On March 4, 2024 AnHeart Therapeutics ("AnHeart"), a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer, and Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted a second New Drug Application (NDA) for taletrectinib, a next-generation ROS1 tyrosine kinase inhibitor (TKI) (Press release, AnHeart Therapeutics, MAR 4, 2024, View Source [SID1234640746]). This NDA is for taletrectinib as a first-line treatment for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not previously been treated with ROS1 TKIs.

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In 2023, China’s NMPA accepted taletrectinib’s first NDA and granted Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have been previously treated with ROS1 TKIs. Both NDAs in China are based on positive results from the Phase 2 TRUST-I (NCT04395677) trial. Data from an interim analysis of TRUST-I were presented at the European Lung Cancer Congress (ELCC) 2023 and additional data from TRUST-I is planned to be presented at an upcoming medical meeting in 2024.

"I am pleased this second NDA for taletrectinib has been accepted in China. We need additional options for our patients who are newly diagnosed with advanced or metastatic ROS1-positive NSCLC that may improve upon the first-generation medicines," said Professor Caicun Zhou, Principal Investigator and Oncologist at Shanghai Pulmonary Hospital.

"The acceptance of this NDA in China supports our belief in taletrectinib as a first-line treatment for people with advanced or metastatic ROS1-positive NSCLC, and we are excited by the opportunity to bring a potentially transformative medicine to people earlier in their treatment journey," said Bing Yan, MD, President, AnHeart China. "We plan to work closely with our partners at Innovent and regulatory authorities in China to continue progressing taletrectinib as part of our mission to improve the lives of people with cancer."

"Given the clinically demonstrated benefits of taletrectinib in the TRUST-I trial, we are pleased to see the second NDA accepted by the NMPA of China," said Dr. Hui Zhou, Senior Vice President of Innovent. "We will continue close communications with our partner AnHeart Therapeutics and regulatory authorities in China, hoping to bring this new generation of targeted therapy to all appropriate patients with ROS1-positive NSCLC as a standard initial treatment option."

About Taletrectinib

Taletrectinib is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor.

Taletrectinib is being evaluated for the treatment of ROS1-positive NSCLC patients in two Phase 2 trials, TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global pivotal trial.

In 2022, taletrectinib was granted Breakthrough Therapy Designation by the CDE of China’s NMPA for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 TKI naïve as well as those who have previously been treated with ROS1 TKIs.

Taletrectinib has also been granted Breakthrough Therapy Designation in the United States for the treatment of ROS1-positive NSCLC by the U.S. Food and Drug Administration (FDA).

In 2021, AnHeart and Innovent entered into an exclusive license agreement for the co-development and commercialization of taletrectinib in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

About ROS1-Positive NSCLC in China

More than one million people globally are diagnosed with NSCLC annually, the most common form of lung cancer. It is estimated that approximately 3% of people with NSCLC in China are ROS1-positive. There are two approved first-generation TKIs for people with newly diagnosed advanced or metastatic ROS1-positive NSCLC in China and no approved therapies for people whose ROS1-positive NSCLC has progressed following treatment with these medicines. Up to 35% of people newly diagnosed with metastatic ROS1-positive NSCLC have tumors that have spread to the brain (brain metastases), increasing up to 55% for those whose cancer has progressed following initial treatment.

On March 4, 2024 The European Society of Gynecological Oncology (ESGO) 2024 Conference reported that it has recently made selected abstracts available online (Press release, Qilu Pharmaceutical, MAR 4, 2024, View Source [SID1234640745]). The abstract (abstract # 251) that details results from the Phase II clinical trial (DUBHE-C-206) evaluating the efficacy and safety of Qilu Pharmaceuticals’ iparomlimab and tuvonralimab (QL1706) in cervical cancer was selected for oral presentation on 8 March, local time.

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Access the abstract here: View Source;trackid=548#!

