Focus: The annual reports of domestic pharmaceutical companies have been released one after another. How is the commercialization of blockbuster products?

2021 can be described as a bumper year for innovative drugs in China.
According to NMPA statistics, a total of 24 innovative drugs have been approved for marketing in China in 2021, hitting a new high in the past three years
.

Among them, there are a number of high-profile drugs, such as the first domestic ADC drug, Vidicitumumab, and two CAR-T products, Akilence Injection and Rekilenza Injection

List of blockbuster product sales

List of blockbuster product sales

Table: Sales Revenue of Listed Varieties in 2021

Data source: company annual report

01 Nuocheng Jianhua: Orbrutinib

01 Nuocheng Jianhua: Orbrutinib

Orelabrutinib is a selective Bruton tyrosine kinase inhibitor
.

In January 2021, the NMPA approved the marketing application for orelabrutinib for the treatment of r/r CLL/SLL and r/r MCL

In 2021, Orbrutinib will achieve sales revenue of 241 million yuan

Comments:

02Zai Lab: Ripatinib

02Zai Lab: Ripatinib

Ripatinib, an oral switch-regulated kinase inhibitor of KIT and PDGFRA kinases, has been approved in nine regions for the treatment of fourth-line advanced gastrointestinal stromal tumors (GIST)
.

Zai Lab obtained an exclusive license in 2019 to develop and commercialize ripatinib in Greater China

In 2021, Ripatinib will achieve revenue of $11.

Comments:

03 Corning Jerry: Envolumab (KN035)

03 Corning Jerry: Envolumab (KN035)

Envolizumab is a recombinant humanized PD-L1 single-domain antibody Fc fusion protein injection, the world's first subcutaneous PD-L1 inhibitor
.

On November 25, 2021, the State Food and Drug Administration officially approved the marketing of nvolimumab for adults with unresectable or metastatic microsatellite high instability/mismatch repair deficiency (MSI-H/dMMR).

As of December 31, 2021, the company has achieved sales revenue of 146 million yuan, of which envolimab has achieved sales revenue of 4.

Comments:

04 Rongchang Bio: Vidicitumab for Injection

04 Rongchang Bio: Vidicitumab for Injection

Vidicitumab for injection is an innovative antibody-drug conjugate (ADC) independently developed in China, which contains human epidermal growth factor receptor-2 (HER2) antibody part, linker and cytotoxic drug monomethyl auristatin E (MMAE), which provides a new treatment option for patients with locally advanced or metastatic gastric cancer
.

In 2021, Vidicitumab for injection will achieve sales of 84 million yuan , covering 374 hospitals and about 2,139 patients in 105 prefecture-level cities in 29 provincial administrative units across the country

In 2021, Vidicitumab for injection will achieve sales of 84 million yuan

Comments: The sales of 84 million yuan have been achieved within half a year of listing, and Vidicitumumab has achieved remarkable results
.

More benefits are waiting for this domestic ADC drug.

Comments:

05 WuXi Ju Nuo: Ruiki Orenza Injection

05 WuXi Ju Nuo: Ruiki Orenza Injection

Ruiki Orenza Injection is a CD19-targeting CAR-T cell therapy independently developed by WuXi Juno on the basis of JCAR017 from Juno in the United States.
It was approved for marketing on September 3, 2021 for the treatment of r/r LBCL in adult patients after second-line or more systemic therapy
.

As of December 31, 2021, Ruijilunsai injection has achieved a revenue of 30.
8 million yuan
.

As of December 31, 2021, Ruijilunsai injection has achieved a revenue of 30.
8 million yuan
.

As of February 2022, the company has established a team of 110 employees, covering sales team, marketing team, hospital access team,
etc.
In 2021, a total of 54 prescriptions for Ruiki Aurenzai Injection have been issued, and 30 patients have been reinfused
.
In addition, Ruiki Orenza injection has been included in 44 commercial insurance products and 16 municipal supplementary medical insurance plans
.

