China Resources Pharma to Divest 17.87% Stake in Tianmai Biotech for RMB 1.42 Billion Following Oral Insulin Setback

On February 9, CR PHARMA COMM announced that its wholly-owned subsidiary, CR Pharma Investment, has initiated the potential sale of approximately 17.87% equity interest in HTBT held by CR Pharma Investment and its subsidiaries. The equity interest will be publicly listed for transfer through the Shanghai United Assets and Equity Exchange, with a minimum listing price of approximately RMB 1.42 billion.

Data from Tianyancha shows that HTBT has a relatively diversified equity structure, involving 21 shareholders. Among them, CR PHARMA COMM directly holds a 20% equity stake in HTBT, with a paid-in capital of RMB 160 million, making it the largest and core shareholder of the latter. Upon completion of this transaction, CR PHARMA COMM’s shareholding ratio will decrease to approximately 2.13%, marking its formal exit from the ranks of HTBT’s core shareholders.

HTBT was established in 2010. Since its inception, HTBT has been dedicated to the introduction and development of a series of products and technologies for diabetes, as well as providing whole-course disease management services for patients with diabetes.

In terms of R&D, HTBT has signed a "Framework Agreement for Joint Research and Development of Biopharmaceutical Technologies and Products" with its partner, Vaniery Pte. Ltd. of Singapore. Based on Vaniery’s joint laboratory in Yavne, Israel, and the R&D center of Hefei Tianmai, the two parties have established joint development bases for biopharmaceutical technologies and products in Yavne, Israel, and Hefei, China.Since 2010, leveraging the joint laboratory established in Yavne, Israel, HTBT has successfully developed active pharmaceutical ingredients (APIs) and formulated products of human insulin and insulin analogs.In addition, the company has further expanded its business to offer CDMO services, including the research, development, and delivery of recombinant proteins, as well as the development and commercial manufacturing and delivery of sterile biologics.

In 2015, HTBT acquired the rights to the oral insulin project ORMD-0801 in China for a total transaction value of $50 million.ORMD-0801 is a recombinant human insulin enteric-coated capsule developed by Oramed Pharmaceuticals of Israel. In terms of its technological approach, ORMD-0801 consists of an enteric coating, protease inhibitors, absorption enhancers, and insulin. The core value of this technology lies in its multi-layered composite capsule design: the outermost layer features an enteric coating that enables the capsule to withstand the acidic environment of the stomach, protecting its contents until they reach the small intestine; the inner layer contains insulin, protease inhibitors, and absorption promoters, which reduce insulin degradation in the intestinal tract and facilitate its transmembrane absorption.

The design goal of ORMD-0801 is to enable insulin to effectively enter the systemic circulation via an oral delivery system, thereby providing a treatment option for patients with type 2 diabetes who have inadequate response to oral hypoglycemic agents, in an effort to overcome the long-standing challenge that “insulin cannot be administered orally.”

Perhaps it was precisely the vast diabetes market that HTBT focused on, along with the potential breakthroughs its oral insulin could bring, that led CR PHARMA COMM to sign a strategic cooperation agreement with HTBT and complete its investment in 2016.However, the specific amount of this investment was not explicitly disclosed in public records. According to subsequent public information, CR PHARMA COMM became a significant shareholder of HTBT through this investment, with its shareholding ratio reaching 20% at one point.

However, at the end of 2017, CR PHARMA COMM sold its 14.12% equity stake in HTBT for a fair value of approximately HK$1.147 billion. This transaction was based on relevant clauses in the share subscription agreement signed between CR PHARMA COMM and HTBT’s major shareholders, as HTBT had not obtained its GMP certificate by December 31, 2017, thereby triggering the conditions for equity divestment. The equity interest was subsequently transferred through a public listing process via a property rights exchange. Nevertheless, in 2020, CR PHARMA COMM disclosed in a publication that it still held a 23.75% stake in HTBT, suggesting that it had increased its shareholding after the 2017 divestment.

