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Looking back on 2022, although China's biomedical industry is shrouded in "cold air", it has finally crossed another cycle in the grandeur and ended another year of
journey.
By sorting out GBI
SOURCE database released news throughout the year user views, news tags and other information, Xiao G sorted out the following medical industry keywords in 2022, let's officially bid farewell to 2022 in the review, hope for 2023
.
01 Enterprise "going to sea"
01 Enterprise "going to sea""Going to sea" is undoubtedly one of
the hottest words that will attract the most attention in the industry in 2022.
However, under multiple challenges such as R&D, capital, talents, and access, the results of local innovative pharmaceutical companies' "going overseas" are mixed.
"Cardiotonic agents" such as the legendary biological CAR-T cell therapy CARVYKTI (Cedarki Cel) were approved for marketing in the United States, the European Union and Japan in February, May and September respectively; BeiGene's BRUKINSA (zebrutinib) has been approved in 58 markets including the United States, China, the European Union, the United Kingdom, Canada, Australia and South Korea; The License-out record of domestic innovative drugs has been continuously refreshed
.
"Heavy blows" such as domestic PD-1 "going to sea" The United States has suffered setbacks one after another: Cindarbaboshu (Cindilimab) was rejected due to the lack of MRCT data that could represent American patients, and Baekje Bazean (tirelizumab) and Junshi Tuoyi (teripulimab) were temporarily hindered due to the epidemic
.
Fortunately, the journey of twists and turns is accompanied by a ray of hope: in November 2022, Henlius' Hans-like (serplulimab) bridging study in the United States completed the first drug administration; In December, EMA accepted Junshi Tuoyi's marketing authorization application; East China Pharmaceutical, Tonghua Dongbao Liraglutide injection have comprehensively expanded into emerging countries such as the Middle East and North Africa.
.
.
Although "going to sea" is not a smooth road, it is the only way
.
02 "Slimming"
02 "Slimming"Affected by the global economy, geopolitics, and the new crown epidemic, many MNC performance is under pressure, and they continue to carry out "slimming" transformation by streamlining their organizational structure and selling non-core businesses.
In April 2022, Novartis launched a simpler organizational model, planning to integrate the pharmaceutical and oncology business units, and merge the three divisions of corporate strategy, R&D portfolio strategy and business development.
In August, Novartis announced the spin-off of Sandoz into a new independent public company; In December, ophthalmic pharmaceutical company Harrow
Health announced that it will acquire exclusive U.
S.
commercialization rights
for five Novartis ophthalmic products.
In April 2022, Daiichi Sankyo announced the transfer of 100% of the shares of Daiichi Sankyo Pharmaceutical (Beijing) Company and the product rights of its products Colabital tablets and injections in Chinese mainland to Chongqing Yaoyou Pharmaceutical, a subsidiary of Fosun Group, with follow-up plans to focus on oncology business
.
In July 2022, Pfizer decided to make structural adjustments in three aspects: biopharma, global product development (GPD) and business innovation (CBIO) to focus more on the new crown vaccine Comirnaty and the new crown oral drug Paxlovid
.
In July 2022, GlaxoSmithKline (GSK) officially completed the spin-off of its consumer healthcare business and named the new company Haleon
.
In addition, the consumer health business spin-off plan announced by Johnson & Johnson in November 2021 is also expected to be implemented
this year.
03 New crown drugs
03 New crown drugsIn 2022, the world is still shrouded in the haze of "Omicron", making the progress of new crown drugs and devices related to it a hot topic in the industry——
In terms of vaccines, in early December 2022, with 4 domestic new crown vaccines approved for emergency use within 3 days, 13 new crown vaccines in China have been approved for conditional marketing or included in emergency use
.
In addition, 10 mRNA vaccines developed by domestic enterprises are in the clinical stage
.
In terms of small molecule drugs, in July 2022, Real Bio Azvudine was approved for COVID-19 indication, which is the first domestic new crown small molecule drug approved; In September, Azvudine and Pfizer Paxlovid (nematevir tablets/ritonavir tablets) entered the list of drugs through the formal review of the adjustment of the national medical insurance catalog in 2022; At the end of December, the State Food and Drug Administration approved the import registration of MSD monoravir capsules with emergency conditions, and Junshi Biologics VV116 announced the gratifying clinical results
of phase III compared with Paxlovid in the treatment of mild to moderate patients.
In addition, there are nearly 20 small molecule drugs under development
.
In terms of antibody drugs, in addition to the marketed Tengsheng Bo drug new crown neutralizing antibody ambavirumab/romisivimab (BRII-196/BRII-198), nearly 20 drugs are in the early stage
of clinical trials at home and abroad.
In terms of new crown antigen test agents, according to GBI
DEVINT medical device database, as of December 30, 2022, there are as many as 50 new crown antigen detection products listed in China
.
