On April 22, 2026 Hengrui Pharma reported steady growth in the first quarter of 2026. In Q1 2026, the Company recorded revenue of RMB 8.14 billion, up 12.98% year-over-year, while net profit attributable to shareholders increased by 21.78% to RMB 2.28 billion. Innovative drugs remained the key growth driver, generating RMB 4.53 billion in revenue, up 25.75% year-over-year and accounting for 61.69% of total pharmaceutical sales.

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The Company continued to advance its innovation-driven strategy with sustained R&D investment and solid pipeline progress. R&D investments in Q1 2026 totaled RMB 2.22 billion, representing for approximately 27.32% of revenue.

During the period, three innovative products and new indications were approved in China, which included an anti-PD-L1/TGF-βRII bi-functional fusion protein and an indication expansion for HER2-targeting ADC.

In terms of pipeline advancement, the Company obtained 26 clinical trial approvals and had 8 new drug applications accepted in China across key therapeutic areas including oncology, metabolic, cardiovascular, and immunological diseases.

Business development has become a recurring and increasingly important growth driver, with RMB 787 million in out-licensing revenue recognized during the quarter, primarily from the collaboration with GSK. Since 2023, Hengrui Pharma has completed 12 overseas business development transactions, including out-licensing, NewCo structures, and strategic alliance models.

A key milestone during the period was the successful Nasdaq listing of Kailera Therapeutics (NASDAQ: KLRA), a NewCo company built around Hengrui Pharma’s GLP-1-based assets. This milestone reflects continued progress in executing the Company’s NewCo strategy, with Hengrui and Kailera working together to advance the global development of the GLP-1 portfolio.

Looking ahead, Hengrui Pharma will remain committed to innovation and globalization, strengthening its pipeline and advancing the development and commercialization of innovative therapies to benefit patients worldwide.

(Press release, Hengrui Pharmaceuticals, APR 22, 2026, View Source [SID1234664700])

On April 22, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV; FSE: 7JO0), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, reported the presentation of new preclinical data from two of its lead programs at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 17–22 in San Diego, California.

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The data, presented across two poster sessions at the world’s premier cancer research forum, advance Rakovina’s AI-driven pipeline targeting DNA damage response (DDR) vulnerabilities in hard-to-treat solid tumors. Both programs leverage generative AI platforms to address longstanding limitations of existing cancer therapies, including poor central nervous system (CNS) penetrance and the toxicity burden of drug combination regimens.

Novel Brain-Penetrant Dual ATR-mTOR Inhibitor Demonstrates In Vivo Efficacy in PTEN-Deficient Cancers

The first poster, titled A Novel Brain-Penetrant Dual ATR-mTOR Inhibitor for PTEN-Deficient Cancers (Presentation #1743, DNA Damage and Repair 2 session, April 20), presented preclinical data from Rakovina’s program to develop first-in-class CNS-penetrating molecules that simultaneously inhibit ATR and mTOR, two key drivers of survival in PTEN-deficient cancer cells. The program was developed in collaboration with Variational AI (Vancouver, BC) using the Enki generative AI platform.

PTEN deficiency is found in up to 40% of gliomas and 63% of breast cancers, which frequently metastasize to the brain. Simultaneous inhibition of ATR and mTOR is a rational therapeutic strategy in PTEN-deficient tumors, as PTEN loss activates both ATR-dependent DNA damage signaling and mTOR-driven cell survival pathways. However, no approved therapy directly addresses this dual vulnerability with effective CNS penetrance.

Using the Enki latent diffusion model to simultaneously optimize potency, selectivity, CNS penetrance, and ADMET properties, Rakovina generated and synthesized a curated set of novel small-molecule dual ATR-mTOR inhibitor candidates. Key findings presented at AACR (Free AACR Whitepaper) 2026 include:

Enzymatic potency: Candidate compounds demonstrated equal or greater inhibition of recombinant ATR and mTOR enzymes compared to reference compounds ceralasertib and tuvusertib.
Selectivity: Candidates are equally or more selective against PIKK family enzymes than the reference compounds ceralasertib and tuvusertib.
Cell viability inhibition: Candidates inhibit cell viability of D283 medulloblastoma cells equally or more than reference compounds. A prototype lead candidate inhibited cell viability of both PTEN wild-type and PTEN-deficient cancer cell lines.
Metabolic stability: After 45 minutes of incubation with human liver microsomes, candidate compounds demonstrated strong metabolic stability.
CNS penetrance: Pharmacokinetic profiling following intraperitoneal administration in mice confirmed varying but measurable levels of CNS penetrance across candidates, with brain-to-plasma ratios broadly consistent with Enki AI predictions.
In vivo efficacy: In a subcutaneous LNCaP prostate tumor model, a prototype lead candidate significantly prolonged tumor doubling time compared to vehicle control, with equal potency to reference compound ceralasertib. Critically, the Rakovina candidate was better tolerated than ceralasertib, demonstrating less weight loss with daily dosing and no signs of hematological toxicity at terminal complete blood count analysis.
Optimization of candidate inhibitors is ongoing.

