He paused for a mont, his tone becoming earnest: "But the path forged by pioneers is often rugged and dangerous, and costly. Our target is to widen, strengthen, and illuminate this small road, allowing more researchers and pharmaceutical companies to safely and efficiently explore more branches and treat more diseases. Therefore, we are not competitors; we are road builders and ecological constructors. In fact, all the keystone modules of our platform have strictly avoided Ruixing’s patented core sequences and have fundantally differentiated in design logic. What we look forward to is a hundred flowers blooming, not a single one dominating."
His response was watertight, expressing respect, delineating boundaries, and painting an enticing vision.
At the small signing ceremony after the press conference, three leading dostic pharmaceutical companies signed strategic cooperation agreents with the platform, and several small and dium-sized enterprises also joined, as they could receive substantial funding and technical assistance from the program.
Wu Changde coped with congratulations from all sides, but his eyes occasionally glanced at his phone. There was a short ssage on the screen from an overseas number: "The first step was beautiful. Europe can start making contact."
He pressed the screen off, his smile unchanged.
...
On the sa afternoon in Geneva, Switzerland, in a café near the World Health Organization (WHO) building.
Lillian Windsor sat by the window, opposite Germany’s pharmaceutical regulatory representative Carl Schmidt, with nearly untouched coffee in front of them.
"The provisional guidelines have been issued, but the real test is just beginning." Carl stirred his coffee, "We’ve initially reviewed the technical plan of the Frankfurt Mirror Center, and the safety level is sufficient, but the definition of data access permissions is very vague. What is ant by ’the minimum scope necessary for clinical decision-making’? Who decides? Can Chinese personnel on the Joint Supervisory Committee access complete genomic data of European patients? These are all powder kegs."
"So detailed rules are needed, and even more so is trust," Lillian said. "Carl, you’ve been reviewing drugs for twenty years, have you ever seen a global multi-center clinical trial where the data never leaves the country of origin?"
"No, but in the past, data flowed to the United States or Switzerland, within the frawork."
"You an if it flows to China, it’s outside the frawork?" Lillian looked directly at him, "Or perhaps we’re still not ready deep down to accept a non-Western technology leader?"
Carl did not answer and looked out the window.
"I received an analysis report." Lillian took a tablet from her bag and pushed it across,
"If due to data issues, K Therapy’s full approval in Europe is delayed for six months, the model estimates that at least eight hundred to a thousand eligible late-stage patients will miss out on treatnt opportunities, about a third of whom might have had a chance for long-term survival. These are not numbers, Carl, they’re eight hundred to a thousand families."
Carl looked at the concise bar chart and case simulation images on the screen, his fingers tightened.
"I’m not resorting to emotional blackmail," Lillian’s tone softened, "I’m stating a cruel arithtic that regulators often have to face: absolute safety is ideal, but before the ideal is achieved, lives are slipping away. We need to find the best possible balance between ideal and reality."
"How do you suggest balancing it?"
"Accelerate the formulation of detailed rules, but simultaneously launch an ’expanded compassionate use’ program." Lillian was prepared, "Before the unlimited clinical trial and subsequent market launch are finally approved, allow well-screened, end-stage patients with no other options to use K Therapy under fully inford consent and close monitoring. This data would also be included in the regulatory frawork, thereby collecting real-world data from the European population while saving lives. The risks are controllable, and ethically defensible."
Carl pondered for a long ti: "This requires high coordination between EMA and the health departnts of various countries and a serious commitnt from the treatnt provider Ruixing to bear all additional monitoring costs."
"Mr. Huang Jiacai verbally committed to yesterday, willing to take on this responsibility," Lillian said. "They even proposed to fund and collaborate with Europe’s top hospitals to establish a dical team specifically responsible for monitoring and ergency response of compassionate use cases, they’ve made enough gestures."
Carl finally took a sip of his coffee; it was already cold, "Lillian, sotis I feel you are more like a politician than we are."
"I’m just a woman who doesn’t want to see those looks in the wards anymore," Lillian looked at the flag fluttering on the distant WHO building, "Health is a fundantal human right, and when technology is within reach, any barrier to its availability to those in need, whether legal, economic, or conceptual, deserves our full effort to dismantle."
"Sotis I increasingly feel our hypocrisy, and increasingly feel the sincerity of Easterners, Carl, forgive my bluntness, if K Therapy were an Arican technology, you probably wouldn’t be so-called careful, you’d definitely open a green light, so in fact, the obstacle to everything is not safety, safety is just a hypocritical excuse, the barrier is prejudice! Isn’t it?"
Lillian sneered.
Carl’s face instantly turned red; he had to admit that Lillian was right.
"It’s not like that... Lady Windsor!" Carl certainly wouldn’t admit it.
Lillian sneered again: "Lying has beco a habit for you, double standards have beco a habit, just like energy conservation and emission reduction, your so-called environntal protection is just a tool to suppress others, while the Chinese are truly doing this, sotis I hate ourselves, when did we beco like this, needing to rely on lies, prejudice, and closure to maintain our so-called threshold."
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