04 "Winter"
04 "Winter"In 2022, the biotechs with unlimited scenery at that time encountered a "cold winter", and had to face practical problems such as weak product competitiveness, insufficient hematopoietic capacity, and worrying commercialization prospects at home and abroad, and actively carried out "self-help"——
In June 2022, Watson Biologics terminated clinical studies of recombinant EV71 vaccine due to the foreseeable low social and economic benefits of the product; In August, Genting Xinyao "cut meat" core product TROP-2
ADC gosatuzumab to "return blood to life"; In November, CStone announced that it had decided to discontinue trial operation of the Suzhou plant, considering that it was still in the trial operation
stage and there was no clear large-scale production demand in the near future.
In addition, I-Mab and CStone were reported to be willing to "sell" themselves in April and July
.
There are also biotech that have obtained bright benefits
through "open source hematopoiesis".
In the first half of 2022, Henlius and Getz
Pharma, Eurofarma and Abbott partnered on Handayuan, Hanlikang, Hanquyou and Hambeit, respectively, and the HLX11 and HLX14 transactions with Organon generated an additional $541 million in potential revenue
in June.
According to Henlius' financial report, the company's operating income in the first half of 2022 increased by about 103.
5%
compared with the same period last year.
The external licensing revenue provides sufficient "backing"
for the company's innovation project research and development and internationalization journey.
05 "Exhaustion should be taken"
05 "Exhaustion should be taken"On January 10, 2022, Premier Li Keqiang presided over the executive meeting of the State Council, proposing to promote the normalization and institutionalization of centralized procurement and accelerate the expansion of coverage to benefit patients
.
The meeting confirmed that by the end of 2022, the total number of national and provincial centralized procurement drugs in each province will reach more than 350; Further expand the centralized procurement of high-value medical consumables; Strengthen supervision to ensure that the price of selected products does not decrease in quality
.
In July 2022, the seventh batch of national centralized drug procurement landed
.
The final transaction price of 60 drugs with a total market size of more than 20 billion yuan was about 4.
4 billion yuan.
The collection involved 31 disease categories in 10 therapeutic areas, among which the average reduction rate of antitumor drugs was the highest, reaching 85% (calculated by the highest effective quotation).
In 2022, the variety of medical consumables will gradually expand from high-value medical consumables to common medical consumables
.
In October, Fujian led the joint procurement of medical consumables such as electrophysiology and laparoscopic stapler, and Hebei Province planned to carry out the centralized procurement of 20 kinds of medical consumables, such as artificial bone filling materials, and OK mirrors were prominently listed
.
In addition, Hebei, Jiangsu and Fujian have completed the centralized procurement
of spring coil medical consumables.
In 2022, the state's supervision of selected products in centralized procurement will become stricter
.
In February, the production and sales of the second batch of selected products of national centralized procurement of glimepiride tablets were suspended, and Shengjitang Pharmaceutical was included in the "violation list"; In June, the fifth batch of bicalutamide tablets produced by India Sun Pharmaceutical was disqualified; In November, GSK's fifth batch of selected drugs for centralized procurement of drugs under GSK was disqualified, GSK was included in the "illegal list", and the qualification
to participate in national procurement was suspended for one and a half years.
06 Patent Wars
06 Patent WarsThe implementation of the new patent law in June 2021 and the drug patent linkage system in July 2021 have created a new legal and regulatory environment
for the trading of new drugs.
In 2022, the "patent war" of the original research V.
S.
generic drug companies will continue -
In August 2022, China's first pharmaceutical patent linkage litigation case lasted 8 months and the final judgment of the second instance
.
The Supreme People's Court ruled that the technical solution of the generic drug (idecalcidol) involved in the case did not fall within the scope of protection of the patent right in question, and the appeal request of the plaintiff Sino-foreign Pharmaceutical Co.
, Ltd.
could not be established and should be rejected
.
The pronouncement of the judgment of this case is a milestone
in the implementation of China's pharmaceutical patent linkage system.
In October 2022, the first generic drug of mabaloxavir of CSPC was approved for marketing
by the State Food and Drug Administration.
In this regard, mabaloxavir original research Roche Pharmaceutical issued a relevant statement
.
Roche said that it had communicated with Ouyi on intellectual property issues many times, but on the one hand, Ouyi believed that its approved generic drugs fell within the scope of protection of the Chinese invention patent No.
ZL201180056716.
8, and on the other hand, refused to promise not to infringe patent rights during the above-mentioned patent protection period
.
For the application of Ouyi for the listing of generic drugs, the patentee has filed a patent linkage lawsuit
.
In November 2022, Shanghai Sunshine Pharmaceutical Procurement Network announced the suspension of the procurement qualification of
lindagliptin tablets produced by Guangdong East Sunshine Pharmaceutical Co.
, Ltd.
It is reported that the first generic of Dongguang Pharmaceutical Lidagliptin was approved in July 2020, and since February 2021, it has been successively publicized on the drug procurement platform in many provinces and promised to be sold to medical institutions, which has also attracted the attention of the original research enterprise Boehringer Ingelheim, and launched infringement lawsuits
against generic drug companies.
In July 2022, the case ended
with the State Intellectual Property Office convicting East Sunshine for infringing a Boehringer Ingelheim patent protecting lintagliptin compounds.
