YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 383 drug applications between 16 June 2026 and 22 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.

2026/06/16 – 2026/06/22

Period
2026/06/16 to 2026/06/22, 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
383
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
101

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

383filings, 49 of them generic

By application type

Application typeFilings
Supplement236
New drug58
Generic49
Import20
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug168
TCM144
Therapeutic biologic62
Prophylactic biologic6
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

37 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

227 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Mei Hua Yi (Hebei) Pharmaceutical Co., Ltd. romanized990
2Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized880
3Novo Nordisk A/S820
4Heilongjiang Zhen Bao Dao Pharma Co., Ltd. romanized660
5Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized540
6Zhejiang Wo Wu Bio Technology Co., Ltd. romanized510
7Shanxi Hua Kang Pharma Co., Ltd. romanized440
8Shanxi Jin Xin Shuang He 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

104 this week

AcceptedDrugApplicants
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600071 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600070 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600069 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2600068 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2026/06/22Generic · Class 3 Acetylcysteine TabletsCYHS2601460 Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized
2026/06/22Generic · Class 3 Doxycycline Hyclate TabletsCYHS2601459 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/06/22New drug · Class 3.1 清金化痰汤颗粒 · No verified English nameCXZS2600032 Hunan Jiudian Pharmaceutical Co., Ltd
2026/06/22New drug · Class 1 注射用LYNC-101 · No verified English nameCXSL2600660 Ling Tai Tian Run Bio Technology (Shanghai) Co., Ltd. romanized
2026/06/22New drug · Class 1 TVAX-008注射液 · No verified English nameCXSL2600659 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2026/06/22New drug · Class 1.2 新型流感病毒mRNA疫苗 · No verified English nameCXSL2600658 Hua Lan Bio Yi Miao Co., Ltd. romanized
2026/06/22New drug · Class 1 MT2004胶囊 · No verified English nameCXHL2600745 Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/06/22New drug · Class 1 MT2004胶囊 · No verified English nameCXHL2600744 Xian Ao Li Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/06/22New drug · Class 1 AHB-137注射液 · No verified English nameCXHL2600743 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
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

74 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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