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    Home > Medical News > Latest Medical News > Shanghai pharmaceutical companies trapped in the epidemic: production and research and development are almost shut down, how long can they last?

    Shanghai pharmaceutical companies trapped in the epidemic: production and research and development are almost shut down, how long can they last?

    • Last Update: 2022-05-12
    • Source: Internet
    • Author: User
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    In the month before April 16, 2022, losing an "astronomical amount" every day is the daily routine of Shanghai enterprises under the control of the epidemic



    As a representative of a pharmaceutical company, Xu Xiaomai (pseudonym) recently participated in a discussion organized by the Ministry of Commerce to learn about the actual situation of representative companies in various industries during the epidemic control period



    At the end of March, her pharmaceutical company factory began closed management



    Another medical Weibo blogger named An Xiaoan publicly stated that recently, he felt like he had fallen into the three-body world, which was absurd and unreal



    "Except for the nucleic acid testing industry, I really don't know how other companies can maintain the state of closure and control? If you talk on the phone at home every day, you can promote the project? Can you feed the whole company?" These questions were asked on April 16.



    Under the control of the epidemic, these two pharmaceutical companies are the epitome of thousands of pharmaceutical companies in Shanghai's "Zhangjiang Pharmaceutical Valley"



    But it is in this benchmarking "Holy Land of Medicine" that biotechs are going through a difficult journey to return to work


    The "Guidelines" clearly pointed out that under the premise of ensuring that risks are controllable, closed-loop management should be implemented to effectively and orderly promote the resumption of work and production of enterprises, and to ensure the safety and stability of the industrial chain and supply chain



    The machinery of a pharmaceutical factory cannot stop, so that both the company and the patient can "live"




    - 01 -

    The machine in the pharmaceutical factory turns: the production line is also a "lifeline"


    In fact, before the announcement of the first batch of work resumption lists, pharmaceutical companies were already working hard to save themselves
    .


    A number of local pharmaceutical companies said that employees in their production departments have been under closed management since the end of March
    .
    Most of them eat and live in factories, and some rent hotels for employees to live in, but they are also closed-loop management
    .
    Some important and urgently needed medicines are still being produced at a minimum level
    .


    Even so, there are still some unexpected surprises
    .
    A research and development staff of a pharmaceutical company revealed: "Some time ago, there was a CDMO (Contract R&D and Manufacturing Organization) company that was also under closed management.
    Suddenly an employee tested positive for nucleic acid, and then the entire production was stopped
    .
    "


    Some pharmaceutical companies are not fortunate to be closed and managed.
    A foreign company is in Minhang District, the "hardest hit area" of the epidemic.
    This area is also the first area in Shanghai to start closed management, and its production is basically at a standstill
    .
    "Because of the early closure and control, our production colleagues cannot return to the factory
    .
    " An employee of the company revealed that because the production of its Shanghai factory is supplied to the whole country, once it stops, the impact will be huge
    .


    And for those pharmaceutical companies that can still maintain production, many are consuming previous inventories (raw materials and consumables)
    .
    Some can last for a few months, and fortunately, they have prepared inventory for half a year or more than a year
    .
    In fact, most pharmaceutical companies have such a plan, which is usually used to prevent supply chain disruptions
    .
    "(The closure) can last for a month or two, but once it is closed for a long time, it will be very troublesome
    .
    "


    When the materials in stock are always used up, it is inevitable to import raw materials/consumables from overseas
    .
    The problem of import inspection and customs clearance has affected local companies.
    The staff of a pharmaceutical company learned that many imported consumables need customs clearance.
    "For example, the bags used for cell culture may have to be left in the warehouse at the airport for 14-day quarantine observation.

    .
    "


    In fact, the first to be stuck by import inspection and customs clearance, and the biggest impact is the pharmaceutical foreign companies
    .
    As one of the two major import ports in the country, the Shanghai port cannot flow into the domestic market from here, which is a major loss for pharmaceutical companies
    .
    Some medicines have been delayed due to the interruption of international logistics, and some medicines have already arrived in China, but they cannot be inspected for approval and customs clearance
    .


