55 Class 1 New Drugs Dominate Pipeline! Long-Acting Neutropenia Drug Targets RMB 5 Billion Market

Following the submission of its imported long-acting white blood cell booster for production, CHIATAI TIANQING has partnered with XtalPi to co-develop small molecule new drugs targeting challenging sites, accelerating and enhancing innovative R&D. Currently, CHIATAI TIANQING has 70 new drugs (55 of which are Class 1 new drugs) in the clinical application stage or higher, with four under review for market approval, six in Phase III clinical trials, marking a period of concentrated harvest for its innovative pipeline. Leveraging generics to drive innovation, it has achieved positive evaluations for 52 products, won bids for 19 products in bulk procurement, and is preparing eight products for the seventh round of centralized procurement.

 

 

On March 18, Sino Biopharm announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Chia Tai Tianqing"), has reached a strategic cooperation with XtalPi Holdings Limited. Both parties will jointly develop small molecule new drugs targeting difficult targets for the treatment of malignant tumors. This collaboration will help Chia Tai Tianqing strengthen original innovation and enhance differentiation, leading to the development of high-quality cancer treatment drugs.

 

As a leading enterprise in liver disease drugs in China, CHIATAI TIANQING has expanded from a "combination of generic and innovative drugs" to a "combination of innovative and generic drugs" in recent years. It continuously strengthens its drug innovation with independent intellectual property rights, ensuring its position in the field of liver diseases while further enhancing its competitiveness in the anti-tumor field, and increasing investment in the biopharmaceuticals sector.

 

Currently, CHIATAI TIANQING has 55 Class 1 new drugs in the clinical application stage or above (excluding marketed drugs applying for new indications), covering liver diseases, oncology, respiratory conditions, infections, and more.DiseaseFields. Among them, there are 44 small-molecule chemical drugs and 11 large-molecule biologics.

 

　CHIATAI TIANQING's Class 1 New Drug Under Research

Source: MiNei Network Database, Company Announcements

 

Among the 55 Class 1 new drugs, the marketing application for Eibegseptin α Injection has been submitted. Three new drugs, including TQB2450 Injection (PD-L1 monoclonal antibody), TQ-B3139 Capsules (ALK inhibitor), and TQB3616 Capsules (CDK4/6 inhibitor), have entered Phase III clinical trials. Additionally, eight Class 1 new drugs are in Phase II clinical trials, including TQ-B3525 Tablets (PI3K inhibitor), TQ-F3083 Capsules (DPP-4 inhibitor), and TQ05105 Tablets (JAK2 inhibitor).

 

It is foreseeable that CHIATAI TIANQING's innovative pipeline will enter a period of intensive harvest.

 

Previously, CHIATAI TIANQING has commercialized three Class 1 new drugs, including Magnesium Isoglycyrrhizinate Injection (Tianqing Ganmei), Anlotinib Hydrochloride Capsules (Fukewei), and Penpulimab Injection (Annikang). Among them, Tianqing Ganmei and Fukewei have long become blockbuster products with sales of over 1 billion yuan, and Penpulimab is expected to reach the 1 billion yuan target soon.

 

Efgartigimod Alfa Injection is expected to become CHIATAI TIANQING's fourth Class 1 new drug to be marketed. On February 25 this year, the marketing application for Yiya Bio's long-acting white blood cell booster Efgartigimod Alfa Injection was accepted by the CDE for neutropenia. On August 29, 2021, Yi FanPharmaceuticalsYi Fang Biologics, a subsidiary of Sino Biopharm, and Shunxin Pharmaceutical, a subsidiary of CHIATAI TIANQING, have reached an exclusive commercialization and licensing agreement for Efbegecept Alfa, with a total transaction value exceeding 210 million yuan.

 

Currently, four domestically produced long-acting white blood cell boosters have been approved for production in the Chinese market, involving companies such as Qilu Pharmaceutical, CSPC Pharmaceutical Group, Hengrui Medicine, and Shandong New Era. Data from Menet shows that in recent years, the market size of domestically produced long-acting white blood cell boosters in China has continued to rise, with significant growth observed in urban public hospitals in 2020.HospitalThe terminal sales revenue of county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) exceeded 5 billion yuan, with a year-on-year increase of 49.07%.

