The 3 breakthroughs in the pharmaceutical industry in 2017

The 3 breakthroughs in the pharmaceutical industry in 2017

An overview of the new progress in the pharmaceutical industry in 2017

In this article, I detailed 3 breakthroughs in the pharmaceutical industry in 2017.

Breakthrough of “0”: On 2 June 2017, China formally became a member of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), marking its integration into the global regulatory community.

“2”: On 30 August 2017, the U.S. FDA approved Novartis CTL-019 as the world’s first CAR-T treatment to be officially launched. Within less than 50 days, on 19 October 2017, the U.S. FDA greenlighted Kite’s Yescarta as the second global CAR-T therapy.

“2”: In the first half of 2017, the FDA greenlighted two PD-L1 antibodies in succession: Avelumab from Pfizer/Merck and Durvalumab from AstraZeneca.

$45 Billion: According to ChinaBio, Chinese VC and PE firms have raised a total of $45 billion for the life science sector in the past 30 months and had invested $12 billion so far.

In 2017, the research and development of new medications have blossomed across the spectrum of the pharmaceutical industry. A number of promising new treatments has emerged on the global stage, including CAR-T therapies, PD-1/PD-L1 antibodies, and biosimilars. China has been riding along this trend. Undoubtedly, its huge amount of capital injection and gradual improvements in related biopharmaceutical policies have both played important roles in this progress, further accelerating the advancement of the Chinese biopharmaceutical industry.

China has been riding along this trend. Undoubtedly, its huge amount of capital injection and gradual improvements in related biopharmaceutical policies have both played important roles in this progress, further accelerating the advancement of the Chinese biopharmaceutical industry.

The biopharmaceutical R&D breakthrough technologies in 2017

The production of biologics is very different from that of traditional small molecule medicines. Instead of the inorganic synthesis in tubes, biologics are manufactured in living cells – prokaryotic expression systems (E. coli, Lactobacillus, Bacillus, etc.), eukaryotic expression systems (yeast system, insect system), and mammalian cell expression systems (CHO cells, CHO-K1SV cells, CHO- S cells, HT- 1080 cells, HEK293 cells, etc.) – making its production a hard to control process. Therefore, it came as no surprise that technologies aimed to precisely analyze the growth progress of manufacturing bacteria and cells have been developed, as they are crucial to optimize the mass production and improve the yield of target products.

Therefore, it came as no surprise that technologies aimed to precisely analyze the growth progress of manufacturing bacteria and cells have been developed, as they are crucial to optimize the mass production and improve the yield of target products.

One of the rising stars is the Cedex Bio, a new generation bio-process analysis system, introduced by Roche. It can be applied to accurately determine the concentration of metabolites and substrates of bacteria and cells and to monitor and optimize the entire fermentation process in real time. The Cedex Bio supports multi-parameter culture systems, including mammalian cells, bacteria, and yeast. Thanks to its reliable photometric technology, the Cedex Bio has a very high detection sensitivity and a wide dynamic range; this enables it to obtain more accurate and stable data than the enzyme membrane method.

The Cedex Bio supports multi-parameter culture systems, including mammalian cells, bacteria, and yeast. Thanks to its reliable photometric technology, the Cedex Bio has a very high detection sensitivity and a wide dynamic range; this enables it to obtain more accurate and stable data than the enzyme membrane method.

The biopharmaceutical production capacity has achieved “qualitative changes” in 2017

The disposable bioreactor

Traditionally, the production of biologics has been carried out in the stainless-steel bioreactor system. Its shortcoming is very obvious – the poor flexibility. Once a stainless-steel system is built, it can only be used to produce one single biologic product instead of multiple, creating a huge economic burden. This problem is greatly solved by the advent of the disposable bioreactor. Other than reducing the cost, its one-time characteristics also significantly decrease the production time, as it eliminates the repeated cleaning, sterilization, and disinfection procedures.

This problem is greatly solved by the advent of the disposable bioreactor. Other than reducing the cost, its one-time characteristics also significantly decrease the production time, as it eliminates the repeated cleaning, sterilization, and disinfection procedures.

On 16 May 2017, Boehringer Ingelheim announced the official launch of its full disposable bioreactor production campus. As one of the first pilot companies to engage in the biologics contract manufacturing outsourcing in China, Boehringer Ingelheim will provide a full range of services from the process development to clinical trials to its global customers.

The large bioreactor

The development of biologics is a very complicated process. It generally needs to go through the following steps: cell bank construction, shake flask process development, small test process development, pilot scale-up, production and fermentation, purification and preparation of target proteins, etc. During this process, the volume of the bioreactor directly determines the quality of the target protein obtained in each batch. In China, due to the limitation in the manufacturing technology of large bioreactors, large volume bioreactors up to 10,000 liters are extremely rare. Difficulties as such are bottlenecks restricting the progress of China’s biologics industry.

In China, due to the limitation in the manufacturing technology of large bioreactors, large volume bioreactors up to 10,000 liters are extremely rare. Difficulties as such are bottlenecks restricting the progress of China’s biologics industry.

The good news is that on 6 December 2017, WuXi Biologics has announced its 30,000-liter biopharmaceutical manufacturing facility has fully put into production. It is the world’s largest biopharmaceutical GMP production site that uses disposable reactors. And at the same time, it is also one of the largest biopharmaceutical manufacturing bases in China. At present, a total of 134 projects are under development, including 35 Phase I and Phase II clinical trials and 92 in the preclinical stage. This marks a dramatic improvement in China’s manufacturing capacity in large bioreactors and its synergistic usage.

