On November 21, 2025 BioDlink (Stock Code: 1875.HK), a leading biologics CDMO, together with Lepu Biopharma (2157.HK), reported the successful market launch of MEIYOUHENG(Becotatug Vedotin injection) , the world’s first EGFR-targeting antibody-drug conjugate (ADC). The launch also represents the first ADC fully manufactured by a CDMO to reach the market in China, underscoring a new level of maturity for the region’s biopharmaceutical ecosystem.

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Senior leadership and project teams from both companies gathered at BioDlink’s Suzhou headquarters to commemorate this achievement—a milestone that reflects deep scientific collaboration, disciplined execution, and shared commitment to advancing complex biologics.

A Fully Integrated CDMO Success Story

The approval and launch of MEIYOUHENG validate BioDlink’s end-to-end CDMO capability, spanning: technology transfer, pivotal clinical production , PPQ batches, pre-Approval Inspection (PAI) preparation, comprehensive BLA support through granted marketing approval by China’s National Medical Products Administration (NMPA) on October 30, 2025. The tech transfer was achieved in less than 3 months, and the PPQ was completed in less than 11 months, with minimal deviations.

Operational Excellence That Sets a New Benchmark

All technology transfers and GMP production batches were successfully completed at the first go, highlighting BioDlink’s strength in quality systems, regulatory alignment, and manufacturing reliability. The collaboration demonstrates how high-performing CDMOs can serve as strategic partners—not just service providers—across the entire lifecycle of cutting-edge therapies.

Dr. Jian Zhang, Chief Operating Officer, BioDlink, remarked, "We are proud to have supported Lepu Biopharma in the development and production of the world’s first approved EGFR-Targeting ADC drug—which is also the first fully CDMO-manufactured ADC successfully launched in China. This achievement is not only a breakthrough for the industry but also a testament to our shared vision and execution excellence. This partnership strongly validates BioDlink’s commercial-ready capabilities and quality systems."

Dr. Ziye Sui, Executive Director and CEO of Lepu Biopharma, commented, "BioDlink has been far more than a traditional CDMO partner. In this collaboration, CDMO has meant Commitment, Dedication, and Mutual Objective. The team’s technical expertise and seamless collaboration were instrumental in the efficient launch of MEIYOUHENG. We look forward to deepening our partnership to deliver more innovative therapies to patients in China and around the world."

Looking ahead, BioDlink will continue to leverage its integrated CDMO platform to support global partners in accelerating the development and commercialization of biologics, including monoclonal antibodies, biosimilars, and complex molecules such as ADCs.

(Press release, BioDlink, NOV 21, 2025, View Source [SID1234660869])

On November 21, 2025 XOMA Royalty Corporation ("XOMA Royalty") (Nasdaq: XOMA) reported it has successfully completed its previously announced acquisition of all the outstanding common shares of LAVA Therapeutics N.V. ("LAVA") (NASDAQ: LVTX) with a nominal value of €0.12 per share ("Shares"). LAVA shareholders received $1.04 in cash per Share and a non-transferrable contingent value right ("CVR") per Share representing the right to receive certain cash payments, including (A) the right to receive, among other things, 75% of any net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs plus (B) the right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities.

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"The acquisition of LAVA Therapeutics reinforces XOMA’s philosophy of ‘strength in numbers’, adding two early-stage bispecific antibodies in collaboration with well-established oncology partners, Johnson and Johnson and Pfizer," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "The combination of future milestones and royalties from the LAVA programs has the potential to drive significant value creation for the LAVA CVR holders and XOMA Royalty over time."

The initial offer period and subsequent offer period expired one minute after 11:59 p.m. Eastern Time on Wednesday, November 12, 2025, and one minute after 11:59 p.m. Eastern Time on Thursday, November 20, 2025 (the "Final Expiration Date"), respectively. As of the Final Expiration Date, a total of 23,956,708 Shares were validly tendered, and not validly withdrawn, representing approximately 91.1% of the outstanding Shares as of the Final Expiration Date.

Following the acceptance for payment of all Shares tendered in the subsequent offering period, LAVA consummated a corporate reorganization resulting in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and CVR consideration per share as is provided in the tender offer, subject to applicable withholding taxes. Prior to the opening of trading on November 21, 2025, public trading of the Shares was suspended, and LAVA intends promptly to cause such Shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP and Loyens & Loeff N.V, who acted as U.S. and Dutch legal advisors, respectively. Leerink Partners acted as exclusive financial advisor to LAVA, and Cooley LLP and NautaDutilh N.V. served as U.S. and Dutch legal advisor, respectively, to LAVA.

(Press release, Xoma, NOV 21, 2025, View Source [SID1234660868])

On November 21, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025, at 4:00 p.m. ET at the Lotte New York Palace in New York City.

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Investors interested in arranging a meeting with company management during the conference should contact the Piper Sandler conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section of the Supernus Pharmaceuticals website at www.supernus.com. An archived replay of the webcasts will be available for 60 days on the Company’s website following the conference.

(Press release, Supernus, NOV 21, 2025, View Source [SID1234660867])

On November 21, 2025 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), reported positive tablet PK data from ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (NCT06961565).

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Pharmacokinetics (PK)

PAS-004 has demonstrated in the tablet formulation (4mg and 8mg cohorts):

Linear PK and dose-proportionality
PK curve with Cmax/Cmin ratio <2, with Cmax and Cmin above the IC50 (half-maximal inhibitory concentration) from our cellular assay

Long half-life (~57 hours)

Cohort 1 (4mg tablet) has demonstrated:

AUC: 1,120 ng·h/mL

Cmax: 58.1 ng/mL

Cmin: 37.6 ng/mL
Cohort 2 (8mg tablet) has demonstrated:

AUC: 2,290 ng·h/mL

Cmax: 118 ng/mL

Cmin: 75.4 ng/mL
Dose normalized exposures following once daily administration of PAS-004 tablets were approximately 3-fold higher than those following administration with the capsule formulation, resulting in the 8mg tablet area under the curve (AUC) and Cmax being slightly greater than those of the 22mg capsule. The tablet formulation has demonstrated less patient variability and a similar Tmax range when compared to the capsule formulation. This is consistent with the pre-clinical evaluation of the two formulations in the dog toxicology studies.

Graph 1 below represents the tablet PK curve at steady state for the 4mg and 8mg doses and Graph 2 below represents the 8mg tablet PK curve at steady state as compared to 22mg capsule dose at steady state from our ongoing Phase 1 trial in advanced cancer patients.

(Press release, Pasithea Therapeutics, NOV 21, 2025, View Source [SID1234660866])

On November 21, 2025 Olema Pharmaceuticals, Inc. ("Olema", or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported that the Company will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 2025 at 12:55 p.m. ET.

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Live webcasts and recordings of these presentations will be available, as permitted by the event host, in the Events and Presentations section of Olema’s investor relations website at ir.olema.com.

(Press release, Olema Oncology, NOV 21, 2025, View Source [SID1234660865])