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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 307 drug applications between 5 June 2025 and 11 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 64 drug names.

2025/06/05 – 2025/06/11

Period
2025/06/05 to 2025/06/11, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
307
Drugs with new generic filings (by drug name, de-duplicated)
64
Accepted this week, now under review
50

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

307filings, 95 of them generic

By application type

Application typeFilings
Supplement125
Generic95
New drug60
Import17
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug205
TCM48
Therapeutic biologic48
Prophylactic biologic4
Biologic2

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

64 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection111053
2Sodium Nitroprusside Injection3215
3Brexpiprazole Tablets3131
4Paliperidone Palmitate Injection318
5Ethyl Iosapentate Capsules2227
6Bilastine Oral Solution228
7Glucosamine Sulfate Capsules2251
8Folic acid injection211
9Zoledronic Acid Injection212
10多种微量元素注射液(Ⅲ) · No verified English name212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qilu Pharmaceutical Co., Ltd.541
2Xian Da Heng Pharmaceutical Co., Ltd. romanized440
3Shandong Qidu Pharmaceutical Co., Ltd.433
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
5Jiangsu Hao Sen Pharma Group Co., Ltd. romanized420
6Eli Lilly Nederland B.V.410
7Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized330
8Zun Yi Hua Wei Pharmaceutical Co., Ltd. romanized330
9Merck Sharp & Dohme B.V.320
10Novartis Pharma AG320

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

107 this week

AcceptedDrugApplicants
2025/06/11Import · Class 3.1 Dostarlimab注射液 · No verified English nameJXSL2500087 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2025/06/11Import · Class 1 注射用MK-1022 · No verified English nameJXSL2500086 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/06/11Import · Class 1 BI 690517片 · No verified English nameJXHL2500132 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2025/06/11Generic · Class 3 Timolol Maleate Eye DropsCYHS2502062 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/06/11Generic · Class 3 Bilastine Oral SolutionCYHS2502060 Nanjing Huang Long Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2025/06/11Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2502055 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/06/11Generic · Class 3 中性腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2502052 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/06/11New drug · Class 3.4 甘精胰岛素利司那肽注射液(Ⅱ) · No verified English nameCXSS2500063 Sai Nuo Fei (Beijing) Pharmaceutical Co., Ltd. romanized
2025/06/11New drug · Class 3.4 甘精胰岛素利司那肽注射液(Ⅰ) · No verified English nameCXSS2500062 Sai Nuo Fei (Beijing) Pharmaceutical Co., Ltd. romanized
2025/06/11New drug · Class 1 CM536注射液 · No verified English nameCXSL2500474 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/06/11New drug · Class 2.2 SPIEC肠溶微片 · No verified English nameCXHL2500551 Jilin Tian Heng Pharma Co., Ltd. romanized
2025/06/10Import · Class 1 Muvalaplin片 · No verified English nameJXHL2500131 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/06/10Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502047 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502046 Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 Acetylcysteine InjectionCYHS2502043 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 Acetylcysteine InjectionCYHS2502042 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 布洛芬去氧肾上腺素片 · No verified English nameCYHS2502033 Kang Zhi Pharma Co., Ltd. romanized
2025/06/10Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2502032 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/06/10Generic · Class 3 Ciclosporin Eye Drops(Ⅱ)CYHL2500108 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 2.3 金振口服液 · No verified English nameCXZL2500038 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/06/10New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2500061 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized
2025/06/10New drug · Class 1 GR1802注射液 · No verified English nameCXSL2500470 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 1 GR1802注射液 · No verified English nameCXSL2500469 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/06/10New drug · Class 1.2 NT-INF-001制剂 · No verified English nameCXSL2500468 Jia Yi Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2025/06/10New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500467 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 注射用QLS31905 · No verified English nameCXSL2500466 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 HRS-6093片 · No verified English nameCXHL2500550 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/10New drug · Class 1 HRS-6093片 · No verified English nameCXHL2500549 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/06/10New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500548 Qilu Pharmaceutical Co., Ltd.
2025/06/10New drug · Class 1 QLH12016胶囊 · No verified English nameCXHL2500547 Qilu Pharmaceutical Co., Ltd.

77 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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