Novel AI-Designed Lipid Nanoparticle Formulation of kt-3283 Successfully Characterized

The second poster, titled Development of a Lipid Nanoparticle Formulation of the Bifunctional PARP and HDAC Inhibitor Kt-3283 (Presentation #6373, Drug Delivery session, April 21), presented preclinical formulation data on pLNP/kt-3283, developed in collaboration with NanoPalm (Riyadh, Saudi Arabia) using the EnsaliX AI platform.

kt-3283 integrates PARP inhibition and HDAC-mediated chromatin remodeling into a single compound, thereby improving the PARP efficacy, and eliminating the need for combination drug regimens and their associated toxicity risks. While kt-3283 has demonstrated potent anti-tumor activity across multiple tumor types in prior in vitro studies, its clinical viability has been limited by bioavailability and metabolic stability challenges. The pLNP formulation has been specifically designed to address these limitations.

Data presented confirm the successful assembly of the EnsaliX-designed patterned lipid nanoparticles. Physicochemical characterization confirmed uniform particle size, stable colloidal behavior, and a structured surface texture predicted to enhance cellular uptake. The pLNP/kt-3283 formulation demonstrated structure and particle size consistency supporting further biological evaluation.

Next steps include in vitro and in vivo characterization to confirm activity against PARP and HDAC enzymes, determine ADME properties, and evaluate efficacy in tumor models.

"Presenting at AACR (Free AACR Whitepaper) is a meaningful milestone for our team, and these results represent a genuine step forward for both programs," said Kim Oishi, Chief Executive Officer of Rakovina Therapeutics. "The in vivo efficacy data for our ATR-mTOR inhibitor are particularly encouraging. The compound demonstrated potency comparable to an established reference compound while exhibiting a meaningfully improved tolerability profile. That is exactly the differentiation we are building toward. Combined with the initial characterization of our LNP formulation for kt-3283, we believe these results reinforce the potential of our AI-driven pipeline and support a path toward IND-enabling studies."

Rakovina’s AI-powered discovery approach leverages generative AI platforms to evaluate billions of potential drug candidates at a pace not achievable through traditional methods. These capabilities are supported by the company’s access to the University of British Columbia’s lab infrastructure, enabling rapid in-house testing of lead compounds.

"These results demonstrate that our strategy of integrating AI-guided design with biological validation, is working as intended," said Dr. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "For the ATR-mTOR program, our candidate inhibitors are tracking closely with the AI predictions for potency, selectivity, and CNS penetrance and our in vivo results give confidence in the direction of this program. For kt-3283, we have demonstrated that the EnsaliX-designed LNP formulation produces a well-characterized nanoparticle. The structured surface and organized phospholipid assembly we observed are precisely the properties expected to enhance nanoparticle stability and cellular uptake of kt-3283. Both programs have clear next steps, and we are moving forward with purpose."

The data presented at AACR (Free AACR Whitepaper) 2026 reinforce the progress of Rakovina’s AI-enabled DDR inhibitor pipeline and inform the next phase of preclinical development for both programs. For the ATR-mTOR program, further optimization of candidate inhibitors is ongoing. For the kt-3283 LNP program, the company will advance in vitro and in vivo studies to further characterize biological activity prior to evaluating efficacy in tumor models.

Rakovina intends to use these findings to advance best-in-class lead candidates toward IND-enabling studies in collaboration with pharmaceutical partners.

(Press release, Rakovina Therapeutics, APR 22, 2026, View Source [SID1234664716])

On April 22, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("Outlook Therapeutics" or the "Company"), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16,129,033 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.31 per share of common stock (or per pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 16,129,033 shares of common stock at an exercise price of $0.31 per share. The unregistered warrants will become exercisable on the later of (i) the date of stockholder approval of the issuance of the shares underlying the warrants and (ii) the effective date of an amendment to the Company’s certificate of incorporation to increase the authorized shares of the Company and will expire five years following the later of (x) the date the unregistered warrants are first exercisable and (y) the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about April 23, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, would be approximately $5.0 million. No assurance can be given that any of the unregistered warrants will be exercised for cash. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes.

The shares of common stock (or the pre-funded warrants in lieu thereof and the pre-funded warrant shares issuable thereunder) (but excluding the unregistered warrants and the shares of common stock issuable thereunder) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278340) that was originally filed with the Securities and Exchange Commission (the "SEC") on March 28, 2024 and became effective on April 5, 2024. The offering of the shares of common stock (or the pre-funded warrants in lieu thereof and the shares of common stock issuable thereunder) in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered and sold by the Company in a transaction not involving a public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock issuable thereunder, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the shares of common stock issuable thereunder may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company also has agreed to amend certain outstanding warrants to purchase up to an aggregate of 2,142,854 shares of the Company’s common stock that were previously issued to an investor on January 16, 2025, with an exercise price of $2.26 per share, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.31 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the amended warrants and will expire five years from the effective date of such stockholder approval.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Outlook Therapeutics, APR 22, 2026, View Source [SID1234664685])

On April 22, 2026 Prestige Biopharma IDC, the innovative drug research institute of Prestige Biopharma, reported that it has filed a patent for ‘IDC224,’ a next-generation subcutaneous (SC) delivery platform designed to simultaneously enhance the administration convenience and therapeutic efficacy of antibody therapeutics.

