On July 15th, IMAB. US announced that its board of directors has appointed Fu Wei as the chairman of the board. Fu Wei will replace Pamela M. Klein, who will step down as director and interim chairman of Tianjing Biotechnology. And just a few months ago, Pamela M. Klein took over the position of interim chairman during the transition period, replacing former chairman and founder of Tianjing Biotechnology, Zang Jingwu.
According to official website information, Fu Wei has been serving as a director of Tianjing Biotechnology since June 2018. Fu Wei has been appointed as the CEO and Managing Director of Kangqiao Capital since April 2014. The company is a private equity firm focused on investing in the healthcare industry. Meanwhile, Kangqiao Capital is also the founding and largest shareholder of Tianjing Biotechnology.
It is worth noting that Tianjing Biology has undergone multiple high-level personnel changes since the beginning of this year. In February of this year, Tianjing Biotechnology announced the divestment of its assets in China and the reorganization of Tianjing (Hangzhou) Company domestically. Zang Jingwu immediately resigned from Tianjing Biotechnology and focused on the leadership work of Tianjing (Hangzhou) Company.
Insiders: The business situation is not optimistic since 2022, and the situation will be severe in 2023
It is reported that Tianjing Biotechnology is a global innovative biopharmaceutical company that is moving from the clinical stage to commercialization. It is committed to the research of target biology for innovative biopharmaceuticals, antibody processes, as well as clinical development and product commercialization in China and the United States.
In the capital market, Tianjing Biotechnology was listed on NASDAQ in mid January 2020, with an issue price of $14 and a fundraising amount of over $100 million. The company's "highlight moment" occurred in September 2020, when Tianjing Biotechnology successfully partnered with the well-known multinational pharmaceutical company AbbVie through its core pipeline - CD47 lemzoparlimab.
According to the terms of the agreement, AbbVie will make a down payment of $180 million to Tianjing Biotechnology to obtain authorization for Lenvatinib, and will also pay an additional $20 million as a milestone payment for the results of Phase 1 clinical trials, totaling $200 million. In addition, Tianjing Biotechnology will be eligible for milestone payments of up to $1.74 billion for the Lozomib project, with milestone payments of $840 million for clinical development and regulatory registration, and the remaining payments based on sales milestones.
The news released by Tianjing Biology on its official website. Tianjing Biotechnology Official Website
This transaction, with a potential total amount of nearly 3 billion US dollars, once set a new record for the amount of overseas authorization transactions by Chinese biopharmaceutical companies at that time. Afterwards, including Leflunomib and Fizettuzumab (a differentiated CD38 antibody for the treatment of multiple myeloma and systemic lupus erythematosus), Tianjing Biotechnology simultaneously promoted more than ten innovative drug development pipelines. At that time, the research and development progress seemed to be smooth sailing, which also helped the company's stock price reach a historical high of $85.4 per share at the end of June 2021, with a market value of nearly $7 billion.
However, it has been proven that the clinical research of lizumab has not progressed as expected. In August 2022, AbbVie decided to discontinue the global phase 1b clinical trial of the combination of lizumab, azacitidine, and venetoclax for the treatment of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). At the same time, Tianjing Biotechnology announced the revision of its CD47 antibody global strategic cooperation agreement with AbbVie. Although Tianjing Biotechnology stated that the two sides would continue to cooperate in the global development of anti-CD47 antibody therapy, the industry generally believes that the cooperation between the two has already shown cracks at this time.
In September 2023, Tianjing Biotechnology announced that AbbVie had terminated the agreement with the company to jointly develop and sell the CD47 antibody candidate drug, Lenvatinib, in 2020. The announcement also explains that AbbVie's comprehensive termination of the cooperation agreement is based on the termination of previous projects and AbbVie's strategic decision, and the termination agreement will take effect on November 20, 2023.
Success is AbbVie, defeat is AbbVie. As an innovative pharmaceutical company that has not yet commercialized its products, Tianjing Biotechnology heavily relies on external financing for its cash flow and the progress of its two core pipelines, Leflunomib and Ficetuximab. With the global pharmaceutical industry experiencing a cooling off in investment and financing, Tianjing Biotechnology is also deteriorating.
According to insiders close to Tianjing Biology, as Chinese concept stocks and innovative drugs reached their "last carnival" in the summer of 2021, capital has been declining all the way since then. Tianjing Biotechnology is still actively engaged in pipeline research and development in 2022, seeking refinancing from investors everywhere; But by 2023, with the entire industry facing a downturn in investment and financing, the vast majority of pharmaceutical companies will not be able to raise funds, and Tianjing Biotechnology will obviously have to rely on "grain storage" in their accounts to maintain operations. "Starting from 2022, the situation of (company operations) will not be optimistic, and by 2023, it will be very severe.