This study was led by Professor Jihong Liu from the Sun Yat-sen University Cancer Center and Professor Hanmei Lou from the Zhejiang Cancer Hospital. This was a multi-center, single-arm, phase II study which recruited patients with recurrent or metastatic cervical cancer unresponsive to first-line platinum-based chemotherapy (with or without bevacizumab) and without prior immunotherapy. Participants received QL1706 at a dose of 5.0 mg/kg once every three weeks (Q3W). The study involved 38 medical centers across China and enrolled 148 patients, with a median follow-up of 11.0 months at the data cut-off. The primary endpoint, the objective response rate (ORR), as assessed by an Independent Evaluation Committee (IRC), was 33.8%, meeting the prespecified criteria. The disease control rate (DCR) was 64.9% and median progression-free survival (PFS) was 5.4 months. Overall survival (OS) was not reached. Treatment-related adverse events (TRAEs) occurred in 104 (70.3%) subjects, with 36 (24.3%) experiencing grade ≥3 TRAEs. Anemia (4.1%) was the most common TRAE. Treatment discontinuation due to TRAEs occurred in three patients (2.0%). TRAE leading to death didn’t occur.

The trial indicates that QL1706 is an effective and safe therapy for patients with recurrent or metastatic cervical cancer whose disease progressed after first-line standard of care. In August 2023, the China NMPA, Center for Drug Evaluation (CDE) accepted the new drug application for QL1706, making it the first MabPair product targeting PD-1 and CTLA-4 worldwide and a potential new treatment option for patients with cervical cancer.

On March 4, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in upcoming investor relations events (Press release, Ideaya Biosciences, MAR 4, 2024, View Source [SID1234640744]).

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Leerink Partners Global Biopharma Conference
Monday, March 11th, 2024 at 12:40 PM ET
• Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Andrew Berens, M.D., Senior Managing Director, Targeted Oncology

Jefferies Biotech on the Bay Summit
Tuesday, March 12th, 2024 at 8:00 AM ET
• Panel: "Novel Targeted-Oncology: Approaches, Advancements, & Future Directions", with participation by Yujiro S. Hata, Chief Executive Officer, hosted by Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology

A live audio webcast of conference events, as permitted by conference host, will be available at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

On March 4, 2024 Henlius (2696.HK) reported a positive profit forecast (Press release, Henlius Biopharmaceuticals, MAR 4, 2024, View Source [SID1234640743]). Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the "Reporting Period") and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management.

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Wenjie Zhang, Chairman and Executive Director of Henlius, said: "2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and cumulative effects of an integrated industrial chain of R&D, manufacturing, and commercialization, the company has improved its decision-making efficiency and speed-to-market, achieving a leapfrog development. Looking ahead, we will continue to improve quality, make new breakthroughs in our journey of quality development, and reach out toward new horizons."

Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: "Henlius has always been guided by clinical needs and adheres to an innovation-driven development strategy. We maintain strategic focus and strengthen our own differentiated advantages under challenging circumstances, achieving milestone breakthroughs in various areas, and driving a rapid growth. Standing at a new starting point for development, we will draw a new blueprint for growth and collaborate with partners along the industry chain to benefit more patients."

Hitting a record high by efficient and seamless collaboration

In 2023, Henlius further enhanced its self-sufficiency capabilities. Leveraging a forward-looking commercial layout and efficient market expansion, the company continuously advanced its product commercialization, improving product accessibility to maximize patient benefit. The competitiveness of the company’s two core products has continued to improve both domestically and internationally, which drives the revenue significantly and contributes to the high-quality development of the company.

HANQUYOU (trastuzumab, trade name in Europe: Zercepac; trade names in Australia: Tuzucip and Trastucip), the first China-developed monoclonal antibody biosimilar approved both in China and Europe, is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. HANQUYOU has become the China-developed biosimilar with the most marketing approvals, covering over 40 countries and regions up to now, including China, the UK, Switzerland, Australia, Singapore, Thailand, Argentina, Brazil, and Saudi Arabia. With its differentiated advantages such as dual dosage of 150mg and 60mg, preservative-free formulation, the product has rapidly expanded its market share in China, benefiting more than 170,000 Chinese patients to date. Notably, the Biologics License Application (BLA) for HANQUYOU has been accepted by the U.S. Food and Drug Administration (FDA) in the first half of 2023, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S. Furthermore, its New Drug Submission (NDS) was accepted by the Health Canada in July 2023, further expanding the product’s footprint in major markets of biologics in the U.S. and Europe.

