Inventory: 9 innovative drugs developed by Chinese companies have been declared for listing in the United States

The internationalization of Chinese pharmaceutical companies started with intermediates and APIs, and their capabilities and levels continued to improve.

Innovative drugs developed by Chinese companies and declared for listing in the United States

1.

Indications: Used in combination with other antiretroviral drugs for adult patients with multi-drug resistant HIV-1 infection that have failed existing treatment regimens

Ibalizumab was originally developed by Biogen.

In August 2017, the cGMP production base of WuXi Biologics for the production of lbalizumab's stock solution and sterile preparations successfully passed the pre-approval review of the U.

Ibalizumab is the first anti-HIV drug with a new mechanism of action in the past ten years, the first long-acting new HIV drug, the first monoclonal antibody to treat HIV, and the first biological drug manufactured by a Chinese company and approved by the FDA.

2.

Indications: Adult mantle cell lymphoma who has received at least one therapy in the past

Zebutinib is a BTK inhibitor independently developed by BeiGene.

In June 2020, Zebutinib was approved for marketing in China through priority review and special approval, for the treatment of adult mantle cell lymphoma (MCL) that has received at least one therapy in the past, and has received at least one therapy in the past.

In addition, Zebutinib was approved in the United Arab Emirates in February 2021 for the treatment of patients with relapsed or refractory MCL, and was approved for marketing in Canada in March 2021 for the treatment of Waldenstrom's macroglobulinemia (WM) Adult patients.

On February 17, 2021, BeiGene submitted the second sNDA application for Zebutinib to the FDA for the treatment of Waldenstrom's macroglobulinemia (WM).

3.

Indications: Hypertension

On December 20, 2019, CSPC announced that the FDA approved the marketing application of Conjupri (levamlodipine maleate) tablets for the treatment of hypertension.

CSPC held a pre-marketing application meeting with the US FDA in October 2018, completed key clinical studies in December 2018, and then completed the submission of the new drug application materials for the product in March 2019.

CSPC has promoted the sale of L-Amlodipine Maleate Tablets (trade name: Xuan Ning) in China since 2003.
The clinical development of L-Amlodipine Maleate Tablets in the United States is based on China's safety and efficacy data, as well as data showing that L-Amlodipine has fewer adverse effects than amlodipine.

4.
Risperidone Microspheres for Injection II

Company: Luye Pharmaceutical

Indications: Schizophrenia

Risperidone Microspheres II for Injection (trade name: Recinto) is a sustained-release preparation of risperidone developed by Luye Pharma based on its microsphere technology platform.
It is an improved new drug and is administered by intramuscular injection every two weeks.
once.
Compared with products already on the market, Recinto does not need to take oral preparations 3 weeks after the first injection, and can reach steady-state blood drug concentration faster, providing patients with new treatment options.
Rexinto is the first domestic innovative microsphere preparation with independent intellectual property rights and global registration, and it is also the first domestically developed second-generation long-acting antipsychotic injection.

Luye Pharmaceuticals submitted a marketing application to the U.
S.
FDA in May 2019.
During this period, Luye received a complete response letter (CRL) from the FDA regarding the product.
In the letter, the FDA requested Luye to provide more information and solve the inspection problem of the raw material drug production site.
, The US approval of Risperidone Microspheres II for injection will be delayed.

Risperidone Microspheres II for injection has passed the priority review and approval method and was approved by the National Food and Drug Administration on January 14 this year.
Its patents have been authorized in China (including mainland China and Hong Kong), the United States, Europe, Japan, South Korea, Russia, Canada, and Australia, and the patent period is up to 2032.

5.
Cidacchi Oron (cilta-cel)

Company: Legendary Bio

Indications: Treatment of relapsed and/or refractory multiple myeloma (MM) in adults

cilta-cel is a CAR-T therapy targeting B cell maturation antigen (BCMA) independently developed by Legend Bio, and it is also the first variety to be included in CDE as a breakthrough therapy.
In December 2017, Yang Sen (a Johnson & Johnson company) and Nanjing Legend (a subsidiary of KingScript Biotechnology) reached a license agreement.
Nanjing Legend granted Yang Sen the right to jointly develop and promote cilta-cel globally.

On December 21st, Janssen/Legendary Bio announced that it has begun rolling submission of cilta-cel's Biologics License Application (BLA) to the FDA for the treatment of relapsed and/or refractory multiple myeloma in adults.
The application materials have been submitted recently.

cilta-cel is expected to become the first cell therapy approved by a Chinese company in the United States, and it is also expected to become the world's second BCMA CAR-T cell immunotherapy approved for marketing after Bristol-Myers Squibb Abecma.