In February of this year, Tianjing Biotechnology announced significant strategic and personnel adjustments, stating that it had signed an agreement to divest its business and assets in China and focus on its US operations. Tianjing Biotechnology stated that as part of its transformation strategy towards a US biotechnology company, it has signed a final agreement with Tianjing Biotechnology (Hangzhou) Co., Ltd. (hereinafter referred to as "Tianjing Biotechnology (Hangzhou)") to divest the company's assets and business operations in China.
In addition, regarding the aforementioned changes in the company, Tianjing Biotechnology has stated to multiple media outlets that this is a strategic restructuring. In the future, listed company I-Mab will develop along the path of American biotech companies, while Tianjing Biotechnology (Hangzhou) will develop along the path of Chinese biotech companies, achieving maximum value for both parties without constraining each other; At the same time, the investor structure is more in line with their respective markets and better avoids investment risks in Chinese concept stocks, which is conducive to the valuation return of listed companies.
Why does CD47 target drag down Tianjing Biology?
As a "dream" target that can be widely expressed on different cancer cells and has the potential for pan cancer therapy, CD47 was once highly anticipated by the industry, and even considered to have the potential to replicate the success of PD-1. However, how did this dream target lead to the downfall of a star innovative drug company?
In fact, there are not only two pharmaceutical companies that have focused on CD47 targets, Tianjing Biotechnology and AbbVie. For example, Gilead, a pioneer in CD47 targets, has failed two core clinical trials of its CD47 monoclonal antibody Magrolimab; Another multinational pharmaceutical company, Roche, has also encountered obstacles in its exploration of CD47.
On February 7th of this year, Gilead announced the termination of its Phase III ENHANCE-3 study on the use of CD47 monoclonal antibody Magrolimab for the treatment of acute myeloid leukemia (AML). The FDA has placed all Magrolimab research on myelodysplastic syndrome (MDS) and AML (including related extended research projects) on full clinical hold. The reason is that IDMC has evaluated the latest data and found that Magrolimab+azacitidine+vencla has no therapeutic effect and increases the risk of death (mainly caused by infection and respiratory failure).
In terms of AbbVie/Tianjing Biotechnology, both parties have not disclosed the specific reasons for terminating the global phase 1b clinical trial of Lenzomib, but it is clear that it does not involve any safety issues. In addition, the industry generally believes that most CD47 targeted drugs under development cannot properly solve the problem of high affinity with red blood cells, resulting in a difficult balance between safety and efficacy.
Yiming Angke Chairman Tian Wenzhi once explained the reasons to the Daily Economic News reporter. He stated that CD47 is not only expressed on the surface of tumor cells, but also on the surface of blood cells, especially red blood cells, and the high affinity of antibodies leads to its inevitable binding with red blood cells. Even if some antibodies reduce their binding to red blood cells through design optimization, it is still difficult to avoid the "antigen silencing" effect caused by binding to other blood cells. In order for sufficient drugs to enter the tumor site and exert therapeutic effects, the dosage must be increased, thereby increasing safety risks.
You will find that both AbbVie/Tianjing Biotechnology and Gilead's CD47 antibody drugs have very high clinical dosages (such as Magrolimab's dosage of up to 30 milligrams per kilogram of body weight). Once the dosage is increased, the overall safety cannot be tolerated, which is a contradiction and a deadlock that cannot be resolved, "said Tian Wenzhi.
After announcing the divestment of its assets in China, the official website page of listed company Tianjing Biotechnology currently only has three innovative pipelines left, namely Uliledlimab (Uliledlimab, CD73 antibody), Givasomig (Claudin 18.2 x 4-1BB bispecific antibody), and Ragistomig (PD-L1 x 4-1BB bispecific antibody). Among these three products, the fastest progressing one, Yulelimumab, is in Phase II clinical trials. Tianjing Biotechnology announced that it will launch Phase III clinical trials of Yulelimumab combined with chemotherapy and immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) in the second half of 2024.
Situation of Tianjing Biological Pipeline. Tianjing Biotechnology Official Website
After Fu Wei takes over, it remains to be seen whether he can adjust his strategic layout and put Tianjing Biology, which has lost its CD47 target, back on track.