    According to industry insiders, an institutional survey in early April showed that 51 products (standards) of 16 foreign companies had import inspections and customs clearance affected by the epidemic
    .
    The drugs include belintuzumab for injection (for acute lymphoblastic leukemia), cetuximab injection (for rectal cancer), atezolizumab (for small cell lung cancer), etc.
    Including Amgen, Eli Lilly, Roche, Sanofi,
    etc.


    In addition, the above-mentioned people have learned that some pharmaceutical companies need to import drugs from abroad.
    They are the winning bidders for centralized procurement, and the supply may be a little tight now
    .


    Among these drugs, tumor drugs are urgently needed to ensure a stable supply, and they are life-saving drugs for some people
    .
    "Tumor patients are out of medicine, which is very dangerous
    .
    " In fact, hospitals have limited stocks of such medicines, and they need to keep importing them continuously
    .


    According to the current epidemic prevention requirements, some imported medicines need to be stored in the warehouse for 7 days, "because they are worried that the medicines are packed with the new coronavirus, but many medicines cannot be stored for such a long time, or the storage conditions do not meet the requirements
    .
    " A person from a foreign company said that many Tumor drugs are biological preparations with high storage conditions and high requirements on the cold chain
    .


    It can be said that foreign pharmaceutical companies prefer to root their Chinese headquarters in Shanghai
    .
    In 2020, among the TOP10 of the world's top pharmaceutical companies, 8 companies have their Chinese headquarters in Shanghai
    .
    At the same time, many foreign pharmaceutical companies choose to introduce drugs at the Shanghai port.
    As early as 2003, about one-third of the imported drugs in the country were imported from here
    .


    Now that the Shanghai port is blocked, why not try another port?


    The reality is not so simple.
    Behind the port change is a very large workload, which involves a series of reiteration and replacement of administrative procedures, supplier channels,
    etc.
    A person from a foreign company said frankly: "If we switch to the Beijing port, the formalities will take a month
    .
    "


    A single trigger affects the whole body, and the interruption of drug production and sales is unbearable for both companies and patients
    .
    For the import of life-saving drugs, can special adjustments be made under special circumstances?


    "Let the medicine come in first, and then make up (check) later, or even fine after the fact
    .
    " The above-mentioned people suggested with concern
    .



    - 02 -

    R&D paused 'in the midst of a storm'


    If maintaining production is the bottom line that cannot be given up, pharmaceutical companies are much more comfortable with the suspension of research and development
    .
    "The interruption of supply chain/production is an acute death, and the interruption of scientific research is a chronic death
    .
    The scientific research cycle is long, and the interruption of one or two months does not make a big difference, but after two or three years, there will be problems
    .
    "


    The research and development of some pharmaceutical companies may be less affected, and they entrust CRO or CDMO companies for OEM research and development
    .
    Most of the laboratories of such enterprises are not located in Shanghai, and the epidemic control is relatively loose.
    Under such circumstances, research and development may continue to advance
    .


    There are also many pharmaceutical companies who said that during the epidemic control period, most of their early R&D departments worked from home
    .
    It is almost impossible to go to the laboratory.
    "It involves many departments such as R&D/analysis/pilot production.
    The previous timeline (R&D node) was quite tight, and now it must be pushed back
    .
    " A pharmaceutical company R&D staff said , one of the most immediate effects is that they may not catch up with the world-class medical research and development conferences in some years
    .


    Some pharmaceutical companies have to suspend clinical trials in Shanghai, and some companies may waste hundreds of thousands of yuan
    .
    Because the two main groups of people are isolated at home - CRA (clinical monitor) and recruited clinical patients
    .
    The dosing of some clinical patients was subsequently interrupted, which also meant that the test samples were gone and even "dropped out" in the clinical trial
    .