HANSIZHUANG (serplulimab), the first anti-PD-1 monoclonal antibody (mAb) developed by Henlius, was launched in March 2022. Up to date, it has been approved for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC). It is also the world’s first anti-PD-1 mAb for the first-line treatment of small cell lung cancer (SCLC). In December 2023, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous (NSCLC) was accepted by the National Medical Products Administration (NMPA), with approval expected in the second half of 2024. With its breakthrough efficacy and differentiated advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and has increasingly strengthened its market competitiveness and influence. To date, it has completed tendering process on the procurement platform in all provinces of Chinese mainland and has been included in over 70 provincial/city-level supplementary commercial medical insurances, benefiting more than 55,000 patients. Additionally, Henlius has collaborated with many world-renowned pharmaceutical companies to further expand HANSIZHUANG’s global footprint, which now includes the U.S., Europe, Southeast Asia, MENA, and India. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. On the other hand, HANSIZHUANG’s Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to further support the BLA in the U.S., which encourages more Chinese medicines to go global.

Accelerating the pace to meet clinical needs in a multi-dimensional way

Innovation is the cornerstone of Henlius for its sustainable development. We deliver on the commitment to patient centricity and continuously deepen and implement the differentiated innovation strategy to build a diversified and high-quality product pipeline and accelerate the translation of research results to market and practice. Currently, our product pipeline includes about 60 molecules across mAb, polyclonal antibody (pAb), antibody-drug conjugate (ADC), fusion protein, and small molecule drug, of which more than 80% are self-developed. In 2023, the company accelerated global multicentre phase 3 clinical studies for marketed or late clinical-stage products, including HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with the first patients dosed in the U.S., the EU and other countries and regions. Meanwhile, the company is actively exploring novel targets and molecular mechanisms in more disease areas, promoting a number of potential first/best-in-class products, including the novel EGFR-targeting ADC HLX42 and PD-L1-targeting ADC HLX43, to enter into the phase 1 clinical research. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products, further accelerating its innovation layout.

As a global biopharmaceutical company, Henlius has continued to improve and enhance its large-scale production capabilities by establishing three production facilities, namely Xuhui Facility, Songjiang First Plant and Songjiang Second Plant, to form synergy and develop scale effects. The current commercial production capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2026, the total production capacity is expected to reach 144,000 liters, laying a solid foundation for company’s medium to long-term global commercial production and business development. In 2023, Henlius’ commercial production facilities and supporting quality management system have undergone/passed intensive on-site inspections and audits conducted by regulatory authorities and international business partners, including the U.S., the EU, PIC/S members Indonesia and Brazil, and Columbia, promoting the global launch of more products, thus benefiting more patients across the world.

Going forward, Henlius will continue to strengthen its innovation capabilities, fully enhance productivity, improve commercialization efficiency, to consolidate positive growth, create diversified growth engines, and pursue a higher-quality development path.

On March 4, 2024 Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, reported that it has entered into a securities purchase agreement with TCGX, an institutional accredited investor, to sell securities in a private placement financing (the "PIPE") for gross proceeds of $30 million, before deducting expenses (Press release, Nektar Therapeutics, MAR 4, 2024, View Source [SID1234640742]).

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In the PIPE, Nektar is selling 25 million shares of its common stock, in the form of a pre-funded warrant, at a price of $1.20 per share, representing a premium of approximately 80% to Nektar’s 30-day volume-weighted average price. The pre-funded warrant will have an exercise price of $0.0001 per share and will not expire.

The PIPE is expected to close on or before March 6, 2024, subject to customary closing conditions. Nektar has agreed to submit a registration statement filing for the underlying Common Stock no later than 90 days after the closing.

"We are pleased to bring on TCGX as a new high-quality, long-term investor in Nektar as we advance rezpegaldesleukin through our Phase 2b studies in atopic dermatitis and alopecia areata," said Howard Robin, President and Chief Executive Officer of Nektar Therapeutics. "We are on track to report topline data from these studies in the first half of 2025, which will represent significant inflection points for Nektar. Today’s financing further bolsters our financial position and extends the company’s cash runway well into the third quarter of 2026."

Rezpegaldesleukin is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory response and simultaneously restore immune balance by directly expanding functional T reg cells and engaging multiple immunoregulatory pathways.

The private placement is exempt from the registration requirements of the Securities Act pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act of 1933, as amended and Rule 506 of Regulation D of the Securities Act of 1933, as amended and in reliance on similar exemptions under applicable state laws.

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