S5. E2. 2020百靈佳殷格翰大事記彙整 2020 IN FOCUS

因為與COVID-19的戰爭，2020年對整個世界來說都是不平凡的一年。百靈佳殷格翰一直積極的參與，並持續尋找對抗疫情的治療方案。為了改善人類和動物健康，我們也與各領域的夥伴合作，開發了許多創新方案。

一同來看看2020百靈佳殷格翰大事記。

全球性服務計畫

百靈佳殷格翰於2020年4月啟動了一項全球性服務計畫，提供給世界各地有需要的醫療機構、社區更充裕的資金、防疫配備和藥品補助。

Jardiance^®恩排糖 慢性腎病適應症取得「快速通關許可」

2020年3月，Jardiance^®恩排糖獲美國食品藥品監督管理局（FDA）授予「快速通關許可」(Fast Track Designation)，期盼能再降低患有慢性腎臟病成人的病情發展速度，也降低因心血管疾病死亡的風險。

2020年8月公告的 EMPEROR- Reduced 試驗成果，證明恩排糖膜衣錠 empagliflozin可改善低收縮分率的心衰竭（heart failure with reduced ejection fraction）。此研究成果加速FDA、歐洲藥品管理局（European Medicines Agency，EMA）以及其他衛生機構審核的速度。

恩排糖膜衣錠 empagliflozin目前可用於降低成人第2型糖尿病的高血糖症狀，也能減低罹患心血管疾病患者的死亡風險。

合作研發因應癌症和視網膜疾病的抗體療法

2020年6月，Numab Therapeutics與百靈佳殷格翰簽訂研究合作及全球授權合約。此合作計畫包含兩個項目，著重於治療難癒型肺癌，以及患有geographic atrophy（一種不可逆的視網膜疾病）的患者。

癌症研究補充報告

百靈佳殷格翰於2020年12月宣布併購位於瑞士巴塞爾（Basel）的生物技術公司NBE-Therapeutics。此收購案為百靈佳殷格翰增添更出色的癌症標靶治療能力。NBE-Therapeutics致力於抗體藥物複合體（antibody-drug conjugate，簡稱ADC）平台，專注於癌症標靶治療。百靈佳殷格翰將持續為需要標靶治療的癌症患者，以及罹患difficult-to-treat solid tumors的患者努力。

百靈佳殷格翰也收購Labor Dr. Merk & Kollegen；該生物技術公司位於德國，專攻新興醫療產品（advanced therapy medicinal products，ATMPs）的癌症免疫學治療方案，以及研發與臨床研究。

OVEF^® 抑肺纖：獲得歐盟批准第三種適應症

2020年7月，歐盟新核准OVEF^® 抑肺纖（nintedanib）能因應的適應病症．增加為三種，可用於治療間質性肺疾病（ILD）。

加速動物健康事業中有關幹細胞療法相關研究

百靈佳殷格翰和比利時獸醫生物技術公司Global Stem cell Technology（簡稱GST）曾在2019年推出Arti-Cell^®Forte；GST為馬匹與寵物研發並生產最先進的幹細胞產品，而Arti-Cell^®Forte則是第一個以幹細胞技術為研發基礎的動物保健藥物，並取得歐盟行銷許可。在成功合作兩年後，百靈佳殷格翰於2020年7月收購了GST。

中國寵物市場的創新行動

百靈佳殷格翰於2020年9月，收購中國新瑞鵬寵物醫療集團的股權，新瑞鵬專門提供寵物醫療服務。百靈佳殷格翰與新瑞鵬的合作關係，能為中國的寵物市場帶來更多突破。中國的寵物市場是全球成長最快速的市場之一。

維也納生物製劑生產基地建立

位於奧地利維也納的大型生物製劑生產基地（ Large-Scale Cell Culture，簡稱LSCC）的籌備工作正在順利的進行中。已於2020年夏季時完成機械工程及滅菌作業。生物反應器（ bio-reactor）的無菌性是細胞培養的基礎，並已於2020末進行細胞培養物發酵的首次實驗。百靈佳殷格翰將在2021年正式啟動LSCC，這也是公司有史以來最大的一筆投資。

MMH計畫歡慶十週年

MMH健康促進計畫（Making More Health，簡稱MMH）是百靈佳殷格翰提倡的長期計畫，旨在尋找更好的全球健康促進方案。2020年是MMH計畫執行的十週年；此計畫支持了許多來自多元領域的創新提案，也增加了醫療保健的觸及率。百靈佳殷格翰與非營利組織Ashoka長期合作，藉由MMH計畫，與世界各地的社會企業家交流，一起建立了非常大的共創網絡平台。MMH計畫的重點領域包含：培育衛教知識、增加創收項目、提升基礎建設投資，以及健康加速器計畫。

微生物抗藥性之戰

微生物抗藥性（Antimicrobial Resistance；簡稱AMR）是全球最緊迫的醫學挑戰之一。百靈佳殷格翰為2020年7月啟動的AMR行動基金投入一己之力，捐款5000萬美元。這個大聯盟是由工業企業與非業界的利益相關者等多方單位及組織共同建立，希望在未來十年內為患者提供2至4種新型抗生素。

OPNME創新平台，提供免費分子，促進科學交流合作

百靈佳殷格翰運用opnMe創新平台分享自由分子，推動創新合作模式，希望在創新研究的領域更近一步。如今已收到來自59個國家／地區，1000筆以上的提案！2020年，《 Nature》期刊登出一種新型的細胞蛋白質降解機制（ protein degradation mechanism），此機制所研究分子就是由opnMe創新平台提供。

2020 IN FOCUS GLOBAL SUPPORT PROGRAM

In April 2020, Boehringer Ingelheim launched a Global Support Program to bring more financial relief, protective materials, and medicine donations to healthcare institutions and communities in need around the world.

