业化平台,具备核心研发技术优势,同时ADC裸抗、原液、制剂等关键生产环节可以在一地集中完成,大幅降低转移成本,减少监管风险

已建立符合商业化生产的质量管理体系,贯穿从研发到商业化阶段的全流程,目前已支持两个上市产品的商业化生产

核心团队成熟稳定,拥有生物制药工艺开发、商业化生产、质量、法规申报等领域的丰富行业经验

获得业界高度信赖与认可的企业声誉和企业信用;坚实的CDMO服务信誉及良好的服务口碑

TOT BIOPHARM Reached New Milestones in Interim Results, with Sales Volume of over RMB 100 million, a Significantly Improved Capital Structure

On 12 August, 2022, TOT BIOPHARM International Company Limited (“TOT BIOPHARM” or the “Company”; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, was pleased to announce its unaudited interim results for the six months ended 30 June 2022 (the “Period”).

Milestones reached in the first half of 2022

In the first half of 2022, TOT BIOPHARM achieved significant results in revenue from sales of products and continued growth in its CDMO business. During the Period, the Company achieved operating revenue of RMB 182 million, a significant increase of 687% year-on-year. Specifically, revenue from sales of products reached RMB 104 million, which was mainly attributable to satisfactory sales performance of its core product Pusintin®(Bevacizumab injection); revenue from CDMO services and others reached RMB 77.85 million. The net loss of the Company was reduced by 86% year-on-year to RMB 15.72 million. In addition, the Company entered into subscription agreements with two shareholders, generating net proceeds of approximately HKD 470 million, providing financial support for the Company’s sustainable development and further boosting the confidence of the capital market.

Accelerated commercialization of products

In respect of the domestic market for Pusintin®(Bevacizumab injection), the sales network has covered all provinces and autonomous regions across China other than the Tibet Autonomous Region thanks to TOT BIOPHARM’s close cooperation with Jixin Pharmaceutical, a wholly-owned subsidiary of Jiangxi Jimin Kexin Pharmaceutical Industry Investment Co., Ltd.; as to the overseas markets, TOT BIOPHARM entered into license cooperation with Kexing Biopharm Co., Ltd.; in addition, Pusintin® has been approved for all six indications, including advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC), further opening up its markets. 

Tazian® (Temozolomide capsule), used for the treatment of newly diagnosed glioblastoma multiforme, entered the centralized procurement market as the Company was selected as the supplier in the renewal of centralized procurement by the Thirteen Allied Provinces, Jiangsu Province and Hebei Province. Meanwhile, the Company has entered into marketing cooperation with Jixin Pharmaceutical to expand its market share in China and channels in the non-centralized procurement market, driving up the market share of its products.

The Company granted Frontier Biotechnologies Inc. (stock code: 688221.SH) the marketing promotion license of Megaxia® (Megestrol acetate oral suspension), a product used for the treatment of anorexia associated with acquired immunodeficiency syndrome (“AIDS”)patients, in the mainland market to enhance the accessibility of the drug. 

Major milestones in Key Product Pipelines

Patient enrollment for Phase III clinical trial of the Company’s self-developed ADC drug TAA013 used for treating inoperable locally advanced breast cancer that has failed to be cured by trastuzumab or metastatic HER2-positive breast cancer has been completed, and follow-up interviews with the subjects are being carried out currently; meanwhile, the Company has been actively seeking domestic and overseas cooperation opportunities for TAA013 and will submit the EMA consultation paper.

The enrollment of the first patient for the Phase III clinical trial of the Company’s self-developed monoclonal antibody drug TAB014, which is used for the treatment of wet (neovascular) age-related macular degeneration (“wAMD”), was completed successfully. Besides, TOT BIOPHARM granted the license for commercialization of TAB014 in China (including Hong Kong and Macao) to Zhaoke Guangzhou (Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited), a wholly-owned subsidiary of Zhaoke Ophthalmology Limited (stock code: 6622.HK). TOT BIOPHARM will continue to be responsible for the clinical trials and commercial production of TAB014.

Major milestones in commercial production

The Company’s biopharmaceutical commercial production base is internationally competitive. The production scale of mAb drug substances has reached 20,000L, and multi-batch commercial production of bevacizumab injection (Pusintin®) products has been successfully carried out, with a product qualification rate of 100%. In the first half of 2022, TOT BIOPHARM continued to expand its commercial production capacity, improve the comprehensive capabilities of the ADC commercial production platform, and successfully completed the renovation of ADC preparations pilot production workshop, adopting complete single-use systems to better serve the CDMO business.At the same time, it actively promoted the construction of the second ADC drug products commercial production line and ADC drug substances pilot production line.Currently, the Company has a full range of capabilities from R&D to process development to large-scale commercial production.

