On September 25, 2025 Jacobio Pharmaceuticals (1167.HK) reported that its Chairman and Chief Executive Officer, Dr. Yinxiang Wang, together with concerted parties, have recently increased their shareholding in the Company by 11.06 million shares, representing a total investment of approximately HK$96.34 million (Press release, Jacobio Pharmaceuticals, SEP 25, 2025, View Source [SID1234656247]). This action underscores their strong confidence in the Company’s long-term growth prospects.

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In addition, the Company’s share repurchase plan with an upper limit of HK$100 million, which was approved by the Board in July 2025, has already led to the repurchase of 326,400 shares, with a cumulative payment of HK$2.67 million. The Company will continue to implement the repurchase plan based on market conditions.

In the interim results for 2025 released earlier, Jacobio reported multiple encouraging R&D achievements. The Company continues to focus on two major R&D pillars – KRAS and iADC – with core programs making steady progress, further demonstrating Jacobio’s competitiveness and growth potential in the global biopharmaceutical sector.

Within the KRAS pathway, Jacobio has established a comprehensive development strategy. In May 2025, the Company’s KRAS G12C inhibitor, Glecirasib, was approved by the National Medical Products Administration (NMPA) for second-line monotherapy in KRAS G12C mutant non-small cell lung cancer (NSCLC) and successfully launched in China. This milestone not only marked Jacobio’s first commercial entry into the Chinese market but also triggered a milestone payment of RMB 50 million from its partner Allist. At the same time, Glecirasib is being evaluated in combination with the SHP2 inhibitor sitneprotafib for first-line NSCLC.

Beyond its marketed product, Jacobio’s pan-KRAS inhibitor JAB-23E73 has shown important progress. In the dose-escalation phase of its Phase I clinical trial, multiple confirmed partial responses (PRs) have been observed, with favorable safety and pharmacokinetic (PK) profiles consistent with expectations. Full Phase I data are expected to be released in the first half of 2026, which will mark a critical milestone for the global pan-KRAS landscape. Meanwhile, the Company is actively advancing next-generation KRAS inhibitors. The EGFR-KRAS G12D tADC project, which utilizes EGFR as the targeting antibody and KRAS G12D as the payload to enable precise and efficient treatment, is expected to submit an IND application in the second half of 2026.

In its other R&D pillar, iADC, Jacobio also maintains a leading position. The Company is developing JAB-BX467, a HER2-STING iADC candidate. By using a STING agonist as the payload, this innovative program is designed to convert "cold tumors" into "hot tumors," offering a novel treatment option for solid tumors where PD-1 monotherapy has limited efficacy. The program is currently at the preclinical stage, with IND submission planned for the second half of 2026.

As an innovation-driven biotechnology company, Jacobio is already positioned among the global leaders in KRAS and iADC research, with a clear development roadmap and significant commercial potential. The Company believes that its current share price does not fully reflect the value of its pipeline or its long-term growth potential. The decision by the Chairman and concerted parties to increase their shareholding by nearly HK$100 million not only demonstrates the strong alignment of interests between management and shareholders but also underscores their unwavering confidence in the Company’s long-term value creation.

On September 25, 2025 Biostar Pharma, Inc., the US wholly-owned subsidiary of Beijing Biostar Biopharmaceutical Co., Ltd. ("Biostar," stock code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that its core pipeline product Utidelone has once again been granted as Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of pancreatic cancer (Press release, Biostar, SEP 25, 2025, View Source [SID1234656246]). This marks the third ODD granted to Utidelone by the FDA, following prior designations for breast cancer brain metastases and gastric cancer.

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Pancreatic cancer is a highly malignant tumor known as the "king of cancers" due to its insidious early symptoms, difficulty in diagnosis, rapid progression, strong invasiveness, and poor prognosis. The five-year survival rate is only approximately 10%, far lower than that of other common cancers, making it the lowest among all malignant tumors. Currently, there is no clearly effective treatment for pancreatic cancer. Combination regimens based on gemcitabine remain the main clinical treatment, but due to the high tendency of pancreatic cancer cells to develop resistance to gemcitabine, treatment outcomes are often unsatisfactory.

The potential of Utidelone in treating pancreatic cancer has been well validated in both non-clinical and clinical studies. Preclinical data show that Utidelone can significantly inhibit the proliferation and colony-forming ability of pancreatic cancer cells and exhibits strong anti-tumor activity in pancreatic cancer models. When combined with gemcitabine, Utidelone markedly reduces the IC50 value of gemcitabine without compromising its anti-tumor effect, and the combination demonstrates stronger anti-tumor activity compared with the traditional paclitaxel plus gemcitabine regimen. At the 2024 CSCO Annual Meeting, Biostar presented preliminary results from a multicenter, single-arm Phase II clinical study evaluating Utidelone combined with gemcitabine as first-line treatment for unresectable advanced pancreatic cancer. As of the report date, 20 advanced pancreatic cancer patients which were unresectable and ineligible for local treatment had been enrolled, with 11 completing their first efficacy evaluation. Among them, 3 patients achieved partial response (PR), and 5 achieved stable disease (SD); the objective response rate (ORR) was 27.27%, while the disease control rate (DCR) reached 72.72%. The median overall survival (mOS) was 9.57 months.

About Orphan Drug

An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval.

