Looking back on the development and reflection of biopharmaceuticals in 2019

In 2019, the biopharmaceutical industry has exciting development and driven industry change, but also has the exercise worthy of reflection! This is a memorable year of 1911 Alzheimer's disease (AD), the most common form of dementia, is a progressive disease, whose symptoms gradually worsen after several years, leading to death The international Alzheimer's Association estimates that more than 50 million people worldwide will have dementia in 2019, and by 2050, that number will increase to 152 million, which means that every three seconds one person will have it The disease field is one of the most active areas of new drug research and development Numerous pharmaceutical companies have laid out this field, but ad is still a big problem in human history, and there is still no effective treatment to prevent this disease In 2019, two drugs attracted great attention in this field, namely Biogen, an American biotechnology company, and aducanumab, a Japanese pharmaceutical company, and gv-971, developed by China Ocean University, Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd In the past few years, with Alzheimer's drugs failing, Biogen's aducanumab seems to be the last hope, despite the skepticism of many critics However, in March 2019, Biogen and its partner Eisai announced that they would stop the global phase III trial (energy and emerge), phase II trial evolve and long-term extended phase IB trial prime of aducanumab in patients with mild cognitive impairment of Alzheimer's disease due to the unsatisfactory results of the ineffectiveness analysis Biogen's share price also fell more than 25% as a result, and then on October 23, 2019, there was a dramatic reversal The two companies announced that they would seek regulatory approval for the drug after discussions with the FDA and further analysis of the data The main end point of phase III clinical trial was achieved, and the clinical symptoms were obviously relieved According to the company, some patients take enough high doses of drugs, and their data have significant benefits in cognitive and functional measurement, including memory, orientation and language, as well as in daily life activities Aducanumab's BLA program will be submitted to FDA in early 2020 On December 5, at the 12th clinical trial of Alzheimer's disease (ctad) conference held in San Diego, Biogen showed the complete data about aducanumab While there are some positive data that are interesting, there are also some mixed results about safety signals and between the two trials that could lead to a heated debate in the FDA about whether drugs should be approved In this regard, the "roller coaster" ups and downs of aducanumab are unlikely to end In view of Alzheimer's disease, it is worth mentioning that on November 2, 2019, China National Drug Administration issued a notice saying that the State Drug Administration has conditionally approved the application for listing registration of ganlute sodium capsule (trade name: phase 9-1, gv-971), which is used for mild to moderate Alzheimer's disease and improves patients' cognitive function It ended the history of no new drugs in the field of Alzheimer's disease in 17 years On November 11, 2019, the Ebola (Ebola) vaccine ervebo (V920) of mosadong passed the approval of the European Commission, becoming the first approved Ebola vaccine in the world, which is used for Ebola virus disease (EVD) caused by Zaire Ebola virus in people over 18 years old, also known as Ebola haemorrhagic fever Ervebo is composed of modified vesicular stomatitis virus (VSV) and an important glycoprotein on the surface of Ebola virus It can activate the immune system by producing a slight infection and make it produce antibodies against Ebola virus According to the EU approval, MSD can start the production of licensed dose in Germany, and it is expected to be launched in the third quarter of 2020 On December 19, ervebo was also approved by the US FDA, becoming the first vaccine against EVD approved by the US FDA "This is a historic milestone that demonstrates the power of science, innovation and public-private partnerships," said Kenneth C Frazier, chairman and chief executive of MSD The Democratic Republic of Congo is currently experiencing the second largest EVD outbreak in its history Since August 2018, more than 3000 people in the country have tested positive for Ebola, and more than 2000 have died in Ebola Mosadon took over the development of vaccine after the outbreak of Ebola in West Africa in 2014 Since 2015, the company has conducted very successful clinical trials in Guinea Data released by the World Health Organization in April showed that the vaccine could protect 97.5% of vaccinees Before it was approved, due to the severity of the epidemic, MSD had provided a large number of research preparations and injected them in Congo area in response to the request of the World Health Organization (who) In 2018, more than 250000 people in the country used the company's ervebo The EU and US FDA approval just obtained may be helpful for the overall promotion of ervebo Another Ebola vaccine developed by Johnson & Johnson is being vaccinated among 50000 people in Goma Goma is located on the Rwandan (RWANDA) border in eastern Congo, with a population of 2 million The difference between the two vaccines is that the J & J vaccine needs to be injected twice, eight weeks apart, while the Merck vaccine only needs to be injected once At an investor day meeting in June 2019, Frank clyburn, chief business officer of MSD, said that in the near future, keytruda would become a basic cancer treatment At present, keytruda's clinical trials involve 25 different types of cancer Keytruda is changing the way patients are treated today Although many analysts