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While most current antibody therapeutics are administered via intravenous (IV) infusion—typically requiring more than an hour and dedicated medical assistance—subcutaneous (SC) administration offers a rapid, highly convenient alternative for patients. Given the high patient convenience and the mitigation of risks associated with repeated vascular access, the global pharmaceutical and biotechnology industry is witnessing a strategic shift from IV to SC delivery methods.

However, antibody therapeutics face significant technical barriers regarding the stable delivery of high-concentration formulations, necessitating advanced engineering for successful SC conversion. Prestige Biopharma IDC has addressed these challenges with the development of its proprietary IDC224 technology.

The IDC224 platform is characterized by a unique liquid-to-gel transition mechanism; the drug is administered in a liquid state and subsequently transforms into a gel upon exposure to body temperature. This process facilitates the sustained release of the drug, effectively extending its therapeutic duration and reducing dosing frequency. Furthermore, the platform enables the uniform loading of high-concentration antibodies, thereby maximizing delivery efficiency. It also secures a strong competitive edge in safety by utilizing biocompatible and biodegradable materials.

The project lead overseeing the development of IDC224 stated, "This platform was engineered to optimize the mode of administration, drug delivery efficiency, and patient convenience in tandem. In pre-clinical studies applying this platform to gastric, ovarian, and breast cancer models, we confirmed improved therapeutic efficacy compared to conventional methods." The representative added, "This patent is a follow-up to our existing composition patent and holds significant value as a ‘use patent,’ which newly defines the anticancer efficacy achieved through this specific composition."

Notably, this technology is designed to facilitate the potential SC conversion of Tuznue, Prestige Biopharma’s trastuzumab biosimilar, which is currently approved in Europe in its existing formulation. This technology therefore holds substantial strategic value in further strengthening product competitiveness and enabling future differentiated administration options for patients and healthcare providers.

A spokesperson for Prestige Biopharma IDC remarked, "The IDC224 platform is designed not only to enhance the durability of an antibody’s therapeutic effect but also to improve ease of administration. We plan to expand the application of this technology to a diverse portfolio of antibody therapeutics in the future."

About Tuznue

Tuznue is a biosimilar of Herceptin (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

(Press release, Prestige BioPharma, APR 22, 2026, View Source [SID1234664701])

On April 22, 2026 Oxford Vacmedix (OVM), the UK biotech company developing novel immunotherapies to treat cancer, reported the successful completion of the Phase 1 trial of OVM-200. The primary endpoint for safety has been met as well as the secondary endpoints for immune response and dose selection. In addition, there are early observations of clinical efficacy in NSCLC and in prostate cancer.

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This Phase 1 clinical trial of OVM-200 is a multicentre, open‑label, first‑in‑human evaluation of OVM‑200, an immunotherapy developed using Oxford Vacmedix’s Recombinant Overlapping Peptide (ROP) therapeutic platform. 36 Patients with advanced NSCLC (non‑small cell lung cancer), ovarian cancer, or prostate cancer and with no HLA restrictions, were treated in the trial. The results show:

Excellent Safety Profile (primary endpoint): OVM‑200 is very well tolerated with no serious adverse drug reactions or no dose‑limiting toxicities. The only adverse effects were Grade 1 injection‑site reactions.
Very strong Immunogenicity (secondary endpoint): the immune response for both antibodies and for T cells were very strong even in an advanced Stage IV patient population. The immune responses data conclusively demonstrates the dual mode of action of the ROP technology.
Therapeutic Dose established (secondary endpoint) based on the immune response, the 2mg dose was chosen for Phase 1b with expanded immunisations of up to 11 doses of 2mg being used.
Early observations of clinical efficacy with stable disease in NSCLC and PSA response in prostate cancer.
Professor Shisong Jiang, founder and Chief Scientific Officer of Oxford Vacmedix, said:

We are delighted to be able to confirm these results for this Phase 1 trial of OVM-200 and with this first step toward providing accessible immunotherapy for all patient types. This progress has only been possible through the participation of the patients in the trial and the dedication of the staff in the clinics.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

This completion of the clinical trial of OVM-200 marks an important milestone for the company and shows the potential of the ROP technology. We are very pleased to have reached this significant inflection point and are already in discussion with Series B investors to fund Phase 2 trials for OVM-200.

(Press release, Oxford Vacmedix, APR 22, 2026, View Source;utm_medium=rss&utm_campaign=successful-ovm-200-phase-1-trial [SID1234664686])