On February 7, 2024 TJ Biopharma (the "Company") reported that in order to give full play to the advantages of the Company’s R&D system and biopharmaceutical production and enhance the market competitiveness of the Company’s overall innovative drug pipeline, I-Mab Biotech (Hangzhou) Co., Ltd. (the "Company") reported that it has reached an agreement with Nasdaq-listed I-Mab to integrate and reorganize all of I-Mab’s Chinese business, team and pipeline with the Company’s existing pipeline and assets (Press release, TJ Bio, FEB 7, 2024, View Source [SID1234653999]). At the same time, the Company also announced the completion of a C1 round of financing of more than RMB 500 million. This round of financing was jointly invested by Tailong Investment, Zhejiang Province’s "4+1" Biopharmaceutical and High-end Equipment Industry Fund, I-Mab, Hangzhou Qiantang Chengfa Technology Service Co., Ltd., Bruggemoon Limited, and Ningbo Kaitou Hanrun Capital. Haoyue Capital served as the exclusive financial advisor for this transaction.

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After the reorganization is completed, the company will achieve a leapfrog improvement in the R&D system, talent team and commercial production of innovative biological drugs. The integrated innovative drug pipeline includes 10 clinical stage projects (including two products including Etan long-acting growth hormone, which will soon submit applications for listing in China), and 7 innovative drug projects in the preclinical or clinical application stage. The company’s first phase biological drug production base in Qiantang New District, Hangzhou has been put into operation, providing clinical research and recent commercial drug supply. Its 70-acre second phase commercial production base has also completed completion acceptance, which will greatly enhance the company’s ability to provide clinical and commercial drug supply for internal pipelines and domestic and foreign strategic partners.

Dr. Jingwu Zang, founder and chairman of the company, said : "I-Mab has grown rapidly from a start-up to a Nasdaq-listed company, and has continued to evolve and develop amidst the dramatic changes and challenges in the market environment over the past few years. With this strategic reorganization, we will set sail again with China as our foundation to reshape the company’s future and strategic development space. We will leverage our core R&D competitiveness accumulated over the years and our advantages in global project transactions to accelerate the internationalization of early-stage innovative drug projects and realize the phased value of the projects. At the same time, the company will focus on Phase III innovative drug projects to achieve local product commercialization cooperation and sustainable revenue. We will stay true to our original aspiration and aspire to build a leading company in the field of tumor immunotherapy and autoimmune disease treatment in China and even the world, bringing hope and cure to patients."

Mr. Jin Yufeng, Chairman of Heda Financial, the Executive Representative of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund, said : "The Tianjing team has first-class innovative drug research and development, production and global commercial transaction capabilities in the field of immunology, and has a technology platform of tumor-targeted bispecific antibodies with independent and complete intellectual property rights and first-of-its-kind antibody-small molecule inhibitor fusion drugs. It has laid out mature and differentiated clinical pipelines in multiple tumor and autoimmune treatment fields. The total scale of Zhejiang Province’s "4+1" Biopharmaceutical and High-end Device Industry Fund is 5 billion. After its establishment in October 2023, during the cold winter of pharmaceutical investment, it accelerated investment and support for the pharmaceutical industry against the trend. This participation in the reorganization of Tianjing Hangzhou is an important investment layout of the fund in 2023. We are very optimistic about the capabilities of the Tianjing team and hope that Tianjing Hangzhou will become the leader of innovative drug research and development companies in Hangzhou, help the construction of Qiantang China Pharmaceutical Port, and contribute to the biopharmaceutical industry in Zhejiang Province and even China."

Mr. Ding Yameng, Founding Managing Partner and COO of Haoyue Capital, said : "Haoyue Capital is honored to serve as the exclusive financial advisor for Hangzhou Tianjing’s C1 round of financing and assist the company in completing this transaction. Although the capital market is in a periodic adjustment, truly outstanding companies and entrepreneurs will actively seek change and bravely meet challenges. Congratulations to Hangzhou Tianjing for successfully completing its C1 round of financing. We are firmly optimistic that Hangzhou Tianjing will grow into a leading Chinese biopharmaceutical company integrating R&D, production and product cooperative sales in the future."

On February 7, 2024 Kyowa Hakko Kirin reported its Consolidated Financial Summary (IFRS) Fiscal 2023 (Press release, Kyowa Hakko Kirin, FEB 7, 2024, View Source [SID1234642359]).

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On March 7, 2024 AbbVie (NYSE: ABBV) reported that it will participate in the Barclays 26th Annual Global Healthcare Conference on Thursday, March 14, 2024. Robert A. Michael, president and chief operating officer, Scott T. Reents, executive vice president, chief financial officer, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, will present at 8:00 a.m. Central time (Press release, AbbVie, FEB 7, 2024, View Source [SID1234640941]).