07 "Great Access"
07 "Great Access"In the new ecological environment of deepening medical reform and value-based medical care, pharmaceutical companies have gradually transitioned from the competition of conventional business models to the competition
of "market access".
Many MNCs have gradually improved the access organizational structure, such as the integration of multi-channel access functions by Division N, and the access strategy covers a wide range; Division A is GAMA and KA together, and each has a more mature access team; Another example is the R Division, which has added an innovative payment team as a strong support
for market access.
"Great access" is the trend of the times
.
Conversations with industry insiders found that companies with good access have set up a relatively complete central strategy and central operation team, focusing on integrating multi-channel access functions, such as KA, bidding, patients, innovative payment, commercial insurance, etc.
; Secondly, some enterprises have set up access BPs specifically to support each BU, or will set up access project execution teams in the marketing and sales of BU; In addition, as the country successively introduces relevant policies to encourage the development of commercial insurance, enterprises will add innovative projects or related strategic functions to better support access work
.
08 ADC trading
08 ADC tradingFocusing on license-out transactions in the first half of 2022, the entire ADC drug transaction accounted for 15% of the total therapeutic area, second only to monoclonal antibodies (27%) and small molecules (23%)
.
In 2022, Merck repeatedly entered into cooperation with Kelun Pharmaceutical on ADC products, including acquiring the global rights of two ADCs (SKB264 and SKB315) of Kelun Pharmaceutical for more than US$2.
3 billion, and announcing in December that it has partnered with Kelun Pharmaceutical's subsidiary Kelun Patai to develop seven preclinical ADC drugs
for the treatment of cancer.
The latter set a new license-out record
in China with milestone payments totaling no more than $9.
3 billion.
In addition, in June 2022, Duoxi Biologics also entered into ADC-related cooperation with Johnson & Johnson subsidiary Janssen, according to the agreement, Duoxi Biologics will use its unique ADC innovation platform and Janssen's unique antibodies to develop novel ADC drugs
for up to 5 targets.
Johnson & Johnson helped facilitate the agreement, and JJDC, an investment arm of Johnson & Johnson, also made an equity investment in
Duoxi Biologics.
09 Digital transformation
09 Digital transformationIn addition to streamlining the architecture and saving costs for better agile transformation, MNC has also continued to cultivate
in the field of digitalization in recent years.
In June 2022, AstraZeneca announced the establishment of a new CCiC innovation management team, and the original innovation market positions of each business unit will be officially transferred to the CCiC innovative disease management team of the Digital and Business Innovation Department, forming a business innovation team
based on the therapeutic field and omni-channel.
This move may be an important signal
for its comprehensive layout in the digital field.
During the 5th CIIE in November 2022, many MNC also reached a number of cooperation in the field of digitalization: Novartis China and Alibaba Health once again upgraded the cooperation content, jointly adhering to the concept of "patient-centered", continuously expanding patients' access to medication through digitalization, and providing patients with one-stop health management services; Takeda collaborated with Amazon Web Services and Accenture to jointly explore the construction of a full-cycle industrial cooperation model from incubation to commercialization in the field of digital healthcare.
Organon cooperated with Alibaba Health to jointly explore the innovation of "Internet +" chronic disease management model, jointly empower online diagnosis and treatment and disease management ecology, and improve patient compliance with diagnosis and treatment
.
10 Innovative payments
10 Innovative paymentsAs an important part of the multi-level medical security system, commercial health insurance plays a key role in meeting diversified medical service needs and supporting the sustainable and healthy development of the domestic innovative drug industry, and has gradually attracted extensive attention
from industry-related practitioners.
At present, there have been many explorations
in China to combine commercial health insurance with the pharmaceutical industry.
For example, the liability for special drug protection has gradually become the standard for medical insurance in the industry, and more and more insurance companies have begun to pay attention to and keep up with the latest therapies, drugs and technologies, and incorporate them into
innovative products.
Another example is to combine the installment payment of drugs purchased by patients with insurance to ease their payment pressure, improve the conversion rate of prescriptions and the efficiency
of all parties.
In addition, inclusive commercial medical insurance strongly supported by the government is also continuing to develop
.
According to online public information, as of the end of June 2022, a total of 27 provinces across the country are implementing 167 inclusive commercial medical insurance plans
.
More and more overseas special drugs are included in local inclusive insurance
.
In May 2022, Lecheng Special Pharmaceutical Insurance reached a cooperation agreement with "Longjiang Huimin Insurance", which has become another new achievement
of cross-provincial cooperation and linkage innovation after entering Beijing, Shanxi, Hunan, Hebei, Hubei Suizhou, Gansu Lanzhou, Guangdong Zhanjiang, Inner Mongolia, Shanghai, Qinghai Xining and other places.
In September, Heilongjiang's first inclusive insurance "Longjiang Huimin Insurance" was launched, including 26 overseas special drugs
.
Whether light or dark, the old chapter of 2022 has ended, and what awaits China's biomedical industry is a new chapter
in 2023 that is still full of hope and challenges.
Let us continue to move forward hand in hand, witness in anticipation, and grow
in witness.