About Utidelone

Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO (Free ASCO Whitepaper) annual meetings and published in prestigious journals.

On September 25, 2025 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported it will present the final clinical results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease (Press release, Leap Therapeutics, SEP 25, 2025, View Source [SID1234656244]). The final results will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17-21 in Berlin, Germany.

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Mini Oral Session Details:

Title: DeFianCe Trial: A randomized phase 2 trial of sirexatamab (DKN-01) plus bevacizumab and chemotherapy versus bevacizumab and chemotherapy as second-line therapy in advanced microsatellite stable (MSS) colorectal cancer (CRC)
Presenter: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of the GI Oncology Program at UCLA
Session Type: Mini Oral Session
Session Category: GI Tumours, Lower Digestive
Date and Time: Sunday, October 19, 2025, 4:05 p.m. CEST
Location: Cologne Auditorium – CityCube A
Abstract Number: LBA34

On September 25, 2025 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, reported the completion of the previously-announced plan of arrangement under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the "Purchaser"), an affiliate of Future Pak, LLC ("Future Pak"), pursuant to which the Purchaser has acquired all the issued and outstanding common shares of the Company (the "Shares") for US$3.01 per Share in cash plus one contingent value right ("CVR") per Share for additional aggregate cash payments of up to US$1.19 per CVR if certain milestones are achieved by the Company (the "Arrangement") (Press release, Theratechnologies, SEP 25, 2025, View Source [SID1234656243]).

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Consideration for the Shares has been remitted by the Purchaser to Computershare Investor Services Inc., as depositary under the Arrangement, and will be paid to former shareholders of Theratechnologies as soon as reasonably practicable after the date hereof (or, in the case of registered shareholders, as soon as reasonably practicable after a properly completed and signed letter of transmittal is received by the depositary together with the share certificate(s) and/or DRS Advice(s) representing Shares formerly held by them).

Each CVR is a contractual right that entitles the holder thereof to aggregate payments from the Purchaser of up to US$1.19 per CVR if certain milestones are achieved by the Company, the whole in accordance with the agreement entered into on the day hereof among the Purchaser, Future Pak and Computershare Trust Company of Canada as CVR agent. The CVRs are recorded in a register kept by the CVR agent and are not evidenced by a certificate or any other instrument. Based on a report prepared by an independent third-party valuator, the Company and the Purchaser have determined the fair market value of each CVR to be US$0.80 as at September 24, 2025.

As a result of the completion of the Arrangement, it is expected that the Shares will be de-listed from the Toronto Stock Exchange on or about September 26, 2025 and from the Nasdaq Capital Market on or about September 25, 2025. The Company shall apply to cease to be a reporting issuer under Canadian securities laws in all provinces of Canada. The Company will also deregister the Shares under the U.S. Securities Exchange Act of 1934, as amended.

Early Warning Reporting

Immediately prior to the effective date of the Arrangement, the Purchaser and its affiliates did not own any Shares. An early warning report will be filed on SEDAR+ at www.sedarplus.ca under the Company’s profile. Further information and/or a copy of the early warning report may be obtained from the contacts below. The Purchaser’s head office is located at CB Biotechnology, LLC c/o Honigman LLP, 2290 First National Building, 660 Woodward Avenue, Detroit, MI 48226-3506.

On September 25, 2025 Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with potential best-in-class therapeutic index, reported that it has entered into a licensing agreement with Qurient Co., Ltd., a clinical-stage biopharmaceutical company based in South Korea, for the development of a dual-payload ADC (Press release, Synaffix, SEP 25, 2025, View Source [SID1234656242]).

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Dual-payload ADCs are designed to deliver two separate cytotoxic agents with distinct mechanisms of action to target cancer cells, aiming to enhance therapeutic efficacy and mitigate payload resistance. Their therapeutic promise can potentially expand the current range of effective treatments while minimizing toxicity to healthy tissues, especially in refractory cancer cases.

The collaboration aims to develop a dual-payload ADC consisting of Synaffix’s exatecan-based technology and Qurient’s CDK7 inhibitor, aiming to target unmet medical needs in solid tumors. Under the terms of the agreement, Qurient will gain access to Lonza’s clinical-stage, site-specific ADC technology platform powered by Synaffix services including GlycoConnect antibody conjugation, HydraSpace polar spacer, and exatecan-based linker-payload technologies, as well as Lonza’s market-leading expertise and experience in developing and manufacturing bioconjugates.

Lonza will manufacture components related to its proprietary Synaffix technologies, and Qurient will perform the research, development, manufacturing and commercialization of the ADC, and manufacturing of Qurient’s CDK7 inhibitor.

Peter van de Sande, Head of Synaffix, said: "This licensing collaboration with Qurient signifies the versatility of our industry-leading ADC platform technology. Enabling the development of a dual- payload ADC built with Synaffix technology reflects our drive to continue pioneering innovation in the field."

Kiyean Nam, CEO at Qurient, said: "Dual-payload ADCs represent the next frontier in targeted antibody therapeutics, and we look forward to advancing this novel combination of our CDK7 inhibitor and Synaffix’s SYNtecan linker-payload. The combination of our proprietary technology with Synaffix’s industry-leading platform has the potential to be applicable to a wider range of targets and antibodies, and we look forward to exploring those possibilities in the future."