6.
Surufatinib

Company: Hutchison Pharmaceutical

Indications: Pancreatic and non-pancreatic neuroendocrine tumors

Sofatinib is a new oral tyrosine kinase inhibitor independently developed by Hutchison Medicine.
Based on two phase III neuroendocrine tumor clinical studies in China and data support in the treatment of patients with non-pancreatic and pancreatic neuroendocrine tumors in the United States, Hutchison Medicine submitted a rolling submission of Sofantinib for the treatment of pancreas to the U.
S.
FDA on December 28, 2020 A new drug application for non-pancreatic neuroendocrine tumors (NETs), this is Hutchison’s first US NDA.
If approved, Sofatinib will be the first local innovative drug to be simultaneously marketed globally using Chinese clinical research data, or it will create a record for the approval of Chinese drugs in the European and American markets.

Sofatinib was approved for listing in China on December 30 last year under the trade name Sutaida.
For the treatment of non-pancreatic neuroendocrine tumors (NET), it is the only VEGFR-TKI drug approved for the treatment of non-pancreatic NET in the world.
The marketing application of Sofatinib for the treatment of pancreatic NET indications is under review by the State Food and Drug Administration.

7.
Teriprolizumab

Company: Junshi Bio

Indications: recurrent or metastatic nasopharyngeal carcinoma

On March 3, Junshi Biotech announced that it had begun rolling submission of teriprizumab to the US FDA for the treatment of BLA for recurrent or metastatic nasopharyngeal carcinoma.
Since this indication was approved as a breakthrough therapy by the FDA in September last year, it can be submitted to the FDA on a rolling basis and obtained rolling review.
Teriplizumab is the first domestic anti-PD-1 monoclonal antibody to submit BLA to the FDA.

Teriplizumab is also China’s first anti-PD-1 domestic monoclonal antibody drug approved for marketing.
Since its first approval for marketing in December 2018, two indications have been conditionally approved for marketing by NMPA.
Unresectable or metastatic melanoma that has previously failed systemic treatment and recurrent/metastatic nasopharyngeal carcinoma that has failed second-line or above systemic treatment.
In addition, the indications for the treatment of locally advanced or metastatic urothelial cancer that have been treated in the past will soon be approved; the first-line treatment of nasopharyngeal carcinoma indications are in the approval stage.
According to the financial report, the sales of Teriplimumab in 2020 will be 1.
003 billion yuan.

8.
Recombinant human granulocyte colony stimulating factor-Fc fusion protein (Ryzneuta™, F-627)

Company: Yiyi Bio

Indications: Prevention and treatment of neutropenia caused by cancer patients during chemotherapy

F-627 is an innovative biopharmaceutical developed by Yiyi Biologics (formerly known as Jiannenglong), a subsidiary of Efan Pharmaceuticals, based on the proprietary and independent intellectual property rights Di-Kine bimolecular technology platform.
The type of drug belongs to the Fc fusion protein and is expressed by CHO cells.
Recombinant human granulocyte colony stimulating factor (rhG-CSF) dimer, with long-acting and potent biological characteristics, is used to prevent and treat neutropenia caused by cancer patients during chemotherapy.

On March 31 this year, Yiyi Biotech submitted a BLA application for F-627 to the US FDA.
EiBio is the first biopharmaceutical company to complete Phase I, Phase II and Phase III clinical trials at home and abroad and declare BLA to the US FDA.

9.
Punabulin

Company: Wanchun Pharmaceutical

Indications: In combination with G-CSF, it is suitable for severe neutropenia (CIN) caused by myelosuppressive anticancer drugs in patients with non-myeloid malignant tumors

Pranabrin is a First-In-Class new drug independently researched and developed by Wanchun Pharmaceutical.
It is a new small molecule drug optimized with natural seaweed active ingredients.
The breakthrough features of Pranabrin include: ①75% of clinical adverse events occurred during the first 8 days, and the current standard therapy G-CSF cannot take effect in the first 8 days.
Pranabrin can quickly take effect in the first 8 days to protect neutrophils; ② When combined with G-CSF, it forms a complement, significantly reducing the incidence of severe CIN in patients with non-medullary cancer due to chemotherapy.

In the second half of 2020, the National Food and Drug Administration of China and the U.
S.
FDA respectively granted pranablin breakthrough therapy designation for the treatment of CIN.
On March 31, Wanchun Pharmaceutical submitted a marketing application to NMPA and FDA at the same time, becoming the first product of Wanchun Pharmaceutical to declare for marketing.

In addition to the above nine innovative drugs, HLX02 (trastuzumab) developed by Henlius was approved by EMA in July 2020; Biotech also announced that it had submitted BAT1706 to EMA and the US FDA at the end of November last year.
(Bevacizumab) application for marketing of biological products.
This is the first time Biotech has submitted a marketing authorization application outside of China, and it is also the first domestic bevacizumab biosimilar to be marketed in the United States.