On August 3, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that orelabrutinib, in combination with mesutoclax (ICP-248), has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with marginal zone lymphoma (MZL) who have received at least one prior therapy.

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Orelabrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases. With its high target selectivity, it minimizes off-target effects, thereby improving both safety and efficacy. Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Mesutoclax is the first BCL2 inhibitor granted BTD recognition in China for the treatment of mantle cell lymphoma (MCL) in patients previously treated with a BTK inhibitor. This is the second BTD granted to the novel BCL2 inhibitor.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "We are pleased that orelabrutinib in combination with mesutoclax has been granted BTD, which will help accelerate clinical trials to provide better treatment options for more patients."

Data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated that orelabrutinib in combination with mesutoclax achieved excellent efficacy and safety in patients with MZL who had received at least one prior therapy, with an overall response rate (ORR) of 100%.

MZL is an indolent B-cell non-Hodgkin’s lymphoma (NHL) that primarily affects middle-aged and elderly patients. The annual incidence of MZL is rising globally. After first-line treatment, patients with relapsed or refractor MZL lack effective treatment options.

The BTD aims to accelerate the clinical development and approval of new drugs that demonstrate significant clinical advantages. New drugs granted BTD are typically intended for diseases that are life-threatening or severely impair quality of life, and have demonstrated clear advantages in efficacy or safety during clinical trials.

(Press release, InnoCare Pharma, AUG 3, 2026, View Source [SID1234669630])

On August 3, 2026 Obsidian Therapeutics, Inc. ("Obsidian") (Nasdaq: OBX), a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported the completion of its previously announced transaction with Galera Therapeutics, Inc. ("Galera"). The combined company will operate under the name Obsidian Therapeutics, Inc., and its shares are expected to begin trading on Nasdaq on August 4, 2026 under the ticker symbol "OBX".

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Prior to closing the merger, Obsidian completed a previously announced oversubscribed private placement financing of $350 million in gross proceeds from a syndicate of new investors, including Balyasny Asset Management, Caligan Partners LP, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital and Trails Edge Capital Partners, and with participation from current Obsidian investors, including Atlas Venture, Deep Track Capital, Foresite Capital, Janus Henderson Investors, Logos Capital, Novo Holdings A/S, Paradigm BioCapital Advisors, Pivotal bioVenture Partners, RA Capital Management, RTW Investments, TCGX and Wellington Management, among other leading investment management firms.

The combined company’s cash and cash equivalents balance at closing, including the funds from the private placement financing, is anticipated to fund the combined company’s operations into the second half of 2028 and provide runway through key clinical milestones for Obsidian’s lead product candidate, OBX-115. These include Phase 1 data from the ongoing non-small cell lung cancer (NSCLC) trial expected in the first half of 2027, and topline data from the melanoma registration-enabling trial, which are expected by year-end 2027. The combined company will also continue to support Galera’s pipeline.

"The completion of the merger with Galera and closing of our $350 million private placement mark a transformative milestone that propels Obsidian into its next stage of growth," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "With a strong financial position backed by a syndicate of leading biotechnology investors, robust leadership team, and promising early Phase 2 clinical data from our lead product candidate, OBX-115, we are well-positioned to deliver best-in-class TIL cell therapies to patients with solid tumors. We look forward to continuing to advance OBX-115 through the clinic and we are on track to begin enrolling patients with immune checkpoint inhibitor-resistant advanced melanoma in the registration-enabling cohort of our multicenter study in mid-2026."

Obsidian leverages its cytoDRiVE platform to develop engineered TIL cell therapies. OBX-115 is a novel engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 and designed to deliver an improved, patient-centric treatment regimen. OBX-115 has the potential to reduce overall treatment burden with the option for minimally invasive core needle biopsy tumor tissue procurement, exclusively low-dose lymphodepletion compatible with outpatient administration and elimination of IL2 in the treatment regimen.

OBX-115 has been granted Fast Track and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor therapy. OBX-115 is currently in a Phase 2 clinical trial for the treatment of advanced melanoma and a Phase 1 clinical trial for the treatment of NSCLC (NCT06060613).

Transaction Details

Prior to the closing of the transaction, Galera effected a 1-for-200 reverse stock split of its common stock. In connection with the closing of the transaction, Galera issued a non-transferable contingent value right (a "CVR") to Galera stockholders of record as of July 31, 2026, which does not include the former holders of shares of Obsidian or the private placement investors, representing the right to receive contingent payments upon the occurrence of certain events. Pursuant to the merger agreement and based on the final exchange ratio in each of the mergers, at the closing of the mergers, former Galera stockholders own approximately 1.2%, and former Obsidian stockholders own approximately 51.6%, and investors in the concurrent financing own approximately 47.2% of the combined company’s outstanding common stock.

Leerink Partners served as the exclusive financial advisor and Goodwin Procter LLP served as legal counsel to Obsidian. Leerink Partners, TD Cowen, Piper Sandler, William Blair and LifeSci Capital acted as placement agents in connection with the concurrent private placement financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to the placement agents. Sidley Austin LLP served as legal counsel to Galera. Lucid Capital Markets provided a fairness opinion to Galera’s Board of Directors.

