Stock price dives, R&D burns money, biopharmaceutical companies move forward tenaciously in 2021

On December 15, 2021, BeiGene’s first day of listing on the Science and Technology Innovation Board broke, and in the following 10 trading days, the stock price fell by nearly 25% from the issue price
.
Amid all kinds of doubts, the star company is still advancing various tasks as planned
.
In the days after the listing, BeiGene successively announced the opening of the "BeiGene Bio-Island Innovation Center", reached a cooperation agreement with Novartis on the TIGI T inhibitor Ociperlimab, and officially supplied the neuroblastoma treatment drug Kaiser
.
BeiGene's experience seems to be a portrayal of the development of China's biopharmaceutical industry in 2021 - creating and seizing opportunities with a tenacious attitude in the treacherous and ever-changing market environment
.
Wind data shows that in 2021, the stock prices of A-share biopharmaceutical companies will drop by an average of 5.
51%.
Behind the shock and adjustment of the capital market is the dilemma faced by domestic biopharmaceutical companies in a new stage of development-intensified homogenization, centralized procurement varieties are under pressure , and some product research and development has reached the "no man's land" in the world
.
Solving development problems with technological innovation has become a common choice for biopharmaceutical companies
.
Breakthroughs in therapeutic areas never stop CAR-T products are coming
.
In June 2021, Fosun Kite Biotechnology Co.
, Ltd.
(hereinafter referred to as "Fosun Kite"), the first domestic autologous CAR-T product, Akilunsai Injection, was approved for listing through the priority review and approval process
.
However, due to the high price of the product, the Akilence injection that passed the preliminary form review ultimately failed to qualify for medical insurance
.
How does cell therapy achieve accessibility? In this regard, relevant biopharmaceutical companies have conducted useful explorations
.
At the end of December 2021, Beiheng Bio disclosed that its self-developed general-purpose CAR-T product clinical trial application was accepted
.
According to the company's official website, compared with autologous CAR-T products, general-purpose CAR-T products are prepared from T cells from healthy people, and patients undergoing cell therapy do not need to be matched.
The universality, timeliness and economy of the product Significant improvement, and the production of general-purpose CAR-T products is more stable and relatively more competitive
.
In addition to making a fuss about T cells, NK cells have also become another option for immunotherapy.
Wang Liqun, the former CEO of Fosun Kite, established Xing Yiang Biotechnology Co.
, Ltd.
, focusing on research and development with higher safety, lower preparation cost and better applicability Good CAR-NK product
.
Pharmaceutical companies in other therapeutic areas are also looking for innovative breakthroughs in efficacy, safety, and delivery methods
.
In March 2021, Longpei somatotropin developed by Weisheng Pharmaceuticals has successfully completed the patient enrollment.
The drug can release the same unmodified parent drug as the human body's own hormones.
The drug has stronger local tissue penetration and better affinity with the human body; at the end of November 2021, the world's first subcutaneously injected PD-L1 antibody jointly promoted by Corning Jereh, Sidi Pharmaceuticals and Simcere Pharmaceuticals The drug envolizumab injection was approved for marketing, benefiting from an innovative nano-dosage form, which shortens the duration of immunotherapy from 0.
5 to 2 hours of traditional intravenous injection to less than 30 seconds
.
According to statistics, a total of 12 domestic innovative organisms (including vaccines) have been approved for marketing in 2021
.
In therapeutic areas with unmet needs, innovative biologics show great potential and appeal
.
Strong research and development strength is more favored by capital Wind data shows that from 2018 to 2020, A-share biopharmaceutical companies invested an average of 296 million yuan in research and development each year, much higher than the 146 million yuan of the entire pharmaceutical industry
.
In the first half of 2021, A-share biopharmaceutical companies continued to increase their investment in research and development, with an average increase of 55.
48% over the same period of the previous year
.
On the whole, those with strong R&D strength are more likely to be favored by capital
.
Taking BeiGene as an example, the research and development expenses in the first half of 2021 alone will be as high as 4.
151 billion yuan, ranking first in A-shares.
BeiGene has also refreshed the scale of domestic biopharmaceutical companies’ listing and fundraising with 20 billion yuan
.