were worried about MSD's excessive reliance on keytruda at that time, with the approval of keytruda's indications, clyburn's predictions proved not to be a boast to inflate the stock price Some analysts believe keytruda is about to replace abbvie's Humira, which lost patent protection in the U.S market in 2023, as the world's largest drug sales after 2025 In addition, keytruda has been approved for more than 22 indications since 2014 According to the latest clinical data (December 12, 2019), patients with metastatic non squamous non-small cell lung cancer (NSCLC) expressing PD-L1 (tumor proportion score [TPS] ≥ 1%) in keytruda single drug first-line therapy showed improvement in overall survival (OS), progression free survival (PFS) and objective response rate (ORR), regardless of KRAS mutation status With 2020, keytruda is likely to get more approvals and more revenue in the future In November 2018, researchers at Abbott Laboratories discovered a new HIV strain, the first new HIV-1 subtype (group M) in nearly 20 years Its origin can be traced back to the Democratic Republic of Congo in Africa The discovery of this new strain means that researchers may be able to develop a potential new treatment for AIDS Since the global AIDS epidemic, more than 75 million people have been infected with HIV With the development of new drugs and new therapies, more than 37.9 million people have been able to control the disease and survive In 2019, a number of new treatments for HIV were approved For example, pifeltro and delrigo from mosadon were approved for combination therapy for HIV-1 patients; descent from Gilead was approved for pre exposure prevention of HIV In addition, many new therapies are still under development, for example, cabotegravir of Viiv under GSK and rilpivirine of Yang Sen; bone marrow transplantation using CRISPR technology and regulatory protein Brd4 invented by Professor Deng Hongkui of Peking University and his team; genetic modification of long noncoding RNA, etc It is worth mentioning that Professor Deng Hongkui was also selected as one of the top ten scientific figures in the world in 2019 released by nature with "showing that CRISPR gene editing technology can be used safely in adults infected with HIV" With the discovery of these potential therapies in 2019, there will be more options for the treatment of HIV patients in the future In 2019, the M & A of biomedical industry is hot At the same time, with the occurrence of some M & A cases, the industry pattern has also changed several times on a large scale It has to be mentioned that in January 2019, BMS announced that it would acquire celgene with us $74 billion, and the transaction was completed in November Celgene became a wholly-owned subsidiary of BMS After the merger, the company has nine products, with an annual sales of more than US $1 billion Since the merger, BMS has been approved for several drugs, including reblozyl (luspatercept AAMT) developed by celgene for the treatment of adult patients with β - thalassemia In addition, BMS announced on December 18 that it has submitted the BLA of LISO cel (CD19 car-t) to the US FDA On June 25, 2019, abbvie announced that it would acquire Allergan for a total value of about $63 billion Alberto pointed out that this large-scale deal is to rapidly expand the scale of its growth platform and achieve its strategic goal of reducing its dependence on Humira The combined company will include a number of leading areas such as immunology, blood cancer, medical aesthetics, neuroscience, women's health, eye care and virology, with high growth expected in the next decade The deal is expected to be completed by early 2020, with regulatory and Allergan shareholder approvals In February 2019, Roche, a Swiss pharmaceutical giant, announced the purchase of spark therapeutics for $4.8 billion, but the deal was repeatedly delayed as competition regulators deliberated on it After 10 months of detailed review by committee staff, Roche obtained all the anti-monopoly approvals needed to complete the transaction on December 16, and the transaction was finally settled Roche also holds two leading hemophilia therapies, in addition to its eye business also ushered in gene therapy luxturna This may be the most eye-catching M & A cases in 2019, but there are also some M & A cases that are also affecting the changes in the whole biotechnology field For example: the merger of mylan and Upjohn The new company will further expand its market by integrating the highly complementary businesses of the original two companies Many famous brands will appear in the new product pipeline, such as EPI pen, Viagra, Lipitor, Celebrex, etc., and the revenue is expected to reach 20 billion US dollars in 2020 In view of the development of new technologies such as organ repair, 3D printing has become a model of integration of biotechnology and material technology However, at this stage, the bottleneck of 3D printing materials restricts the development of 3D printing technology, and 3D printing of biomedical materials is particularly difficult However, significant progress has been made in the field of biological 3D printing technology, realizing the use of this technology to manufacture biological tissues However, no real organ has been made In April 2019, the research team of Tel Aviv University in Israel used human tissue (the research team used patients' own cells and various biological materials, such as collagen and glycoprotein) to print a complete heart in 3D for the first time Before that, the hearts printed were usually made of artificial materials "The heart is made of human cells and patient specific biomaterials that can be used as bio inks for 3D printing of complex tissue models," said tal dvir, lead researcher This heart, though small in shape, is only the size of one