    A well-known biotech company once wanted to use a special vehicle to transport clinical trial patients in a closed loop, but this plan could not be carried out under strict epidemic prevention and control
    .


    "It is sometimes difficult to recruit patients, especially those with rare diseases
    .
    " Once "dropped", it means that time and money are involved, because many tests may have been done on these patients before, which cost hundreds of thousands of dollars.
    yuan drug
    .
    However, many patients who "drop out" cannot be re-enrolled, which requires finding new patients
    .


    Of course, some pharmaceutical companies do not put all their eggs in one basket, and their clinical trial patients are adjusted to other regions
    .
    Enrollment in Shanghai has been slow, and we will turn to other cities to see if we can catch up
    .


    In addition to the problem of patients falling off, many pharmaceutical companies are also facing the problem of clinical trial drugs
    .
    In particular, tumor drugs need to be imported from abroad for clinical trial placebos, as well as treatment drugs for control groups
    .
    However, due to the impact of the above-mentioned import commodity inspection and customs clearance, some pharmaceutical companies have already completed half of their clinical trials, and no drugs are available
    .


    Shanghai is an important city for domestic drug clinical trials.
    In the ranking of provinces/municipalities with the largest number of drug clinical trials in 2021, Shanghai (901) ranks second after Beijing (1066)
    .
    Some people think that the suspension of clinical trials cannot be cost-effective.
    "It can be overcome with a delay of two or three weeks.
    If it is as long as two or three months, there may be a lot of lag
    .
    "


    If R&D can’t keep up, then the marketing department that makes plans next will also miss a lot of marketing windows
    .
    "However, the marketing department usually has plan B, and they will try to do it online, but the effect will be a little worse
    .
    " said a marketing department staff member of a pharmaceutical company
    .


    The domino effect has also spread to the medical representatives.
    The epidemic lockdown has greatly reduced the business volume of Shanghai hospitals, and a large number of doctors have rushed to the front line of isolation
    .
    The number of patients visiting outpatient clinics during isolation has plummeted, and most of them are compressing their medication doses, or even keeping them to a minimum
    .
    Just last year, Shanghai was the city with the largest number of patients in the country
    .
    The number of patients treated by medical institutions in Shanghai reached 272 million, surpassing the 243 million in Beijing
    .


    And medical representatives are fighting for sales, and some people gave a very pessimistic forecast: "Sales in March have been affected, and (sales) in April cannot be viewed, and (sales) in the second quarter of this year may not be available.

    .
    "


    Things seem to have improved recently
    .
    On April 24, the press conference on the prevention and control of the new coronary pneumonia epidemic in Shanghai stated that compared with the beginning of April, the outpatient volume of 36 municipal hospitals increased by 103%, and the emergency volume increased by 65%; Up, the number of surgeries last week doubled compared to the beginning of April
    .



    - 03 -

    The predicament of resumption of work and the possible ebb of talent


    Production cannot be stopped, because pharmaceutical companies and patients must "live"
    .


    Even if the production machines of many pharmaceutical companies have not stopped running, most of them only maintain the minimum number of personnel in the production department compared to when they were not closed and controlled, which is actually not enough to maintain normal production
    .


    On the one hand, pharmaceutical companies that focus on self-research business stand on the edge of the abyss where their operations are unsustainable, and will face fatal blows over time; on the other hand, as third-party production service organizations, CXO and API companies in Shanghai The impact cannot be underestimated
    .
    Its ability to deliver (timeliness of work delivery) may be slower
    .