During the periods of separation and reunion between CR PHARMA COMM and HTBT, specifically in June 2018, Yuheng Pharmaceutical announced that it would acquire no less than 35% of the transferable, unencumbered equity interest in HTBT at a price of no less than RMB 4 billion. Based on this calculation, HTBT’s valuation in 2018 was at least RMB 11.4 billion. However, CR PHARMA COMM’s recent sale of approximately 17.87% equity interest in HTBT for RMB 1.42 billion implies a current valuation of approximately RMB 7.95 billion for HTBT, representing a decline of about 30% compared to the valuation during Yuheng Pharmaceutical’s proposed acquisition in 2018.

Upon completion of this transaction, CR PHARMA COMM’s shareholding will decrease to approximately 2.13%, marking its formal exit from the core shareholder ranks of HTBT after a decade-long partnership.

One of the key reasons why CR PHARMA COMM viewed HTBT favorably a decade ago was HTBT’s introduction of the oral insulin ORMD-0801. However, it was also ORMD-0801 that led to the “breakup” between the two parties.

In January 2023, the originator company Oramed announced overseas that its Phase III clinical trial for type 2 diabetes (the ORA-D-013-1 study) failed to meet its primary endpoint (change in glycated hemoglobin) and secondary endpoint (change in fasting blood glucose). The study enrolled 710 patients, and the results showed that, compared with placebo, ORMD-0801 did not significantly improve glycemic control. Additionally, issues such as an unclear dose-response relationship were observed (e.g., the glucose-lowering effect in the high-dose group was not superior to that in the low-dose group).

Just three months after the failure of its Phase III trial abroad, in April 2023, HTBT announced that it had completed its Phase III clinical trial in China and submitted a marketing application for ORMD-0801 to the National Medical Products Administration, becoming the first oral insulin to seek market approval globally.In response, HTBT stated that differences in the enrolled populations (milder disease severity, different BMI ranges), sample sizes (522 participants in China vs. 710 overseas), and dosing regimens (16 mg three times daily in China vs. 8 mg once or twice daily overseas) between the domestic and foreign trials may have led to disparate study outcomes.

However, the National Medical Products Administration (NMPA) conducted a comprehensive assessment based on existing clinical data, technical feasibility, and safety,On December 29, 2025, a regulatory notice regarding ORMD-0801 was issued, signaling that the drug failed to gain marketing approval. The failure of this oral insulin project has forced HTBT to retreat to the traditional injectable insulin market. However, in the fiercely competitive landscape shaped by centralized volume-based procurement, HTBT lacks economies of scale and falls behind industry leaders such as Gan & Lee Pharmaceuticals and Tonghua Dongbao, particularly due to its insufficient technological reserves in third-generation insulin analogs. The setback in its core pipeline, coupled with a lack of reserve candidates, prompted CR PHARMA COMM to divest this non-core asset.

For HTBT,In the short term, CR PHARMA COMM’s exit may impact market confidence and HTBT’s financing capabilities, necessitating a strategic and financial restructuring. However, by maintaining a long-term focus on its traditional insulin business, enhancing production efficiency and market competitiveness, or exploring new technological directions, HTBT still has the opportunity to identify new growth pathways in the field of diabetes treatment.

For CR PHARMA COMM,HTBT is not an isolated case. In the past two years, entities under the “China Resources (CR) system” have frequently divested non-core assets: CR Sanjiu transferred its equity stake in Anguo Traditional Chinese Medicine, CR Sanjiu sold its shares in Jointown Pharmaceutical Technology, and CR Boya Bio-pharmaceutical Group repeatedly lowered prices to offload an 80% stake in Boya Xinhe... Although the companies involved and the businesses divested differ, the underlying objective remains consistent—these divestitures of non-core assets are not passive attempts to “shed burdens,” but rather proactive strategic moves driven by a combination of policy, industry, and strategic factors.

In summary, CR PHARMA COMM’s divestiture of HTBT is a comprehensive decision driven by strategic, financial, and industry-environment factors, reflecting the company’s ability to adjust its strategy and manage risks in a complex market environment. This decision not only demonstrates a realistic assessment of HTBT’s current challenges but also provides new directions and opportunities for the future development of both parties.

Reference Article: "Why Did the Marketing Application for Oral Insulin Fail?"