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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 413 drug applications between 6 May 2024 and 12 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 86 drug names.

2024/05/06 – 2024/05/12

Period
2024/05/06 to 2024/05/12, 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
413
Drugs with new generic filings (by drug name, de-duplicated)
86
Accepted this week, now under review
0

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

413filings, 116 of them generic

By application type

Application typeFilings
Supplement177
Generic116
New drug77
Import25
Import re-registration13
Unspecified5

By drug type

Drug typeFilings
Chemical drug287
TCM62
Therapeutic biologic62
Prophylactic 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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Benidipine Hydrochloride Tablets324
3Fluvoxamine Maleate Tablets320
4Telmisartan Tablets314
5Sildenafil Citrate Tablets3112
6Deutetrabenazine Tablets310
7Nicorandil for Injection311
8聚乙二醇钠钾散 · No verified English name223
9Lactulose Oral Solution2134
10二甲硅油乳剂 · No verified English name2114

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

239 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized19170
2Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized1020
3Hubei Di Liu Pharmaceutical Co., Ltd. romanized750
4Janssen Research & Development LLC730
5Chongqing Sai Wei Pharma Co., Ltd. romanized722
6Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized656
7Bai Ao Tai Biopharmaceutical Co., Ltd. romanized630
8Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.623
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized620
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized620

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

141 this week

AcceptedDrugApplicants
2024/05/12Import · Class 2.2 马昔腾坦分散片 · No verified English nameJXHL2400107 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2024/05/12Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2401431 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2024/05/12New drug · Class 1 塔戈利单抗注射液 · No verified English nameCXSS2400049 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/05/12New drug · Class 1 CM512注射液 · No verified English nameCXSL2400309 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/05/12New drug · Class 1 重组I型单纯疱疹病毒R130注射液(Vero细胞) · No verified English nameCXSL2400308 Shanghai Yun Ying Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/12New drug · Class 2.4 Sufentanil Citrate InjectionCXHL2400470 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/12New drug · Class 2.4 Sufentanil Citrate InjectionCXHL2400469 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/12New drug · Class 2.4 Sufentanil Citrate InjectionCXHL2400468 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/12New drug · Class 2.4 Sufentanil Citrate InjectionCXHL2400467 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/12New drug · Class 2.4 Sufentanil Citrate InjectionCXHL2400466 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2024/05/12New drug · Class 1 HRS-4508片 · No verified English nameCXHL2400465 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/12New drug · Class 1 HRS-4508片 · No verified English nameCXHL2400464 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2400091 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2400090 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2400089 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/05/11Import · Class 2.2; 2.4 盐酸氨酮戊酸己酯软膏光动力治疗系统 · No verified English nameJXHS2400035 ASIERIS MEDITECH (Hong Kong) CO. LIMITED; Bioglan AB; Jiangsu Yahong Meditech Co. Ltd.
2024/05/11Import · Class 1 BI 690517片 · No verified English nameJXHL2400106 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/05/11Generic · Class 3 Doxycycline Hyclate TabletsCYHS2401422 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/11Generic · Class 3 Doxycycline Hyclate TabletsCYHS2401421 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/11Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2401419 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/05/11Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2401416 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/05/11Generic · Class 3 Nicorandil for InjectionCYHS2401411 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2024/05/11Generic · Class 3 Nicorandil for InjectionCYHS2401410 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2024/05/11Generic · Class 3 Nicorandil for InjectionCYHS2401409 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2024/05/11Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2401405 Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/05/11Generic · Class 3 Enalapril Maleate Oral SolutionCYHS2401404 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2024/05/11Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400089 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized
2024/05/11New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2400307 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/05/11New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2400306 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/11New drug · Class 1 RC148注射液 · No verified English nameCXSL2400305 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized

111 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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