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On February 7, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and that the U.S. Food and Drug Administration (FDA) placed all magrolimab studies in myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on full clinical hold (Press release, Gilead Sciences, FEB 7, 2024, View Source [SID1234640175]). These decisions follow the recommendation of an independent Data Monitoring Committee which reviewed top-line data from a planned interim analysis of ENHANCE-3 for overall survival (OS). In that analysis, magrolimab in combination with azacitidine plus venetoclax demonstrated futility and an increased risk of death was observed, primarily driven by infections and respiratory failure.

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Based on these results, as well as data from two other clinical studies in higher-risk MDS (ENHANCE) and AML with TP53 mutations (ENHANCE-2) where the primary analyses also demonstrated futility with an increased risk of death in the magrolimab-treatment arm, Gilead will not pursue further development of magrolimab in hematologic cancers.

Patients in the ENHANCE-3 study will discontinue treatment with magrolimab and Gilead is communicating with investigators to determine appropriate next steps for patients in the study. Sub-analyses of ENHANCE-3 for efficacy and safety are ongoing and results will be shared with regulatory authorities and will be submitted for presentation at an upcoming medical meeting and/or publication in a peer-reviewed journal.

Gilead will share a top-line, integrated summary of all pivotal magrolimab trials (ENHANCE, ENHANCE-2 and ENHANCE-3) shortly, as well as more detailed results of each trial in upcoming medical conferences. In addition, Gilead is reviewing the safety of magrolimab across all ongoing solid tumor trials and will provide an update on this assessment as soon as possible.

"The complexity of treating blood cancer is highlighted in these results," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are incredibly grateful to all the patients and investigators for their participation in the ENHANCE studies."

About ENHANCE-3
ENHANCE-3 is a Phase 3 study evaluating the safety and efficacy of magrolimab versus placebo in combination with venetoclax plus azacitidine in newly diagnosed, previously untreated patients with AML who are ineligible for intensive chemotherapy. More information about ENHANCE-3 (NCT05079230) can be found at ClinicalTrials.gov.

On February 7, 2024 QSAM Biosciences Inc. (OTCQB: QSAM) ("QSAM or the "Company") reported that it has signed a definitive Agreement and Plan of Merger (the "Agreement") providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) ("Telix") (Press release, QSAM Biosciences, FEB 7, 2024, View Source [SID1234639942]).

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Pursuant to the Agreement, QSAM stockholders will receive (i) $33.1 million in Telix ordinary shares ("Telix Shares") or cash, less an adjustment amount equal to QSAM’s indebtedness and payables as of the merger closing (the "Closing Consideration"), and (ii) contingent value rights ("CVRs") to receive future payments of up to $90 million upon the achievement of four clinical and commercial milestones within ten years of closing.

Prior to closing the merger, QSAM will effect a reverse stock split of its common stock in a ratio between 1:1000 and 1:2000. Each whole share of QSAM common stock outstanding after the reverse split will receive Telix Shares. Any remaining fractional shares of QSAM common stock resulting from the reverse split will be exchanged for an equivalent value in cash on a per share basis based on the per share price of Telix Shares as of the signing date of the Agreement. All QSAM stockholders will receive one CVR for each QSAM common share held prior to the reverse split.

Telix Shares issued to QSAM stockholders will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), but will be issued pursuant an exemption to the registration requirements thereunder, and more specifically, Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D; and as a result, will be subject to resale restrictions under Rule 144 of the Securities Act.

QSAM stockholders representing greater than a majority of the total voting stock of the Company have already approved the merger. Closing, however, is subject to various conditions set forth in the Agreement including, among others, the filing of a definitive information statement pursuant to Regulation 14C of the Securities Exchange Act of 1934, as amended (the "Information Statement"). The merger cannot be closed until 20 days after the mailing of the Information Statement to QSAM stockholders.

Dr. C. Richard Piazza, QSAM’s Executive Chairman and co-Founder, stated, "The signing of our Merger Agreement with Telix marks a major milestone for QSAM and our shareholders. We are thrilled to advance this transaction to signing and expect to complete the transaction in the first half of 2024, subject to the timing of our Information Statement and the satisfaction of customary closing conditions. We believe strongly that Telix is the right partner to advance Samarium-153-DOTMP through clinical trials and give this important technology the best chance to improve the lives of patients suffering from bone cancer. We are equally excited for our shareholders, as we believe this is a great outcome for their investments."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The acquisition of QSAM provides Telix with an additional near-term therapeutic pipeline asset, further differentiating our innovation position in radiopharmaceuticals and building depth in Telix’s key disease focus areas of urological and musculoskeletal oncology. Samarium is a highly optimal radionuclide for treating bone metastases, and the combination of Orphan Drug Designation and Rare Pediatric Disease Designation status with Telix’s demonstrated experience in pharmacy-based cold-kit distribution has strong potential for a rapid pathway to commercialisation of this asset."

Additional details about the Agreement, the CVRs and other material aspects of the merger and agreements and transactions contemplated by the merger will be provided in the Company’s Form 8-K to be filed subsequently with the SEC.