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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 305 drug applications between 14 November 2025 and 20 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 49 drug names.

2025/11/14 – 2025/11/20

Period
2025/11/14 to 2025/11/20, 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
305
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
75

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

305filings, 68 of them generic

By application type

Application typeFilings
Supplement142
Generic68
New drug64
Import13
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug180
TCM78
Therapeutic biologic34
Prophylactic biologic7
Biologic6

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lisdexamfetamine Dimesylate capsules414
2Polyvinyl Alcohol Eye Drops3324
3二甲硅油乳剂 · No verified English name3214
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution3223
5MOVICOL Ready To Take Sachet, Powder For Oral Solution2216
6依伏卡塞片 · No verified English name219
7Furosemide Oral Solution218
8Ibuprofen Granules213
9Tolvaptan Orally Disintegrating Tablets215
10氯雷他定糖浆 · No verified English name217

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

194 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1410
2Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized880
3Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized550
4Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized542
5Qilu Pharmaceutical Co., Ltd.541
6Hunan Ke Lun Pharmaceutical Co., Ltd. romanized522
7Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
8Eli Lilly and Company430
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
10Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized410

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
2025/11/20Import · Class 1 AMO959硬胶囊 · No verified English nameJXHL2500359 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/20Import · Class 2.4 镥(177Lu)vipivotide tetraxetan注射液 · No verified English nameJXHL2500358 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/20Import · Class 1 AMO959硬胶囊 · No verified English nameJXHL2500357 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/11/20Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2504012 Zhong Shan Ke Ke Kang Pharmaceutical Co., Ltd. romanized
2025/11/20New drug · Class 1 SHR-1894注射液 · No verified English nameCXSL2500990 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/11/20New drug · Class 1 EHT102注射液 · No verified English nameCXSL2500989 Shanghai You Yin Pharmaceuticals Bio Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 SYS6010 · No verified English nameCXSL2500988 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/11/20New drug · Class 2.4 芦沃美替尼片 · No verified English nameCXHS2500140 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/11/20New drug · Class 2.4 芦沃美替尼片 · No verified English nameCXHS2500139 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/11/20New drug · Class 1 HSK42360-Na片 · No verified English nameCXHL2501283 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2025/11/20New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2501282 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2501281 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2501280 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 ASP3082注射液 · No verified English nameCXHL2501279 An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized
2025/11/20New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2501278 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2501277 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2501276 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2501275 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2025/11/20New drug · Class 1 RAY1225注射液 · No verified English nameCXHL2501274 Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized
2025/11/19Import · Class 1 盐酸伊可白滞素片 · No verified English nameJXHS2500133 Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Xian Janssen Pharmaceutical Ltd.
2025/11/19Generic · Class 3 利格列汀二甲双胍缓释片(I) · No verified English nameCYHS2504008 Jiangsu Deyuan Pharmaceutical Co.,Ltd.
2025/11/19Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2504007 TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504006 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2504005 TIANJIN LISHENG PHARMACEUTICAL CO., LTD; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504004 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504003 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2504002 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 Lisdexamfetamine Dimesylate capsulesCYHS2504001 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2025/11/19Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2504000 Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2025/11/19Generic · Class 3 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2503999 Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized

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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