GSK Exits BIO; First China-Originated Lung Cancer Targeted Drug Files for U.S. Approval; Jiangsu's Top TCM Company Enters GLP-1 Arena

A Total of 3 Briefs | Estimated Reading Time: 3 Minutes◆◆ ◆

01

Following Pfizer, Takeda, and Wuxi, GSK Announces Exit from BIO

Recently, according to FIERCE Pharma, following the successive exits of Takeda, Pfizer, UCB, WuXi AppTec and other companies, another MNC — GSK announced that it will withdraw from the Biotechnology Innovation Organization (BIO) in 2025.

GSK Chooses Not to Renew BIO Membership for 2025 After Annual Review of Corporate Memberships and Trade Association Involvement, Says Spokesperson in Email Statement

"The company representative added, 'We will continue to focus on fostering a policy environment that prioritizes disease prevention, addresses health equity and access barriers, and encourages sustainable innovation.' At present, we believe resources can also be concentrated in other areas."

Since December last year, several large pharmaceutical companies have announced their withdrawal from BIO.

Pfizer and UCB exited BIO in December 2023 and January 2024, respectively, while AbbVie severed ties with BIO in 2022.

On March 13, 2024, WuXi AppTec withdrew after BIO supported the U.S. House of Representatives' confirmation of the Biosecure Act, which specifically targets five Chinese life sciences companies, including WuXi AppTec and WuXi Biologics.

Following the Biden administration's signing of the Inflation Reduction Act (IRA) in August 2022, drug prices faced unprecedented challenges. BIO and PhRMA filed successive appeals, but even with substantial investments, they were unable to prevent government intervention in drug pricing.

This has also directly led to the withdrawal of major pharmaceutical companies.

(Source: PharmaResearch Network)

02

First Chinese-Origin Lung Cancer Targeted Drug Makes a Push for the U.S. Market

On November 8, Dizhen Medicine announced that the company's self-developed novel targeted lung cancer drug, Sunvozertinib (generic name: Sunvozertinib Tablets), has submitted a New Drug Application to the U.S. FDA for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy and whose tumors are confirmed to have epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) by an FDA-approved test kit.

Thus, Dizocilpine becomes the first China-originated lung cancer targeted drug to submit a new drug application to the U.S. FDA.

As the first source-innovated product in Zai Lab's pipeline, DZD9008 has already gained significant recognition before its attempt to enter the U.S. market: it is not only the world’s only approved and accessible small-molecule TKI targeting EGFR exon20ins NSCLC, but also the only drug in this field to have received Breakthrough Therapy Designation (BTD) from both China and the U.S.

At present, Dizhe Pharmaceuticals has taken the first step in entering the U.S. market, and the leading drug, Sunvozertinib, with its unique advantage as a global Best-in-Class (BIC) drug, undoubtedly holds promising prospects for a successful launch and commercialization in the U.S. market.

(Source: PharmaCube)

03

Jiangsu's Top TCM R&D Player Enters GLP-1

On November 7, Kangyuan Pharmaceutical announced that it plans to acquire 100% of Zhongxin Pharmaceutical for 2.7 billion yuan in self-owned funds. Both companies are controlled by Kangyuan Group, making this transaction a related party transaction, but not constituting a major asset restructuring. After the completion of the transaction, Zhongxin Pharmaceutical, a biopharmaceutical new drug research and development company, will become a wholly-owned subsidiary of Kangyuan Pharmaceutical, a long-established traditional Chinese medicine enterprise.

As early as 2015, Kangyuan Pharmaceutical set a development strategy focusing on the growth of traditional Chinese medicine while actively expanding into chemical drugs, biopharmaceuticals, and other fields to seek new growth paths. In the past five years, its cumulative R&D investment reached 2.768 billion yuan, with R&D spending accounting for over 10% of revenue annually—far surpassing the average of 3.3% among more than 70 listed traditional Chinese medicine companies. Currently, its pipeline is almost entirely concentrated on GLP-1.

According to the announcement, Zhongxin Pharmaceuticals has obtained six clinical approvals for four innovative drugs, all of which have entered the clinical stage.

Among the four major ongoing research projects, two are GLP-1 products: the long-acting GLP-1/GIP/GCG triple receptor agonist — (GGGF1) triple-target long-acting weight loss (hypoglycemic) fusion protein, and the long-acting GLP-1/GIP dual receptor agonist — (GGF7) dual-target long-acting hypoglycemic (weight loss) fusion protein.

Currently, no drug with the same structural type and the same target has been approved for marketing globally for the former, and it obtained clinical trial approvals for two new drugs for Type 2 diabetes, overweight, or obesity in November 2023. As for the latter, no drug with the same structural type has been approved for marketing globally, and it obtained clinical trial approvals for two new drugs for Type 2 diabetes, overweight, or obesity in December 2023. Phase I clinical research is currently underway.

In asset valuation, the two major GLP-1 pipelines account for nearly 70% of the weight. Particularly, the dual-target long-acting hypoglycemic (weight-loss) fusion protein holds a weight proportion as high as 48.17%, with the predicted drug market entry time being December 2027 based on the income approach. Additionally, the triple-target long-acting weight-loss (hypoglycemic) fusion protein has a weight of 17.86%, also expected to enter the market by the end of 2027.

(Source: E Pharm Exec)