Shanghai Henlius Biotech, Inc.

SHANGHAI, China & JERSEY CITY, NJ, USA I September 30, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study ( NCT05346224 ) aimed to compare the efficacy and safety of HLX11 with reference Perjeta ® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta ® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC). The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study was met. Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant, first-line, and adjuvant treatment for certain advanced HER2-positive breast cancer. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has proactively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac ® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . SOURCE: Organon

In the ADC renaissance of the last few years, Japan’s venerable pharma company Daiichi Sankyo has won many of the headlines. But if MediLink Therapeutics has its way, Chinese biotechs will cement the treatments’ dominance in oncology — and prove that China’s new generation of drugmakers can truly compete on the global stage. MediLink has raised $120 million in funding and counts BioNTech and Roche as partners. The Suzhou-based company is at the forefront of a dealmaking wave in which multinational pharma companies have increasingly looked to China as a source of early drug candidates. And MediLink’s licensing deals with multinational pharmas are a bright spot amid growing US-China tensions that have cast a chill over much of the local industry’s work with US companies. The biotech, founded in 2020, came on the scene just as “nearly every pharma was looking for ADCs” again after the drugs had fallen out of favor a decade prior, said Jiaqiang Cai, MediLink’s co-founder and chief scientific officer. That wasn’t always the case. Cai previously worked at Sichuan Kelun-Biotech, which began pursuing ADCs in 2013 after the FDA approval of Roche’s Kadcyla sparked an ADC me-too frenzy in China. While he believed Kelun had a me-better molecule, at 2019’s JP Morgan conference in San Francisco, everyone turned him down for meetings to talk about licensing deals. They saw no future in ADCs, and “nobody believed everything we did in China at that time,” he said. A few months later, Merck came calling after AstraZeneca’s up to $7 billion ADC deal with Daiichi Sankyo stunned the industry. Merck licensed Kelun’s TROP2 ADC and eventually inked two more deals for other programs, each with billions of dollars in potential milestones. By then, Cai had left to work for another domestic pharma company in Shanghai. But Tony Xue, his former ADC partner at Kelun, wondered if they could repeat the success with a new startup and a new platform. “Kelun’s technology is actually very good for TROP2. But for many other targets, [it’s] probably too unstable, and also [the] potency is too high,” Cai said. That fine balance of delivering enough chemotherapy to kill cancer without poisoning the rest of the body has long been the key challenge for ADCs. MediLink works with a version of the standard antibody-linker-payload combo that is stable in healthy tissue and doesn’t require internalization of the antibody — meaning its cancer-killing drugs can be unleashed outside the cell, removing some barriers to efficacy. The concept isn’t new. But the way MediLink turned it into reality is emblematic of the fast, iterative engineering that’s helped many Chinese startups get ahead in the drug discovery race. The tiny team led by Xue, Cai and COO Joey Xiao came up with six different ideas of how to structure the payload-linker complex, then hired a CRO to test them all in parallel. They got to work in December 2020. Three months later, in February 2021, they had a molecule that met their criteria. And in June of that year, optimization was complete. “During six months, they made 200 molecules for us. And only six chemists,” he said. Roche made MediLink the first partner for its Shanghai R&D group, and sees the startup “as a fast-growing China biotech with R&D expertise and proprietary ADC platform technology, including differentiated TOP1 inhibitor payload and linker,” a spokesperson for the Swiss drugmaker said. There can be downsides to speed: MediLink and BioNTech’s HER3 ADC was placed on a clinical hold by regulators earlier this year after patient deaths were deemed related to treatment. The serious toxicity arose as MediLink expanded the patient cohort in a short period of time. “We moved too fast,” Cai told Endpoints. But he said the companies also reacted swiftly to pause enrollment and notify regulators. They ended up adjusting the dose, and the hold was lifted in August . With money from the out-licensing deals, MediLink has been able to grow its team to almost 180 people, even though it hasn’t raised any new venture funding since closing a $70 million Series B in 2022. With many of MediLink’s assets already claimed by a partner (before BioNTech and Roche, it also struck deals with Zai Lab, Harbour BioMed and Henlius) the company’s leaders are hoping to keep some candidates in-house before considering more deals, which Cai said would likely happen at a later phase. “For anything you try to license out, you need to get the idea earlier than others, and then you have something other people don’t have,” he said. When asked about concerns that promising data from Chinese patients wouldn’t translate in trials outside the country, Cai noted that the much higher body weight for US patients could skew the pharmacokinetics, and different dose settings may be required in different countries. “I believe eventually it will work,” he said. Key investors: LYFE Capital, Qiming Venture Partners, Legend Capital, Loyal Valley Capital, Apricot Capital, C&D Emerging Capital, Highlight Capital Find the full list of 2024 Endpoints 11 winners here .

- HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC - HETRONIFLY® (serplulimab) is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC AHMEDABAD, India, Sept. 21, 2024 /PRNewswire/ -- Intas Pharmaceuticals Limited ("Intas") has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY® (serplulimab, approved as Hansizhuang in China), in European markets. Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug status designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC). Serplulimab will be commercialised by Intas through its subsidiary, Accord Healthcare Ltd (Accord), across more than 30 countries in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe. This positive opinion from CHMP marks another step closer for both Henlius and Intas to provide serplulimab for patients in Europe. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius' patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide." Paul Tredwell, Executive Vice President of EMENA at Accord, said "I am thrilled with the CHMP's positive opinion. This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis." Alex Falgas, Senior Vice President of Business Development at Accord said "The CHMP's positive opinion on serplulimab is a pivotal moment in our mission to provide world-class cancer treatments to patients in Europe. This strengthens our oncology portfolio and reinforces Accord's commitment to alleviating the global cancer burden, ensuring greater access to innovative therapies for those in need." According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer cases, and is associated with early metastasis, rapid disease progression, and an extremely poor prognosis. The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC. References: [1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834 About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. About Intas Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US. Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US. Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently; Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products. 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