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The competition in the domestic PD-1 market is becoming increasingly intense, the 100 billion market is chasing the deer, the leaders are involving new indications, and the new entrants are doing their best
.
Who killed the deer? A few days ago, the domestic PD-1 "Four Tigers" Hengrui Pharmaceutical, BeiGene, Junshi Biologics, and Innovent Biologics successively announced their financial results
for the third quarter of 2022.
Once medicine took you to take
stock one by one.
1 On performance: BeiGene is temporarily ahead
1 On performance: BeiGene is temporarily aheadOn November 9, BeiGene's third-quarter earnings were long overdue
.
So far, the sales results of the domestic PD-1 "Four Little Tigers" Q3 have surfaced
.
Junshi Biologics: Revenue in the third quarter was 272 million yuan, down 54.
91% year-on-year, and total revenue in the first three quarters was 1.
218 billion yuan, down 55.
18%
year-on-year.
Among them, the sales revenue of teripulimab injection (Tuoyi) in the third quarter was about 218 million yuan, accounting for about 80.
15% of Junshi Bio's revenue in the third quarter, and the total sales of Tuoyi ® ® in the first three quarters were 516 million yuan, achieving three consecutive quarters of sequential growth
.
15% of Junshi Biologics' revenue in the third quarter
Innovent Biologics: Total revenue reached CNY 1.
1 billion
in the third quarter.
Among them, the sales volume and revenue of Cindilimab injection (Daboshu) ® achieved quarter-on-quarter growth, but the specific figures
were not disclosed in the financial report.
According to its partner Eli Lilly's financial report, in the first quarter of this year, Innovent Biologics Daboshu's ® sales were 85 million US dollars, about 570 million yuan, down 22% year-on-year; Second-quarter sales were US$73.
6 million, or approximately RMB490 million, down 30% year-on-year; Third-quarter sales were US$77 million, or approximately RMB560
million.
In the first three quarters, the total sales of Daboshu ® were about 1.
66 billion yuan
.
66 billion yuan
Hengrui Pharmaceutical: In the third quarter, the company achieved revenue of 5.
717 billion yuan, a year-on-year decrease of 17.
16%; achieved a net profit of 1.
054 billion yuan, a year-on-year decrease of 31.
54%; Net profit excluding non-recurring profit and loss was RMB1.
042 billion, down RMB3.
059 billion
year-on-year.
However, the company did not disclose carrelizumab (Erica ®) sales
.
BeiGene: Revenue of 26.
59 in the third quarter
100 million yuan, PD-1 tislelizumab in the third quarter continued to increase, with sales reaching 879 million yuan
.
According to the data of the previous half-year report, Baizean's ® sales in the Chinese market reached 1.
251 billion yuan, a year-on-year increase of 56.
3%.
In the first three quarters, the total sales of Baizean ® ® reached 2.
13 billion yuan
.
In addition to Hengrui Pharmaceutical's "secret", as the earliest PD-1 product listed in China, Baizean's ® performance is currently in a leading position, and the number of approved indications is also among the best
.
As of October 2022, 9 indications have been approved in China and 5 indications have been included in medical insurance, which is currently the PD-1 drug
with the most approved indications in China and the most indications included in the medical insurance catalog.
A marketing application has been filed for the 10th indication for the combination chemotherapy and first-line treatment of patients with advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with tumors expressing PD-L1
.
.
In terms of the layout of the global market, Bazean ® has submitted new drug marketing applications in many countries, including the United States, Europe, the United Kingdom, Australia, New Zealand, South Korea, Switzerland, etc.
, covering esophageal squamous cell carcinoma (ESCC), non-small cell lung cancer (NSCLC) and other important fields
.
up to
In the third quarter of 2022, more than 11,500 global clinical development projects have ® been enrolled in 30 countries and regions
subjects
.
In addition, Bazean is also the only PD-1 antibody drug
in China that has submitted a marketing application to the European Medicines Agency (EMA).
Junshi Biotech's ® sales also showed a steady upward trend, gradually becoming the company's main product
.
With the acceleration of commercialization, Junshi Biologics expanded its sales team in the first half of the year, and Tuoyi's ® sales began to increase
steadily.
After the implementation of the new version of the medical insurance catalog, Innovent Biologics Daboshu ® was inevitably affected by the price, and its performance fell seriously
year-on-year.
However, the rapid growth of sales of this product has enabled Cinda product revenue to still achieve overall growth
.
2 On competition: the new indications are more volatile
2 On competition: the new indications are more volatileThe 2022 medical insurance negotiations are imminent, and a total of 7 domestic PD-1/PD-L1 drugs are participating in the negotiations
.
They are the PD-1 monoclonal antibody of Hengrui Pharmaceutical, BeiGene, Innovent Biologics and Junshi Biologics, which are already in medical insurance, and the PD-L1 monoclonal antibody jointly developed by Akeso Biologics PD-1/CTLA-4 dual antibody, Henlius PD-1 monoclonal
antibody, and Corning Jerry/Sidi / Simcere Pharmaceutical.
In addition to the approved indications, major pharmaceutical companies are also competing for new indications
for their products.
According to the information released in the preliminary review list, products of Junshi , Cinda, Hengrui and BeiGene have all entered the preliminary review list
of the adjustment of the medical insurance catalogue under condition 2 of the catalogue (drugs approved by the national drug administration between January 1, 2017 and June 30, 2022, with significant changes in indications or functional indications).
According to the approval of the latest indication of PD-1 of various pharmaceutical companies, the "four tigers" may all fight for the first-line treatment indications of advanced esophageal squamous cell carcinoma
.
