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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 15 November 2025 and 21 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.

2025/11/15 – 2025/11/21

Period
2025/11/15 to 2025/11/21, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
80

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

309filings, 68 of them generic

By application type

Application typeFilings
Supplement149
Generic68
New drug62
Unspecified12
Import re-registration10
Import8

By drug type

Drug typeFilings
Chemical drug174
TCM74
Therapeutic biologic46
Biologic10
Prophylactic biologic5

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

52 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 name2114
4Furosemide Oral Solution218
5Ibuprofen Granules213
6Tolvaptan Orally Disintegrating Tablets215
7Sildenafil Citrate Tablets2112
8氯雷他定糖浆 · No verified English name217
9Sacubitril Valsartan Sodium Tablets2170
10注射用青霉素钠/氯化钠注射液 · 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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1410
2Qinghai Jiu Mei Cang Pharmaceuticals Technology Co., Ltd. romanized880
3Qilu Pharmaceutical Co., Ltd.761
4Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized754
5Hunan Ke Lun Pharmaceutical Co., Ltd. romanized522
6Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized510
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
8Terumo Corporation Kofu Factory410
9Yi Chang Ren Fu Pharma Co., Ltd. romanized414
10Hangzhou Jing Yao Bio Technology 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

97 this week

AcceptedDrugApplicants
2025/11/21Generic · Class 3 Amifostine For InjectionCYHS2504020 Da Lian Mei Luo Zhong Pharmaceutical Factory Co., Ltd. romanized; Mei Luo Pharma Co., Ltd. romanized
2025/11/21New drug · Class 2.3 湿润烧伤膏 · No verified English nameCXZL2500117 Shan Tou Shi Mei Bao Pharmaceutical Co., Ltd. romanized
2025/11/21New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSS2500124 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2025/11/21New drug · Class 1 注射用SKB518 · No verified English nameCXSL2500997 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2025/11/21New drug · Class 1 注射用HLX43 · No verified English nameCXSL2500996 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/11/21New drug · Class 1 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2500995 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/11/21New drug · Class 1 注射用JSKN003 · No verified English nameCXSL2500994 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/11/21New drug · Class 1 QLP2117注射液 · No verified English nameCXSL2500993 Qilu Pharmaceutical Co., Ltd.
2025/11/21New drug · Class 2.2 QL2107注射液 · No verified English nameCXSL2500992 Qilu Pharmaceutical Co., Ltd.
2025/11/21New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2500991 Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2025/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2500138 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/11/21New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2500137 Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2025/11/21New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2501287 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2025/11/21New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2501286 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2025/11/21New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2501285 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
2025/11/21New drug · Class 1 BPI-572270胶囊 · No verified English nameCXHL2501284 Hangzhou Jing Yao Bio Technology Co., Ltd. romanized
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

67 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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