Northland, a gene therapy drug research and development company, also submitted its first refinancing application to the Beijing Stock Exchange, planning to raise no more than 300 million yuan from specific targets, attracting more than 20 investment institutions to investigate
.
According to reports, Northland's core product under development, NL003 (recombinant human hepatocyte growth factor naked plasmid injection), is progressing in an orderly manner in phase III clinical trials, and plans to submit a marketing application in 2022
.
Behind the orderly advancement of core products is the company's high R&D investment for several years
.
Northland's R&D expense ratio (the ratio of R&D expenses to main business income) is always above 50%
.
This company, which often relies on technology transfer to "live", finally gained popularity in the capital market in 2021.
The company's stock price rose 151.
47% throughout the year, breaking the dullness since its listing in 2009, ranking first among listed biopharmaceutical companies
.
According to public information, biopharmaceutical companies that maintain high R&D investment for many years are often more likely to gain investor recognition (see figure)
.
The average R&D expense ratio of biopharmaceutical companies with rising stock prices in 2021 from 2018 to 2020 is 28.
6%, which is much higher than the average R&D expense ratio of 6.
81% for biopharmaceutical companies whose stock prices have fallen in 2021
.
Outside the stock market, more biopharmaceutical companies are also growing rapidly with the help of private equity (PE) and venture capital (VC)
.
According to the Wind China Private Equity Venture Capital (PEVC) library, in 2021, there will be more than 220 PE/VC financing events of domestic "biotech" companies
.
Aibo Bio, which owns the intellectual property rights of mRNA and nano-delivery technology platforms, completed financing of 600 million yuan, 720 million US dollars and 300 million US dollars in April, August and November 2021, of which 720 million was completed in August.
The USD C round of financing has set a new record for a single round of PE/VC financing for biotech companies in the past three years
.
Cost control may become the key to enterprise competition On December 3, 2021, the National Medical Security Administration announced the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2021)" (hereinafter referred to as the 2021 Medical Insurance Catalog), Hengrui Medicine , BeiGene, Innovent Bio and Junshi Bio’s Camrelizumab Injection, Tislelizumab Injection (Bai Ze’an), Sintilimab Injection, Toripalimab Part of the indications for injections will be included in the 2021 medical insurance catalog with price cuts after medical insurance negotiation
.
The price of PD-1 products in the competition in the Red Sea continues to decrease, and the willingness of enterprises to control costs is stronger
.
In addition, the increased volume of medical insurance also puts forward requirements on the supply capacity of enterprises
.
Taking Baizean as an example, in the first half of 2021, the sales revenue of Baizean, which has been included in the medical insurance catalogue, was US$124 million, an increase of 147.
8% compared with the same period in 2020 when it was not included in the medical insurance catalogue.
, sales increased significantly
.
Driven by profitability requirements and market demand, PD-1 pharmaceutical companies have strengthened their biologics production capacity
.
In April 2021, BeiGene's Guangzhou biopharmaceutical production base started commercial production and supply, and the first batch of 8,000 liters of production capacity approved for commercial production was used to produce Baizean, which further increased the cost and cost of Baizean.
The ability to control supply
.
Weisheng Pharmaceutical in the field of endocrinology announced in May 2021 to build a R&D and manufacturing base in Suzhou Industrial Park for the localized production of the company's related innovative products to control costs and ensure supply; Northland in the field of gene therapy 2021 In October 2018, it announced that it plans to invest 450 million yuan to build an intelligent bioengineering drug production base, which will carry the research and development, production and commercialization tasks of a number of core drugs including NL003 in the future
.
In addition, WuXi Biologics, the leading biopharmaceutical contract R&D and manufacturing organization (CDMO), is also accelerating the integration of biological product production capacity.
In May 2021, it completed the acquisition of Pfizer China's original solution and preparation production base in Hangzhou and the CDMO company Suqiao Biologics.
, the scale effect is further enhanced
.
Perhaps the biopharmaceutical companies that eliminate the "middlemen" will gain more obvious cost advantages and clearer supply capabilities, and seize the first opportunity in the future market competition
.