In addition, BeiGene, Hengrui and Junshi will also compete on the same stage for first-line nasopharyngeal cancer treatment indications
.
(Image source: Insight database)
The competition for the expansion of indications outside of medical insurance negotiations is also continuing
.
Innovent disclosed in its semi-annual report that it has conducted more than 20 clinical studies on Daboshu ® to evaluate its safety and efficacy for a wide range of cancer indications, including eight registered or pivotal clinical trials
.
Three of these trials evaluated Daboshu for second-line squamous non-small cell lung cancer, first-line squamous non-small cell lung cancer and first-line non-squamous non-small cell lung cancer, and patient recruitment
has been completed.
Similarly, Hengrui Pharmaceutical's Erica ® is also opening up indications
.
Hengrui Pharmaceutical said on its official website that the company is carrying out 29 studies in China to evaluate Erica alone or in combination with different treatments, of which the phase III clinical study for the treatment of advanced esophageal squamous cell carcinoma has been completed, and the indication of hepatocellular carcinoma has applied for marketing based on the efficacy and safety data obtained from phase II clinical trials and has been accepted by CDE, and has been included in the list
of varieties to be prioritized for review.
Junshi Biologics also said that in the first half of this year, 11 single-agent or combination drug studies have been carried out for phase II/III key clinical trials
of advanced melanoma, advanced esophageal cancer, adjuvant therapy for advanced liver cancer, non-small cell lung cancer, advanced nasopharyngeal carcinoma and advanced urothelial cancer.
In addition, on October 31, Junshi Biotech was registered and publicized in China
First clinical trial
of JS001SC.
This is the second subcutaneous injection of PD-1 monoclonal antibody
into the clinic in China.
JS001sc
The injection is a subcutaneous injection preparation
developed by Junshi Biologics on the basis of the marketed PD-1 product Topilimab ® injection.
The development of its superior PD-1 product into subcutaneous preparation, foreign research
as early as 2015.
Year 8
Last month, Roche just announced a Phase III clinical trial of a subcutaneous formulation of atezolizumab (Tecentriq) in patients with locally advanced/metastatic NSCLC who have failed platinum-based therapy who have not received immuno-oncology
The IMscin001 study met a common primary endpoint and was non-inferior to marketed intravenous PD-L1 monoclonal antibody
Tecentriq
。 As early as last year, the subcutaneous injection SHR-1901 developed by Hengrui Pharmaceutical based on carrelizumab Erica ® has also started clinical trials
.
3 On pressure: New players are menacing
3 On pressure: New players are menacingAccording to IQVIA data, there have been more than 5600 clinical trials for PD-1/PD-L1 inhibitors worldwide
.
Over the past 5 years, PD-1/PD-L1 checkpoint inhibitors have been one of the most dynamic market segments, significantly outperforming the global antineoplastic drug market, with a 5-year compound growth rate of 45%, which is 3 times
the overall growth rate of antineoplastic drugs.
As the PD-1/PD-L1 market matures, global sales of PD-1/PD-L1 inhibitors are expected to reach US$58 billion (approximately RMB 400 billion)
by 2025.
In the 100 billion market, newly promoted domestic PD-1 players have done their best to walk out of the road
of differentiated competition.
Among them, Akeso Biopharma is the most competitive
.
Akeso's product sales amounted to 297 ® million yuan
in the first half of the year.
Through the drug donation plan, the two-year cap treatment cost is as low as 39,000 yuan, which is the lowest quotation among the PD-1 products currently listed in China
.
The self-developed PD-1/CTLA-4 bispecific antibody new drug (cardunilimab injection, trade name: Kaitanil), ® the company disclosed the information
of receiving nearly 100 million yuan in advance in early July.
Katanil ® is the world's first PD-1 product approved for cervical cancer indications, and most of the cervical cancer indications of similar drugs are still in the clinical phase II stage
.
As the world's first innovative drug, this drug will bring Akeso a long period of exclusivity and huge profits
during the period.
In addition, Akeso said that it will continue to carry out the clinical phase III trial of ketanib in gastric cancer, liver cancer and non-small cell lung cancer to maximize the potential benefits of this product and lay the foundation
for the continuous growth of subsequent performance.
Another PD-1/LAG-3 biantibody of Akeso has been approved for clinical trial
on November 1.
Henlius also appears to be full of stamina
.
As of June this year, its serplulimab (Hans form) ® achieved sales revenue of about 76.
9 million yuan; The self-developed CD73 monoclonal antibody HLX23 was approved for clinical trial on November 7, and at present, there is no same-target drug on the market in the world, but there are many domestic companies including Innovent Biologics and Akeso, and the competition is fierce.
This year, Gilead's research on CD47 antibodies was suspended due to suspected unexpected serious side effects
.
However, the new player Yuheng Pharmaceutical's separimab (Yuto ®) was approved for marketing in August 2021, but it did not pass the preliminary formal review list in this year's medical insurance negotiations; Lepu Bioputelimab injection this year
It was approved for listing in July, but sales revenue has not yet been announced, and because it was approved for listing after June 30, 2022, it cannot participate in the negotiation
of the medical insurance catalogue in this negotiation.
Without a first-mover advantage or the incremental blessing of the medical insurance catalog, Yuheng Pharmaceutical and Lepu Biotech still need to make more efforts
in the commercialization layout.
In the stage when the domestic PD-1 market has become highly competitive, it is tantamount to a tiger to seize more market share in the hands of the "four tigers" that have achieved commercialization
.
Not to mention that these companies have already built iron walls and copper walls, opened up indications, and actively deployed overseas markets
.
The new players in PD-1 will have to put more effort into the commercialization war
.