 

 

On January 18 this year, CHIATAI TIANQING's first biosimilar – Adalimumab Injection – was approved for marketing, making it the fifth biosimilar produced in China. According to AbbVie’s financial report, Humira’s global revenue in 2021 was $20.694 billion. Driven by medical insurance and biosimilars, the market for Adalimumab in China has seen rapid growth, with sales in Chinese public medical institutions nearing 1 billion yuan in 2020.

 

In addition to the Class 1 new drug, CHIATAI TIANQING has 15 new drugs under development, including biosimilars, improved chemical drugs, and other biologics. Among them, four biologics—Recombinant Human Coagulation Factor VIII for Injection, Bevacizumab Injection, Trastuzumab for Injection, and Rituximab Injection—have already been submitted for marketing approval.

 

　Other new drugs under development by CHIATAI TIANQING

Source: MiNei Database, Company Announcements

 

Recombinant Human Coagulation Factor VIII for Injection is an anti-hemophilia factor used for the control and prevention of bleeding in adolescent and adult patients with Hemophilia A (congenital Factor VIII deficiency). Data from MiNe Network shows that sales of Recombinant Human Coagulation Factor VIII for Injection in Chinese public medical institutions exceeded 1.4 billion yuan in 2020, representing a year-on-year increase of 24%. Currently, the only domestically produced product approved is from Sino Biological, while CHIATAI TIANQING is striving to become the second Chinese manufacturer.

 

In addition to the already marketed Adalimumab biosimilar, CHIATAI TIANQING has also laid out plans for six other monoclonal antibody biosimilars. Among them, Bevacizumab, Trastuzumab, and Rituximab, which have been submitted for marketing approval, are expected to be approved for market launch within the next year or two. Moreover, Pertuzumab is currently in Phase III clinical trials, Ramucirumab has completed Phase I clinical trials, and Mepolizumab injection has been approved for clinical trials.

 

According to Roche's financial report, the global revenue of Avastin (Bevacizumab), Herceptin (Trastuzumab), and Rituxan (Rituximab) in 2021 totaled 8.315 billion Swiss francs (9.1 billion US dollars, based on the average exchange rate in 2021). Data from MiNe Network shows that the combined sales of Bevacizumab, Trastuzumab, and Rituximab in China's public medical institutions in 2020 exceeded 14 billion yuan.

 

It is worth noting that, in China, only the rituximab biosimilars from Henlius and Innovent Biologics have been approved for marketing. CHIATAI TIANQING's product is the third to submit a marketing application and is expected to become the third domestically produced rituximab biosimilar. For trastuzumab biosimilars, only Henlius has received approval so far, while Anke Bio, Hisun Bio, and CHIATAI TIANQING are competing to become the second domestically produced option.

 

 

As of now, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has had 52 varieties (73 specifications) pass/be considered to have passed the consistency evaluation. Among them, 20 varieties are the first in China to pass the evaluation, and Imatinib Mesylate Capsules, Pomalidomide Capsules, and Ganirelix Acetate Injection are exclusively passed.

 

52 varieties passed the review, mainly concentrated in anti-TumorAnd immunomodulators (18), systemic anti-infective drugs (10), digestive system and metabolic drugs (10).

 

　　CHIATAI TIANQING Pharmaceutical Group Co., Ltd. Products that have passed/been deemed to pass the consistency evaluation

Note: Marked with * as the first to pass the review.

 

In the first five rounds of centralized procurement conducted in China, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. won bids for 3, 1, 3, 5, and 7 products respectively, totaling 19 products. In the upcoming seventh round of centralized procurement, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. has already secured spots for 8 products.

 

CHIATAI TIANQING's Competitive Landscape for the Seventh Batch of Proposed Centralized Procurement Varieties

Note: Sales below 100 million yuan are represented by *

 

Among the eight proposed centralized procurement varieties, competition for Tenofovir Alafenamide oral conventional release formulations and Palonosetron injectionsEnterpriseWith more than 10 competitors, the competitive landscape for varieties such as Lurasidone Hydrochloride Tablets and Sunitinib is favorable; CHIATAI TIANQING's five varieties, including Afatinib Oral Immediate-Release Formulation, Tenofovir Alafenamide Oral Immediate-Release Formulation, Lenvatinib Mesylate Capsules, Sunitinib Oral Immediate-Release Formulation, and Lurasidone Hydrochloride Tablets, are markets yet to be developed. Winning a centralized procurement bid will rapidly open up the market.

 

　Data source: MiNei database, company announcements

 

Note: Data statistics are as of March 22. If there are any omissions, corrections are welcome!