Oncology Drug Research, Development, and Manufacturing
Pharmaceutical Manufacturer
01 Roche Pharma China's Generic Drug Product Line Adjusted Again
On February 28, a relevant official from Roche Pharma China confirmed to CPhI China that Roche China's anti-infective and osteoporosis product lines have been successfully merged.
Roche China stated that this organizational restructuring does not involve any layoffs. The former head of the infectious disease field will now lead the strategic and product excellence launch team, while the former head of the osteoporosis field will continue to lead the new osteoporosis treatment and infectious disease treatment teams.
Starting from 2020, Roche launched the "Agile Transformation," followed by news of personnel changes and team adjustments being successively reported.
In July 2021, Roche Pharma announced that Bian Xin, President of its China division, would take over Zhou Hong's responsibilities starting October 1, 2021, becoming the new "leader" of Roche China.
Roche China announced that after completing its transformation in October last year, there will be no large-scale organizational adjustments from October 1, 2021 to October 2022.
On April 29, 2021, Roche Pharma China announced that its innovative influenza drug, Xofluza (Chinese generic name: Baloxavir Marboxil), had been officially approved by the National Medical Products Administration. This is the second anti-influenza drug launched by Roche in the Chinese market following "Tamiflu."
Although Roche's "Tamiflu" (Oseltamivir Phosphate Capsules) entered China in 2002, from the current competitive landscape of the oseltamivir market, Dongyang Guangyao’s oseltamivir has remained dominant. Public data shows that in 2017, Dongyang Guangyao's oseltamivir held over 90% of the market share in China, while Roche's "Tamiflu" accounted for less than 7%.
Currently, the price of Baloxavir Marboxil in China is 498 yuan (specifications: 20mg*2 tablets/box). In 2021, it was included in the medical insurance catalog, and the price of Baloxavir Marboxil dropped to around 222 yuan for the 20mg*2 tablets/box scale.
Some industry insiders believe that the market for baloxavir marboxil has broad development potential. As an innovative anti-influenza drug, it requires only a single dose for the entire treatment course and is effective against both influenza A and B, offering clear advantages and is expected to significantly impact the existing anti-influenza drug market.
In the field of osteoporosis, Rocaltrol is a medication used for its treatment. Against the backdrop of an aging population in China, osteoporosis drugs have significant market potential. Previously, Rocaltrol had already been included in the procurement list of the "Eight Provinces and Two Regions" alliance.
Against the backdrop of medical insurance and bulk procurement, both of Roche's products are expected to achieve further sales growth subsequently.
02 Fierce Competition in the Oncology Drug Market
Against the backdrop of structural adjustments, Roche China is also currently facing pressure from competition in the oncology drug market.
Financial reports show that Roche Pharma China's pharmaceutical business revenue in 2021 was 3.276 billion Swiss francs, accounting for 7.3% of Roche's global pharmaceutical business revenue, a year-on-year increase of 4%.
In the oncology business segment, due to the continued impact of biosimilars in 2021, Roche's "old troika" — Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab) — declined by 38%, 37%, and 28% respectively, totaling 7.749 billion Swiss francs, which is nearly a 35% reduction compared to 2020.
Although Roche Pharma's Tecentriq, Kadcyla, and Alecensa (all of which are oncology drugs) achieved growth of 24%, 16%, and 18% respectively, the overall revenue of the oncology business segment still declined by nearly 11%.
Roche Pharma China stated that, by 2020, Roche had already established a portfolio of 22 products in China, covering eight therapeutic areas, including oncology, anti-infectives, antivirals, transplantation, and immunology/rheumatology, among other key therapeutic fields. Currently, eight targeted therapies — Herceptin, Avastin, Tarceva, Zelboraf, Alecensa, Perjeta, Mabthera, Gazyva — and two biologics — Actemra and Gazyva — have been included in the National Reimbursement Drug List (NRDL).
Taking Roche's "old three horses" as an example, it is not difficult to see the fierce competition in the oncology drug market.
Data from MiNe Network shows that in recent years, the sales of Bevacizumab Injection at China’s public medical institutions have grown rapidly, surpassing 4 billion yuan in 2020. In the first half of 2021, year-on-year growth exceeded 80%. Currently, there are six manufacturers of this product. However, Roche and Qilu have almost divided the entire market in China between them.
It is worth mentioning that, with the rapid development of pharmaceutical companies in China, the market share of Roche's Bevacizumab Injection has quickly declined, from dominating the market in 2018 to falling below 40% in the first half of 2021. Qilu Pharmaceutical’s Bevacizumab Injection was approved in 2019 as the first domestically produced product of its kind in China. Initially holding less than 1% of the market share upon launch, it had successfully captured 57.48% of the market by the first half of 2021, surpassing Roche.
Recently, Biospace, a well-known media website in the biopharmaceutical industry, announced the top 10 best-selling anti-tumor drugs globally in 2021. Five products from Roche made the list: Perjeta ($4.28 billion), Tecentriq ($3.58 billion), Avastin ($3.3 billion), Herceptin ($2.91 billion), and Rituximab ($2.71 billion). However, Merck's Keytruda achieved sales of $17.18 billion in 2021, and it is expected to break through the $20 billion mark in 2022.
The oncology drug market has always been highly competitive. Undeniably, amidst a crowded field and intensifying competition, Roche Pharma China's oncology drugs are facing significant challenges. How Roche plans to address this pressure in the future will be closely monitored by CPhI China.