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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 14 June 2026 and 20 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 42 drug names.

2026/06/14 – 2026/06/20

Period
2026/06/14 to 2026/06/20, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
104

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

359filings, 55 of them generic

By application type

Application typeFilings
Supplement211
New drug57
Generic55
Import18
Import re-registration11
Unspecified7

By drug type

Drug typeFilings
Chemical drug172
TCM125
Therapeutic biologic54
Prophylactic biologic5
Biologic3

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

42 drugs with new generic filings; top 10 listed

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Mei Hua Yi (Hebei) Pharmaceutical Co., Ltd. romanized990
2Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized980
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
4Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized880
5Pfizer Inc.630
6Zhejiang Wo Wu Bio Technology Co., Ltd. romanized510
7Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized440
8Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized440
9Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized420
10Bristol-Myers Squibb Pharma EEIG410

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

103 this week

AcceptedDrugApplicants
2026/06/18Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600146 Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd.
2026/06/18Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601456 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized
2026/06/18Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601455 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Jin Sheng Pharmaceutical Co., Ltd. romanized
2026/06/18Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2601452 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2026/06/18Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2601451 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2026/06/18Generic · Class 3 对乙酰氨基酚甘露醇注射液 · No verified English nameCYHS2601450 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Dong Guan Shi Pu Ji Pharma Co., Ltd. romanized
2026/06/18Generic · Class 3 Propranolol hydrochloride oral solutionCYHS2601449 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2026/06/18Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2601448 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized
2026/06/18New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600657 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/06/18New drug · Class 1 HEC-921注射液 · No verified English nameCXSL2600656 Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2026/06/18New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600742 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/06/18New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600741 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/06/18New drug · Class 2.3 TSL2402片 · No verified English nameCXHL2600740 Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized; Zhongguo Yao Ke University romanized
2026/06/17Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2600145 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/06/17Import · Class 1 HDP-101 · No verified English nameJXSL2600144 Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd.
2026/06/17Import · Class 1 ASP2138注射液 · No verified English nameJXSL2600143 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/06/17Generic · Class 3 Succinylcholine Chloride InjectionCYHS2601444 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601443 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2026/06/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601442 Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized
2026/06/17Generic · Class 3 Hydrotalcite SuspensionCYHS2601441 Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Methotrexate TabletsCYHS2601436 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601435 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2601434 Wuhan Ren Fu Pharma Co., Ltd. romanized; Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Ferrous Succinate TabletsCYHS2601433 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized
2026/06/17Generic · Class 3 富马酸氯马斯汀口服溶液 · No verified English nameCYHS2601431 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Potassium Chloride Oral SolutionCYHS2601430 Chongqing Xi Er An Pharma Co., Ltd. romanized; Chongqing Guo Tai Kang Ning Pharmaceutical Co., Ltd. romanized
2026/06/17Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2600073 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/06/17Generic · Class 3 贝派度酸依折麦布片 · No verified English nameCYHL2600072 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2026/06/17New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2600095 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2026/06/17New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2600094 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized

73 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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