Comments: 2021 is the first year of CAR-T cell therapy in China, and CAR-T cell therapy is still in the process of exploration
.
After WuXi Junuo's Ruiki Orenza injection was launched, the company rapidly expanded its team, obtained 54 prescriptions within a few months, and included 44 commercial insurance products and 16 prefecture-level supplementary medical insurance plans.

.
However, the cost increase brought by commercialization is also obvious.
The company's annual report discloses that sales and marketing staff costs have increased by 70 million yuan, and business activity expenses have also increased by 47.
4 million yuan
.
The author believes that the development of CAR-T cell therapy in China is still "a long way to go"
.

Comments:

06 Fosun Kite: Achilles Injection

06 Fosun Kite: Achilles Injection

Achilles injection is an autologous immune cell injection prepared from autologous targeting human CD19 chimeric antigen receptor T cells (CAR-T) genetically modified with a retroviral vector carrying the CD19 CAR gene
.
Fosun Pharma has not disclosed the specific sales of akirenzai injection , but disclosed in its annual report that as of the end of February 2022, akirenzai injection has been listed in 23 provinces and cities in Huimin Insurance and more than 40 cities.
There are 75 registered treatment centers, and about 100 patients have entered the treatment process
.

Fosun Pharma has not disclosed the specific sales of akilenxe injection

Comments: Yescarta achieved global sales of US$695 million in 2021, a year-on-year increase of 23.
44%
.
At present, 4 CD19 CAR-T cell therapies have been approved for the market in the world, and the competition is becoming fierce.
Breyanzi, which will debut in 2021, has only achieved sales of 87 million US dollars, and has been left behind by the first-tier products
.

Comments:

07 Rongchang Bio: Taitahip

07 Rongchang Bio: Taitahip

Taitacept is a TACI-Fc fusion protein independently developed by Rongchang Bio.
It can inhibit two cytokines, BLyS and APRIL at the same time.
It has a new drug structure and dual-target mechanism of action.
Various autoimmune diseases such as rheumatoid arthritis
.
In 2021, Taitahip will achieve sales revenue of 47.
3 million yuan
.
In December 2021, Taitacept was included in the National Medical Insurance Directory
.

In 2021, Taitahip will achieve sales revenue of 47.
3 million yuan
.

Comments: As of December 31, 2021, the company has a total of 132 Taitahip sales teams, and the company has decided to continue to expand the sales team in 2022
.
In addition, the phase II clinical study of tetacept in primary Sjögren's syndrome (pSS) has achieved positive results, and the company also launched the phase III study of tetacept in the treatment of SLE in the United States in March 2022, and the drug will be sold overseas Just around the corner
.
Inclusion in health insurance is also expected to boost the volume of tacitabine
.

Comments:

summary

summary

Judging from the sales of listed drugs in 2021, Nuochengjianhua's orelabrutinib has won the top spot with sales of 241 million yuan, and the results can be described as dazzling
.
In recent years, the ADC and CAR-T drugs that have become popular in recent years have also achieved impressive results in the first year, but there is still a gap between them and small molecule drugs
.
Regarding the gap between drug R&D and commercialization mentioned at the beginning, the author believes that for innovative drug companies, on the one hand, they need to strengthen their commercialization capabilities , including medical insurance negotiation, pricing strategy, government affairs, hospital sales, etc.
We have also seen a number of Enterprises are actively including drugs in the national medical insurance list, and achieve sales growth by exchanging volume for price; on the other hand, through the overseas development of drugs to achieve leapfrog development , such as Nuochengjianhua to Bojian License out of Orbuti with US$940 million.
Nicholas has the exclusive global power in the field of multiple sclerosis, and successfully overtakes the corner
.

On the one hand, it is necessary to strengthen commercialization capabilities , and on the other hand, to achieve leapfrog development through drug delivery