Top 10 Global New Drug Progress in 2023: Hengrui, China Biopharmaceutical, and Fosun Pharma Make the List

Throughout 2023, according to the Insight database, nearly 3,000 innovative drug projects in clinical stages have made progress globally.From the perspective of the highest parent company, there are 20 enterprises.Industry StatusNew ChangesDrug ProjectAll exceeded 15.

InventoryEachTotal number of corporate change projects and the number of projects at each stage,Hengrui PharmaWith over 50 new drug advancements successfully achievedSeize the top spot,In addition, Sino Biopharm, Fosun Pharmaceutical, CSPC Pharmaceutical Group Limited, Qilu Pharmaceutical, and Innovent Bio are all on the list.Among them,Sino BiopharmAndFosun PharmaceuticalAlso successfully enteredTop 10, with the remaining TOP10 spots occupied by MNCs such as AstraZeneca, Pfizer, Roche, and BMS.

Data Description:Source: DXY Insight DatabaseGlobal New Drug Module,Screening "Global Highest Progress" ≥ Applied Clinical, "Project Positive Status"Status" is not non-proactive, the global highest progress time frame is 2023.1.1-2023.12.31,The new drug type is a new drug (excluding improved new drugs and similar drugs, hereinafter the same) (data manually verified and organized; please correct if there are any errors).Early Clinical = Phase I + Phase I/II, Late Clinical = Phase II, Phase II/III, Phase III;

Below, Insight will briefly summarize the highlights of the top 10 Chinese companies that made it onto the list in 2023.

 Hengrui Pharma

Entering 2023, Hengrui Pharma's revenue and net profit have returned to a growth track.Revenue for the first three quarters has reachedRMB 17.014 billion, Q3 single quarterNet profit increased by 10.57% year-on-year.

In terms of R&D investment, Hengrui Pharma has never stopped growing. In the first three quarters of 2023, R&D expenses 3.73 billionYuan, a year-on-year increase of 6.5%。

In terms of the distribution of R&D progress, there is a stable and healthy structural distribution across clinical approval, early clinical, late clinical, and marketing stages, which facilitates a positive cycle—continuously bringing new drugs to the market, steadily advancing early-stage projects into clinical trials, and moving forward.

In the late-stage pipeline, Hengrui Pharma also achieved several milestone advancements in 2023. The DPP4 inhibitor Renglitinib and the PD-L1 inhibitor Adebrelimab were approved for marketing, while five other new drugs have successively filed for market approval, including Funaqizumab (IL17A monoclonal antibody), Imasitinib (JAK1 inhibitor), and Recarcimab (PCSK9 monoclonal antibody). These projects, which have been commercialized or are nearing commercialization this year, cover three of the most lucrative therapeutic areas: oncology, metabolism, and autoimmune diseases.

In terms of component categories, in addition to chemical drugs, ADCs, bispecific/multi-specific antibodies are also involved.PROTAC, etc. The popular ADC is undoubtedly also a key area currently being developed by Hengrui Pharma.

According to the Insight database, Hengrui Pharma ranks TOP1 among Chinese companies in terms of ADC projects that have entered the clinical stage, with 9 drugs in the past five years. These involve popular targets such as HER2 and TROP2, while also differentially targeting CD79B, HER3, and others.Among them, HER3 ADC SHR-A2009 at the 2023 ESMO CongressDebut，Second only to Daiichi Sankyo in becoming the 2nd to announce clinical results for the same-target ADC.

Hengrui Pharma: 9 ADCs Entered Clinical Stage in the Past 5 Years

Source: Insight Database Web Version (Unless otherwise specified, the following content is from the same source)

 Sino Biopharm

Sino Biopharm is also a leader among pharmaceutical companies in China. Not only did it receive approval for the collaboration with Eternity Bio on Pegsiticase in the first half of the year, but it also submitted three new drugs for marketing: the PI3Kα/δ inhibitor TQ-B3525, the PD-L1 inhibitor Bemarituzumab, andDeveloped in collaboration with Innovent BioKRAS G12C InhibitorGeshuruixi.

Moreover,ALK/MET/ROS1 Inhibitor Anakibatinib and ALK/MET/ROS Inhibitor Ifozatkib Reported in 2022There is also hope to achieve earlyApproved.

Sino Biopharm in the first half of this yearRevenue from innovative drugs reached 3.86 billion yuan, a year-on-year increase of 10.9%, accounting for 25.3% of the group's total revenue. Similar to Hengrui Pharma’s generic drug revenue starting to level off, Sino Biopharm also stated that all generic drugs with an annual revenue exceeding 500 million yuan (excluding exclusive products) have been included in centralized procurement.

Data from Sino Biopharm's semi-annual report, organized by Insight

Compared with Hengrui Pharma's wide-ranging layout across multiple fields, Sino Biopharm is highly focused on the oncology sector. Anlotinib is one of the key core products in this field, and TQB2450, or Bemarituzumab, is expected to become one of the important complementary products to Anlotinib after its approval, driving mutual growth through combination therapy.

This year, 20 new drug projects have made new clinical progress, three of which have newly entered Phase III clinical trials, includingTQB3454、TQB3823 andAL2846。It is expected that in the next three years, the swellingAbout 10 innovative drugs in the oncology field are expected to be approved for marketing.

 Fosun Pharmaceutical

Fosun Pharmaceutical has received approval for two innovative drugs this year, including Kaipulasheng jointly developed with KeyPharma and the long-acting erythropoietin product GX-E2 developed in collaboration with Genexine. Additionally, there is a CDK4/6 inhibitor.FCN-437c Report for listing.

Fosun Pharmaceutical Pipeline Layout Mainly InvolvesSwellingTumor, Immune, ChinaCentral Nervous Systemetc.Field, with a focus on strengthening small molecules,Antibody/ADC, Cell Therapy,Core technology platforms such as RNA. AndWith more positive progress in the later-stage pipelines, Fosun Pharmaceutical has long entered the harvest period.2022 Years of Fosun PharmaceuticalPharmaceutical business revenue exceeded 30 billion yuan for the first time, with innovative drugs and biosimilars sales surpassing 10 billion yuan.

At the same time, Fosun Pharmaceutical continues to increase its R&D investment. In 2022, the total R&D investment increased by 18.22% year-on-year, reaching 5.885 billion yuan. Of this, R&D expenses increased by 12.12% year-on-year to 4.302 billion yuan. The R&D investment in the pharmaceuticals business increased by 13.62% year-on-year to 5.097 billion yuan, accounting for 16.54% of the pharmaceuticals business revenue.

With the investment in R&D, more early-stage projects have entered the clinical phase. In 2023, the number of new drug projects entering clinical trials reached a historical peak, with a total of 19 projects.

Trend Chart of Fosun Pharmaceutical's Clinical New Drug Projects (Excluding Modified New/Biosimilar Drugs) in the Past 5 Years