This is the best of times for biopharmaceutical CDMOs; this is the worst of times for biopharmaceutical CDMOs.
Release Date:
2022-05-08 11:00
It’s year-end again—looking back 2021 Over the past year, the domestic biopharmaceutical CDMO sector has witnessed a remarkably dynamic and diverse landscape. Some companies have been acquired, others have secured substantial financing to continuously expand production capacity, some have attracted equity investments from listed firms, and several publicly listed pharmaceutical companies have embarked on strategic transformations to focus on biologics. CDMO , some enterprises have already submitted Initial Public Offering Applications have been accepted; some companies are currently receiving guidance on the path to an IPO, and local industrial parks have also been developed for biopharmaceuticals. CDMO Platform recruitment Some are handed over to professional teams for operation, while others... Biopharm Enterprise opening First entering the biopharmaceutical field CDMO . At present, we can only use “ Extreme involution ”,“ Unprecedented prosperity “To describe domestic biopharmaceuticals” CDMO The development of the industry.
CDMO ( Contract Development Manufacturing Organization ) is a comprehensive pharmaceutical development program based on the client’s project ( Chemical Manufacturing and Control ), encompassing everything from early-stage molecular design and construction, process development, and quality attribute studies, all the way to the production of clinical trial samples for drugs. Biologics CDMO Our services primarily encompass cell line development related to cell culture, optimization of cell culture processes, antibody expression and pilot-scale production, quality control, as well as commercial-scale antibody manufacturing and formulation.
Biologic drug CDMO Typical of Capital-intensive Industry, building in accordance with Good Manufacturing Practice The required production facilities entail substantial capital investment and typically demand significant upfront capital support as well as the recruitment of a robust talent pipeline. In August 2015, the State Council issued the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices,” which, for the first time, proposed to launch MAH Pilot work on the system. MAH The system is a management model that separates drug marketing authorization from manufacturing license. The primary intention behind it was to Promote innovation in the pharmaceutical industry and improve capacity utilization. and other aspects to leverage the role of policy. However, based on the current situation of domestic biopharmaceutical companies, most R&D firms in the biopharmaceutical sector are considering building their own manufacturing facilities, while domestically produced biopharmaceuticals CDMO Companies are continuously expanding their production capacity, creating a sort of capacity arms race. According to various biopharmaceutical firms, CDMO Financing announcement: preliminary statistics on domestic biopharmaceuticals CDMO The total investment in the track has exceeded RMB 10 billion.
Biologic drug CDMO Enterprise The projects come from outsourcing by biopharmaceutical R&D companies; perhaps the real challenge lies in addressing the pain points these companies face in biopharmaceutical R&D. CDMO The enterprise has not To be able to emerge victorious in this battle of champions. What are the pain points faced by biopharmaceutical R&D companies?
1. Homogenization of R&D projects , for example Cluadin 18.2 Currently, a total of 20 drugs worldwide have entered the clinical phase, with 17 developed by domestic companies and 19 undergoing clinical trials in China.
2. Lack of a talent team ， discover The founding team has strong capabilities in molecular discovery, but lacks CMC Skilled professionals are essential; the entire drug-development process requires close collaboration among many experienced experts to bring a drug to market.
3. Cash-strapped In recent years, objective factors such as rising labor costs, supply-chain disruptions caused by the pandemic, and a sharp surge in the price of crab-eating macaques—non-clinical experimental animals—have led to a steep increase in drug-development costs, inevitably straining companies’ financial resources.
4. Pressure to control costs through centralized procurement Each year, during the national medical insurance negotiations, every pharmaceutical company strives to have its products included in the national reimbursement directory; however, companies whose drugs are subject to price reductions through centralized procurement must not face increased costs. Accounting. For example, In the sixth round of national centralized drug procurement (insulin-specific), the shortlisted products are: The average price reduction exceeds 48%.
The same applies to biologics. CDMO The enterprise comes. To maintain market competitiveness, the following aspects must be considered:
1. A Clear Vision and Mission for the Enterprise , biopharmaceuticals CDMO At its core, the business provides technical services to help clients overcome project challenges; only by successfully delivering projects can we ensure our own sustainability. For companies that are expected to both develop their own products and undertake client projects, CDMO How can enterprises strike the right balance between internal and external relationships, and what, ultimately, are their vision and mission?
2. A stable mid-level team , a reliable and stable team is the foundation for ensuring timely and quality project delivery. In China, some CDMO
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