Simcere Zaiming and AbbVie Strike $1.055B Deal for Early-Stage Trispecific Antibody SIM0500 in Multiple Myeloma

On January 13, ZAIMING, an innovative oncology drug company under Simcere, announced that it had entered into a development and licensing option agreement with global pharmaceutical company AbbVie for SIM0500, a multiple myeloma (MM) candidate drug currently in Phase I clinical trials in both China and the United States.

According to the terms of the agreement, ZAIMING will receive an upfront payment from AbbVie, as well as optional rights payments and milestone payments totaling up to $1.055 billion (approximately RMB 7.734 billion). ZAIMING will also receive additional tiered royalties based on the net sales of the product outside the Greater China region. AbbVie has the right to collect tiered royalties on net sales in the Greater China region.

Simcere was founded in 1995 by Ren Jinsheng. According to public information, Ren Jinsheng was born in July 1962. Due to his parents' work, he grew up in Nantong as a child and graduated from the Nanjing University of Chinese Medicine with a degree in Chinese pharmacy in 1982. He later obtained a master's degree and a master's degree in economics from Macquarie University in Australia. In 1992, at the age of 30, Ren Jinsheng quit his "iron rice bowl" job at a state-owned enterprise and started a business in Nanjing with six young people whose average age was only in their 20s. In 1995, at the age of 33, Ren Jinsheng became the general manager of Jiangsu Chengong Pharmaceutical Co., Ltd., which was established after restructuring—this company is the predecessor of Simcere.

In 2007, under the leadership of its core team, Simcere went public on the U.S. capital market, becoming the first biopharmaceutical and chemical pharmaceutical company from mainland China to be listed on NASDAQ. This also marked the largest IPO by an Asian pharmaceutical company that year. In 2014, after delisting from the U.S. stock market, Simcere underwent a comprehensive transformation, introducing重磅原研药 such as Endu. The company developed innovative drugs like Xianbi Xin, Envada, Cosela, Aidesin, and Xianuo Xin, while making significant achievements in building production bases, advancing research centers, and expanding international cooperation. In 2020, at the age of 58, Jinsheng Ren led Simcere through its second IPO, successfully listing on the Hong Kong Stock Exchange and reconnecting with the international capital market.

Over the past three decades, Ren Jinsheng has led Simcere through several successful transformations, continuously growing and expanding the company. His personal wealth, derived from Simcere's revenue, has made him a billionaire. In 2022, Ren Jinsheng and his family ranked 1818th on the Forbes Billionaires List with a fortune of $1.6 billion. In 2023, the Ren Jinsheng family was listed at 1346th on the Hurun Global Rich List with a wealth of 17 billion RMB.

In order to further focus on and accelerate innovation, Simcere has established ZAIMING.ZAIMING, a biopharmaceutical company under Simcere, is dedicated to the research, development, manufacturing, and commercialization of innovative oncology drugs. Established in December 2020, it began independent operations in 2023. Through restructuring, the independent ZAIMING has gained more decision-making power, enabling it to respond more effectively to market demands and create more down-to-earth products. Additionally, the incentives post-independence will be clearer, enhancing management's initiative and making the company more agile.

SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody developed by ZAIMING through its proprietary T-cell engager (TCE) multispecific antibody technology platform.This molecule combines a CD3 antibody with low affinity but high targeted activation, as well as two tumor-associated antibodies: anti-G protein-coupled receptor class C group 5 member D (GPRC5D) and anti-B cell maturation antigen (BCMA). SIM0500 exhibits potent T-cell cytotoxic effects against MM cells through multiple anti-tumor mechanisms.

In April 2024, the FDA granted SIM0500 Fast Track designation for patients with multiple myeloma who have previously received ≥3 lines of therapy (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies), and are resistant to all known standard treatments that can provide clinical benefit, or intolerant to them.

In fact, this is already the second major TCE deal that AbbVie has reached in the short term.

On October 31, 2024, AbbVie and EvolveImmune announced a collaboration and option licensing agreement to jointly develop multispecific biologics for the field of oncology. This discovery collaboration leverages EvolveImmune's TCE platform to develop novel antibody therapies targeting solid and hematologic malignancies. Under the terms of the agreement, EvolveImmune will receive a $65 million upfront payment and equity investment from AbbVie and is eligible to receive up to $1.4 billion in option fees and milestones, as well as tiered royalties on net sales.

Not only does AbbVie favor the TCE field, but other leading MNCs such as GSK, Sanofi, Gilead, and Merck have also closed TCE deals within the past year. Chinese pharmaceutical companies like Enmu Bio, Tongrun Bio, Genor Bio, EpimAb Bio, Conmana, and WuXi Biologics have recently achieved BD licensing in the TCE sector. TCE has undoubtedly become a focal point for both MNCs and Biotech firms, showing extraordinary vitality and popularity in major transactions, large-scale financing, mergers and acquisitions, or NewCo formations.

In terms of transactions,According to incomplete statistics from VCBeat, nearly 20 transactions occurred in this field in 2024, with a total amount exceeding 8.5 billion US dollars.

In terms of acquisitions,In January 2024, Merck announced the acquisition of Harpoon for $680 million at a price of $23 per share. Through this acquisition, Merck not only gained access to the promising DLL3/CD3 antibody currently in clinical trials but also obtained Harpoon's multiple tri-specific antibody platforms, including the next-generation multi-specific antibody platform—ProTriTAC and TriTAC-XR, which are specifically activated in the tumor microenvironment—enabling a rapid entry into the TCE field.

In terms of financing,Also in September 2024, Candid, an overseas innovative pharmaceutical company, announced the completion of a 370 million financing round, setting the record for the largest financing in the biopharmaceutical industry in 2024. Both of Candid's core products are TCE bispecific antibody varieties for autoimmune diseases purchased from a newly established overseas NewCo company of a Chinese pharmaceutical enterprise.

In the TCE field, NewCo's capital operation model is becoming increasingly popular.For example, in September 2024, EpimAb Biotherapeutics' BCMA×CD3 bispecific antibody EMB-06 went overseas through the NewCo model. A significant portion of the $60 million upfront payment in this deal will be paid in equity. It is understood that the transferee of this transaction, Vignette Bio, was incubated by Foresite Capital, with Qiming Venture Partners also participating in its financing.

Whether viewed from BD, M&A, or the NewCo model, the TCE track is showing a flourishing situation with multiple breakthroughs, indicating the vigorous development and future potential of this field. It can be foreseen that TCE bispecific antibodies will continue to lead the industry trend in the future, giving rise to more landmark blockbuster deals. This not only brings opportunities for pharmaceutical companies to make a comeback but also is expected to trigger a revolution of innovation and disruption in product development and market layout.

References:

1. "Over $3 Billion Raised in China! MNC Bets on TCE Therapy"

2. "Nantong's Mysterious Pharmaceutical Tycoon: Entered State-Owned Enterprise at 20, Founded Business at 30, Achieved Two IPOs in Six Years, Net Worth Exceeds 10 Billion..."