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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 436 drug applications between 4 July 2025 and 10 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 78 drug names.

2025/07/04 – 2025/07/10

Period
2025/07/04 to 2025/07/10, 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
436
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
90

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

436filings, 109 of them generic

By application type

Application typeFilings
Supplement200
Generic109
New drug88
Import29
Import re-registration8
Unspecified2

By drug type

Drug typeFilings
Chemical drug302
Therapeutic biologic69
TCM62
Prophylactic biologic2
Biologic1

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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1瑞维那新吸入溶液 · No verified English name5553
2Empagliflozin Tablets4218
3Dapoxetine Hydrochloride Tablets4220
4Quetiapine Fumarate Extended-release Tablets410
5Acyclovir Tablets316
6Pregabalin Oral Solution225
7Iguratimod Tablets2223
8醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English name222
9Finerenone Tablets2269
10依伏卡塞片 · No verified English name219

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

263 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized17140
2Eli Lilly and Company1030
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized860
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized660
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized630
6Celgene Corporation610
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized610
8Topfond Pharmaceutical Co., Ltd.550
9Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
10Karuna Therapeutics Inc.510

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

145 this week

AcceptedDrugApplicants
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500174 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500173 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500172 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500171 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500170 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Import · Class 1 Orforglipron片 · No verified English nameJXHL2500169 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/07/10Generic · Class 3 Trimebutine Maleate TabletsCYHS2502462 Ping Guang Pharmaceutical Co., Ltd. romanized
2025/07/10Generic · Class 3 Trimebutine Maleate TabletsCYHS2502461 Ping Guang Pharmaceutical Co., Ltd. romanized
2025/07/10Generic · Class 3 Terlipressin Acetate InjectionCYHS2502457 Wuhan Ren Fu Pharma Co., Ltd. romanized
2025/07/10Generic · Class 3 醋酸钠林格葡萄糖注射液(Ⅰ) · No verified English nameCYHS2502456 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2025/07/10Generic · Class 3 Esflurbiprofen PatchesCYHL2500125 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2025/07/10New drug · Class 3.1 半夏白术天麻颗粒 · No verified English nameCXZS2500028 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2025/07/10New drug · Class 3.1 真武颗粒 · No verified English nameCXZS2500027 Wuhan Kang Le Pharma Co., Ltd. romanized
2025/07/10New drug · Class 1 DCTY0801注射液 · No verified English nameCXSL2500568 Beijing Ding Cheng Tai Yuan Bio Technology Co., Ltd. romanized
2025/07/10New drug · Class 1 BGM0504片 · No verified English nameCXHL2500681 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2025/07/10New drug · Class 1 BGM0504片 · No verified English nameCXHL2500680 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2025/07/10New drug · Class 1 BGM0504片 · No verified English nameCXHL2500679 Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2025/07/10New drug · Class 2.2 EP-0206SI · No verified English nameCXHL2500670 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2025/07/10New drug · Class 2.2 EP-0206SI · No verified English nameCXHL2500669 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2025/07/10New drug · Class 1 SGB-3383注射液 · No verified English nameCXHL2500667 Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500168 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500167 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500166 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500165 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500164 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Import · Class 1 Mezigdomide胶囊 · No verified English nameJXHL2500163 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/07/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2502453 Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/07/09Generic · Class 3 Pregabalin Oral SolutionCYHS2502452 Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2025/07/09Generic · Class 3 Loxoprofen sodium hydrate gelCYHS2502451 Shanghai Yan An Pharmaceuticals Yang Pu Co., Ltd. romanized; Shanghai Yan An Pharma (Hubei) Co., Ltd. romanized
2025/07/09Generic · Class 3 硝酸咪康唑乳膏 · No verified English nameCYHS2502449 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized

115 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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