This marks a dramatic improvement in China’s manufacturing capacity in large bioreactors and its synergistic usage.

The modular biopharmaceutical factory

The development of biologics from research to the market is a long and costly process.  Other than unavoidable time-consuming R&D and clinical trials, building a qualified GMP factory adds another wrinkle to this issue. Therefore, a very important question to answer across the spectrum of the pharmaceutical industry is how to shorten the construction time. GE Healthcare has offered a solution.

At the beginning of last year, JHL Biotech and GE Healthcare launched the first biologic factory using GE’s medical modular biopharmaceutical solution platform KUBioTM in Wuhan. This program has significantly shortened the biologics production line construction time from the standard three years to just one year, dramatically accelerating the speed to bring a new medicine to market. As of this year, the GE Healthcare KUBioTM model has spread to Guangdong; a cluster of modular biopharmaceutical factories was established in Sino-Singapore Guangzhou Knowledge City, providing a “one-stop” public service platform for new drug research and development.

As of this year, the GE Healthcare KUBioTM model has spread to Guangdong; a cluster of modular biopharmaceutical factories was established in Sino-Singapore Guangzhou Knowledge City, providing a “one-stop” public service platform for new drug research and development.

2017 – A fruitful year for the biopharmaceutical industry

Significant advancements in the PD-1and PD-L1 field

The PD-1/PD-L1 immunotherapy is designed to take advantages of our own body’s immune system to fight off cancers. Through blocking the PD-1/PD-L1 signaling pathway, it modulates the imbalance between immune surveillance and cancer cell proliferation, potentially treating cancer of many types and substantially improving patient’s health and survival.

It has sparkled an industry-wide excitement, since it was first approved by FDA back in 2014. Until now, a total of 5 PD-1/PD-L1 antibodies has been greenlighted for the treatment of 11 tumors, including Keytruda (pembrolizumab) from MSD, Opdivo (nivolumab) from Bristol-Myers Squibb, Tecentriq (Atezolizumab) from Roche, Merck’s Avevenma (Avelumab), and AstraZeneca Of Imfinz (durvalumab) from AstraZeneca. Worth nothing is that all of them have carried out clinical trials in China from 2016 to 2017.

On the other side of the coin, the domestic development of PD-1/PD-L1 antibodies in China is plowing ahead rapidly. Currently, Hengri, Innovent Bio, and BeiGene are leading the pack, with their candidates all in phase III clinical testings; Shanghai Junshi Bioscience is following closely after, with one drug in the phase II trial.

The clinical progress of PD-1/PD-L1 antibodies in China

Since June of last year, FDA subsequently halted several combination therapy clinical trials for Bristol-Myers’s Opdivo and Imfinzi in hematologic tumors, due to its potential risks. It has been reported that PD-1/PD-L1’s monotherapies and their combination therapies with Pomarthodamine, Lenalidomide, or other drugs post greater risks than potential benefits in the treatment of relapsed or refractory multiple myeloma patients.

But just recently, FDA has lifted a partial moratorium on two combination therapy studies of Opdivo (nivolumab) in patients with MM – CA209039 and CA204142. The PD-1/PD-L1 antibody research in hematological malignancies continues.

On 2 November 2017, Bristol-Myers Squibb submitted its listing application for PD-1 antibody Opdivo to CDE; it became the first to submit a PD-1/PD-L1 antibody listing application in China and is expected to be approved in early 2018.

Shortly after, Bristol-Myers Squibb announced the results of its Phase 3 clinical trial evaluating the efficacy of nivolumab vs. docetaxel in patients with advanced or metastatic non-small cell lung cancer. It showed that nivolumab (OS) improved the total survival rate significantly.

Making this matter more exciting, in another phase III clinical trial in patients with previously treated advanced renal cell carcinoma, Opdivo increased the median survival and 3-year survival dramatically compared to Everolimus.

At present, scientists found that the therapeutic effect of PD-1/PD-L1 monoclonal antibodies is not just limited to the treatment of cancer; it can also be applied to immunodeficiency disease, such as AIDS. Researchers discovered that when using PD-1/PD-L1 antibodies in HIV-infected lung cancer patients, their HIV-infected cell reservoirs showed a dramatic and sustained decrease.

The biosimilar research is pressing ahead

A series of major biologics have experienced patent expiration recently, including Adalimumab, Etanercept, Infliximab, etc. In the wake of this phenomenon, biosimilars are facing huge market opportunities. At present, nearly 50 kinds of different biosimilars are under development.

In the first half of 2017, FDA has officially greenlighted the Infliximab’s biosimilar Renflexis from Samsung Bioepis, marking the fifth biosimilar on the US market.  Furthermore, Sandoz has recently filed for the approval of its Pegfilgrastim biosimilar to the European FDA, EMA.

In the second half of 2017, on 2 December 2017, FDA officially approved the listing of the first Herceptin biosimilar Ogivri, co-developed by Mylan and Biocon, to treat breast and metastatic gastric cancers, including these with HER2 overexpression. Worth noting is that this is also the first biosimilar drug targeted at these two specific types of cancer.

And there will be more to come in the future. Currently, an increasing number of R&D pipelines is under development. Compared to generic drugs, the price of biosimilars is not different from that of their origins, providing a higher profit margin. The benefits of biosimilars are enormous both to patients and to businesses.

Conclusion

According to IMS Health, by the year 2020, China is slated to become the second largest pharmaceutical industry in the world only after the United States. Undoubtedly, China’s biopharmaceutical industry will experience significant improvements during this process. What we need to do is to focus on the right fields. Only so, we can fly higher.

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