JARDIANCE^® ON THE FAST TRACK

In March 2020, the US regulatory authority FDA granted fast-track designation for the investigation of JARDIANCE^® (empagliflozin) for reducing the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.

Positive results of the EMPEROR- Reduced trial, which investigated the effect of empagliflozin in heart failure with reduced ejection fraction, were presented in August 2020. These results led to submissions to the FDA, the European Medicines Agency, and other health authorities seeking approval for this indication.

Empagliflozin is currently approved to reduce hyperglycemia in adults with type 2 diabetes and for reducing the risk of cardiovascular death in patients with type 2 diabetes and known cardiovascular disease.

COLLABORATION TO DEVELOP ANTIBODY THERAPEUTICS FOR CANCER AND RETINAL DISEASES

Boehringer Ingelheim and Numab Therapeutics entered into a research collaboration and worldwide licensing agreement in June 2020. This collaboration started with two projects aimed at novel therapies for difficult- to-treat lung and gastrointestinal cancers and patients with geographic atrophy (GA), a progressive, irreversible retinal disease.

ESSENTIAL ADDITIONS TO CANCER RESEARCH

In December 2020, Boehringer Ingelheim announced that it is acquiring the biotechnology company NBE-Therapeutics based in Basel, Switzerland. This acquisition will add exceptional tumor targeting capabilities to the oncology portfolio of Boehringer Ingelheim. With its antibody drug conjugate (ADC) technology platform, NBE-Therapeutics focuses on targeted cancer therapies. This will add another key dimension to Boehringer Ingelheim’s focus on targeted cancer cell-directed therapies and patients with difficult-to-treat solid tumors.

In addition, Boehringer Ingelheim acquired Labor Dr. Merk & Kollegen, a German biotech company, in order to expand its R&D and clinical manufacturing capabilities in ATMP (Advanced Therapy Medicinal Products)-based cancer immunology treatments.

OFEV^® : EU APPROVAL OF THIRD INDICATION

In July 2020, the European Commission approved an additional indication for OVEF^® (nintedanib). OFEV^® is now also approved for use in adults for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

STRENGTHENING RESEARCH FOR STEM CELL THERAPIES IN ANIMAL HEALTH

After two years of successful partnership, Boehringer Ingelheim acquired the Belgium-based biotech company Global Stem cell Technology (GST) in July 2020. GST develops and produces state-of-the art stem cell products for horses and pets. Already in 2019, both companies launched ARTI-CELL^® forte in Europe, the first-ever stem cell product in the veterinary world granted marketing authorization by the European Commission.

INNOVATION FOR THE CHINESE PET MARKET

In September 2020, Boehringer Ingelheim acquired an equity stake in the China-based New Ruipeng Group, a company that specializes providing medical care services for pets. Boehringer Ingelheim is thus investing in a partnership to bring additional innovation to the Chinese pet market. China's pet market is one of the fastest growing pet markets in the world.

NEW BIOPHARMACEUTICAL PRODUCTION FACILITY IN VIENNA ON ITS WAY

Preparations for the new biopharmaceutical production facility in Vienna, the so-called Large-Scale Cell Culture (LSCC), are progressing well. The mechanical completion was finished in summer 2020 to demonstrate sterility. The sterility of bio-reactors is fundamental to cultivating cell cultures, and a first trial for the fermentation of cell cultures was performed in late 2020. Boehringer Ingelheim will inaugurate the LSCC, the single largest capital investment ever made by the company, in 2021.

MAKING MORE HEALTH CELEBRATES TEN YEARS OF SUCCESSFUL IMPACT

Making More Health (MMH) is a long-term initiative driven by Boehringer Ingelheim that seeks to identify new and better ways of improving health globally. In 2020, MMH celebrated its tenth anniversary, supporting a broad range of innovative solutions that increase access to healthcare. In building on a longstanding partnership between Boehringer Ingelheim and the non-profit organization Ashoka, MMH has since built a large network of co-creation projects with social entrepreneurs around the world. Focus areas include health awareness trainings, income generation projects, investments in infrastructures, and accelerator programs.

FIGHTING ANTIMICROBIAL RESISTANCE

The fight against antimicrobial resistance (AMR) is one of the most urgent global medical challenges. Boehringer Ingelheim is participating in the AMR Action Fund, launched in July 2020, and is contributing 50 million USD to the innovative collective venture. The broad alliance of industrial and non-industrial stakeholders aims to bring two to four new antibiotics to patients by the end of this decade.

OPNME.COM – MOLECULES FOR FREE, COLLABORATIONS FOR SCIENCE

Boehringer Ingelheim spearheads open innovation by sharing free molecules to foster independent research. Exceeding 1,000 orders from 58 countries, opnMe.com is a real success. In 2020, a paper in the scientific journal Nature analyzed a novel cellular protein degradation mechanism that was explored with one of our molecules.