Construction of the Company’s Global Research and Development Center is progressing at an accelerated pace. The main building is expected to be put into use in 2023, with a gross floor area of 25,000 m2 and will house functions such as early R&D, process development, quality research and head office. Placing R&D and production under one roof will help enhance the Company’s R&D efficiency and cost advantages.

Extremely competitive CDMO business

Leveraging the great location advantage of a pharmaceutical industry cluster in Suzhou, a leading ADC research & development and large-scale commercial production platform, a professional CDMO management system and team, and our world-class large-scale biopharmaceutical commercial production facilities and capabilities and according to the high-quality requirements of NMPA, FDA and EMA regulations and guidelines, the Company’s one-stop CDMO business  is extremely competitive, and providing one-stop services from drug R&D to commercial production.

In the first half of 2022, the Company's CDMO cooperation projects involved a variety of drug types such as ADCs, antibody drugs and chemical drugs, covering different clinical stages, and including NMPA, FDA and EMA applications. Revenue from CDMO services in the Period representing an increase of 94% year-on-year.

Proceeds from shareholders’ subscriptions at a premium price provided financial support for strategic transformation.

Vivo (Suzhou) Health Industry Investment Fund (Vivo Capital LLC) and Center Laboratories Inc. (Centerlab) respectively subscribed for 116,250,000 shares and 33,750,000 shares of TOT BIOPHARM at the subscription price of HKD 3.15 per share, adding up to a total of 150,000,000 shares and generating net proceeds of approximately HKD 470 million. The subscriptions were completed in full on 29 July 2022. Since then, Vivo Capital LLC and Centerlab hold approximately 28.68% and 28.66% of the Company’s shares, respectively. Subscriptions by the two largest shareholders will further enlarge the Company’s capital base and provide financial support for the Company’s continued development. 

Response to COVID-19 outbreaks and ESG management

TOT BIOPHARM has actively responded to a series of pandemic prevention and control tasks carried out by the government. While strictly implementing the pandemic prevention measures, the Company actively maintained production lines and stabilized production capacity to minimize the impact of the COVID-19 outbreaks on the Company. As such, we were highly recognized by our customers and industrial partners.

On the basis of the Strategy and ESG (Environmental, Social and Governance) Committee, TOT BIOPHARM has conducted a thorough study and review on the internal and external environments of the Company, and formulated reasonable and normalized working mechanisms and goals in line with the actual development of the Company, so as to incorporate ESG concepts into all aspects of the Company’s operations, thereby effectively improving the standard of corporate governance and enhancing the sustainable development capabilities of the Company.

Prospect

According to Dr. Liu, Jun, Chief Executive Officer, Chief Science Officer and Executive Director of TOT BIOPHARM,

“Looking into the second half of 2022, with the impact of COVID-19 easing off, we will continuously increase the market share of Pusintin® and Tazian® and promote the Phase III clinical data analysis and marketing approval process of our ADC core product TAA013. We will keep on exploring new customer groups to rapidly grow the scale of our CDMO business. We will also advance the construction of our Global Research and Development Center and accelerate the upgrade of our ADC commercial production capacity. We will continue to optimize our capital structure and support the strategic transformation of the Company and the leapfrog development of our CDMO business through diversified financing and strategic cooperation. TOT BIOPHARM’s core competitiveness will continue to be strengthened to create greater value for our shareholders.”

Financial highlights

The Company’s operating revenue reached RMB182 million , increasing by 687% year-on-year, which was mainly attributable to satisfactory sales performance of Pusintin®, fast-growing CDMO business and revenue from grant of product licenses.

The Company’s research and development expenses were RMB70,268 thousand a decrease of 21% year-on-year, which was mainly attributable to the reduction of raw material procurement as a result of the completion of patient enrollment for the TAA013 project and the optimization of product pipelines that resulted in a convergence of research and development resources.

The Company’s selling expenses were RMB70,091 thousand, representing an increase of 526% year-on-year, which was mainly due to the increase in sales of self-developed products and the increase in marketing and promotion expenses resulting therefrom.

The Company’s general and administrative expenses were RMB25,698 thousand, representing a decrease of 4% year-on-year.

In view of the abovementioned factors, the Company recorded a net loss of RMB15,724 thousand for the first half of 2022, representing a decrease of 86% year-on-year.

PR:totpr@totbiopharm.com

IR:ir@totbiopharm.com

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