    A person from a CDMO company admitted: "The production department is temporarily delayed in delivery, which is understandable for overseas customers
    .
    However, it is still necessary to resume work as soon as possible.
    Otherwise, the more production cycles you miss, the more you can't bear it, and you will lose your trust in customers
    .
    "


    Over time, overseas customers will feel very insecure and may turn to the arms of companies from other countries
    .
    "Because (they) feel that it is handed over to Chinese companies for production, the risk of delays brought about by epidemic control is too great
    .
    " He added that a hidden concern has also surfaced - part of the international reputation of Chinese pharmaceutical companies may be damaged.
    In the past two years The impression that the established supply chain is stable may also be called into question
    .


    The resumption of work and production is imminent, and the policy call is coming
    .
    How far have the biopharmaceutical companies involved in the "Guidelines" on April 16 now resumed production and work?


    Ten days after the introduction of the policy, a foreign company said that it has now overcome many prevention and control requirements and has begun to resume work
    .


    Many pharmaceutical companies have stated that the biggest difficulty now is the community isolation policy, and employees cannot go out of their homes
    .
    Even if you can get out of the house, the road condition control is also a problem.
    "It used to take up to an hour or two on the way to work, but now the journey has become particularly long and long
    .
    " In addition, in order to meet production standards, the production sites of some pharmaceutical companies have strict regulations on the size and cleaning standards of the sites, which cannot meet the requirements of prevention and control.
    This is an urgent problem for them to resume work
    .


    Some employees of pharmaceutical companies said that they had not received a specific notice on how to resume work, and said that their arrangements for the resumption of work were relatively limited, and government-led organizations and arrangements were needed
    .
    "At present, except for the closed management of the business in the factory area, the others are still suspended
    .
    " The employee is still worried about how this policy will be implemented
    .


    If the above is just a chain reaction at the product (drug) level, there is a more far-reaching impact from the talents behind product development
    .
    Several interviewees were worried: "Are the R&D personnel unwilling to come back in the future?" They observed that foreign scientific research talents began to hesitate to return to China
    .
    Some say the overseas scientists he has contacted are continuing to wait and see
    .
    Others said that they even flashed the idea of ​​"regret returning to China" at one point
    .


    If talent is lost, it will be a dilemma for innovative pharmaceutical companies
    .


    Because of the surging of China's innovative drugs, it can be traced back to the wave of returnees from overseas that began in 2001, and it took off on the flywheel of talent dividends
    .
    Today, the founders or executives of many domestic biotechs have almost the standard background of overseas scientists
    .
    For a long time, Shanghai, especially Zhangjiang Medicine Valley, has been a favorite place for returnees to start a business
    .


    In the view of a pharmaceutical company R&D personnel, if the wave of brain drain hits, it is bound to have an impact on the development of innovative pharmaceutical companies
    .
    Biotech continues to be in the doldrums in the secondary market, and the two major bargaining swords of "medical insurance + centralized procurement" hang overhead, and companies are desperately looking for money to maintain astronomical R&D investment
    .
    Now the epidemic has shut down production and production, which has made biotech's already difficult life even worse
    .


    In the early years, pharmaceutical companies that were rich and spent a lot of money to attract talents have gradually offered prices in recent years on par with foreign countries
    .
    The "severe cold" in the secondary market is transmitted to the primary market, and investors have less money and are cautious about investing
    .
    "The money given is less, and the epidemic prevention policy is uncertain.
    It is better to 'be consistent' overseas
    .
    Although the climb is not too high, it is stable
    .
    " The above-mentioned industry insiders gave such an analysis of the current situation
    .


    It is undeniable that without the return of overseas talents, the development of domestic biotech may become difficult
    .
    Domestic biomedicine is mainly fast-follow, and its international strength is far less than that of the domestic pharmaceutical industry, IT and chemical industries.
    Best-in-class and first-in-class still require experienced researchers to lead the way
    .


    The industry has predicted that in another 10 years, the development of China's biopharmaceutical industry will be second only to the United States
    .


    "But now, if we can't retain or attract talents, it may be an extravagant hope that we can catch up with Europe and Japan
    .
    " This is a blow from the bottom of the pot
    .


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