(Press release, Obsidian Therapeutics, AUG 3, 2026, View Source [SID1234669629])

On August 3, 2026 Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported the activation of a third clinical site for its ongoing STARLIGHT-1 Phase I/II clinical trial evaluating EB103, a CD19-Redirected ARTEMIS T-cell therapy, in patients with relapsed or refractory ("R/R") B-cell non-Hodgkin’s lymphoma ("NHL"). The new site, Oregon Health & Science University in Portland, Oregon, has begun screening and enrolling patients.

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"The activation of Oregon Health & Science University, a leading academic medical center, reflects the continued momentum of our STARLIGHT-1 trial," said Cheng Liu, CEO of Estrella Immunopharma. "By collaborating with experienced clinical centers, we are advancing our goal of developing and expanding access to innovative therapies designed to improve outcomes for patients with R/R B-cell NHL."

The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the recommended Phase II dose ("RP2D") in subjects (≥ 18 years of age) who have R/R B-cell NHL. Data from this expansion cohort will be used to determine the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center, Baylor Scott & White Research Institute, and Oregon Health & Science University. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.

About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. (Eureka), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, such as EB103, allows it to be activated and regulated upon engagement with cancer targets through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.

(Press release, Estrella Immunopharma, AUG 3, 2026, View Source [SID1234669628])

On August 3, 2026 Forlong Biotechnology, a clinical-stage biotech company focused on developing transformative cytokine therapies for patients with severe unmet needs, reported that its manufacturing partner, JOINN Biologics, has successfully completed production of the FL115 pivotal batch, which will support the company’s upcoming Phase III clinical trial in non-muscle invasive bladder cancer (NMIBC).

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FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein. Fbody is a single-chain Fc engineered to preserve FcRn affinity while eliminating binding to FcγRs and complement systems, with the goal of optimizing protein half-life and biodistribution. FL115 drug substance and drug product have demonstrated excellent stability and solubility at concentrations up to 20 mg/mL, supported by a robust, low-cost GMP manufacturing process.

A clinical study of FL115 (NCT07122414) in BCG-unresponsive NMIBC is ongoing. Following the first patient dosing in August 2024, 10 patients have been dosed with FL115 alone and 52 patients have been dosed with FL115 at 3 dose levels in combination with BCG, all via intravesical delivery.

"FL115 in combination with BCG has shown impressive safety and efficacy data in patients with BCG-unresponsive NMIBC, with the potential to be the best-in-disease therapy," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology. "Successfully manufacturing and releasing the pivotal batch is an important milestone for the FL115 program, and we greatly appreciate the professional expertise and diligent effort of JOINN Biologics as our manufacturing partner. Together, we will advance FL115 into the pivotal Phase III clinical trial for NMIBC in 2027."

About FL115

FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein designed to enhance anti-tumor immunity through IL-15-mediated signaling on NK and CD8+ T cells, while minimizing the complexity associated with an Fc domain. FL115 has demonstrated significant anti-tumor activity in vivo, both as a monotherapy and in combination therapy, and can be manufactured through a robust, efficient process with excellent product stability. Clinically, FL115 has shown a favorable safety profile and preliminary clinical responses as a monotherapy, and has best-in-class potential to synergize with current and emerging T cell–targeting immunotherapies through combination approaches that could meaningfully improve treatment outcomes for patients.

FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase II clinical trial evaluating safety and preliminary efficacy in patients with non-muscle invasive bladder cancer (NMIBC), and in combination with an anti-PD-1 monoclonal antibody in a Phase I clinical trial evaluating safety and preliminary efficacy in patients with advanced solid tumors. A Phase I clinical trial of FL115 subcutaneous injection is also being initiated in Australia.

(Press release, Forlong Biotechnology, AUG 3, 2026, View Source [SID1234669627])

On August 3, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), for the treatment of neuroendocrine carcinomas (NECs). NECs are aggressive malignancies that frequently express DLL3. There are no available targeted therapies and no approved standard of care for NECs in previously treated patients.

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"Zoci has now received important regulatory designations around the world, signifying its potential to become an important new therapeutic option for patients with multiple types of cancer with DLL3 expressions." said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Given the need among the NEC patient community, we are focused on efficiently advancing our clinical programs for this investigational DLL3-targeting ADC."

The U.S. FDA previously granted Fast Track designation (FTD) to zoci for extrapulmonary NECs (epNECs), as well as FTD and ODD to zoci for small cell lung cancer (SCLC), the most significant pulmonary NEC and one of the most aggressive and lethal solid tumors.1,2 The European Medicines Agency (EMA) has also granted ODD to zoci for pulmonary NECs.

Benefits of the ODD include eligibility for certain development incentives, including a waiver of the Prescription Drug User Fee Act registration application fee; tax credits for certain clinical trials; and the potential to receive a seven-year U.S. market exclusivity period granted upon product approval.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in many neuroendocrine carcinomas, such as small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNEC), and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second- and third-line SCLC, first-line SCLC, and epNECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, support its potential role as a new standard of care in previously treated extensive-stage SCLC as well as epNEC, and a backbone DLL3-targeting antibody-drug conjugate (ADC) in first-line combination regimens, including those that reduce the burdens of chemotherapy, such as checkpoint inhibitors and T-cell engagers.

(Press release, Zai Laboratory, AUG 3, 2026, View Source [SID1234669626])