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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 455 drug applications between 8 April 2026 and 14 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 65 drug names.

2026/04/08 – 2026/04/14

Period
2026/04/08 to 2026/04/14, 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
455
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
130

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

455filings, 91 of them generic

By application type

Application typeFilings
Supplement254
Generic91
New drug60
Import30
Import re-registration13
Unspecified7

By drug type

Drug typeFilings
Chemical drug238
TCM140
Therapeutic biologic70
Biologic4
Prophylactic 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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1奥氮平萨米多芬片 · No verified English name410
2Ibuprofen Suspension3214
3Diclofenac Diethylamine Emulgel3120
4Ambroxol Hydrochloride Solution For Inhalation3110
5Topiramate Extended-release Capsules310
6Edaravone and Dexborneol Concentrated Solution for Injection2234
7Crisaborole Ointment2226
8盐酸毛果芸香碱滴眼液 · No verified English name225
9Bromhexine Hydrochloride Solution For Inhalation211
10Vonoprazan Fumarate Tablets2160

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

252 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Wan Sui Pharma Co., Ltd. romanized11100
2Novo Nordisk A/S1030
3Ha Yao Group Bio Gong Cheng Co., Ltd. romanized860
4Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized740
5Merck Sharp & Dohme B.V.620
6Li Lai Suzhou Pharmaceutical Co., Ltd. romanized620
7Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized610
8Jiangxi Ke Rui Pharma Co., Ltd. romanized530
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized530
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized520

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

129 this week

AcceptedDrugApplicants
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600114 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600113 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Import · Class 1 Admilparant片 · No verified English nameJXHL2600112 Bristol-Myers Squibb Company; Bristol-Myers Squibb(China)Investment Co. Ltd
2026/04/14Generic · Class 3 Fenofibrate TabletsCYHS2600859 You Hui Pharma (Beijing) Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2026/04/14Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2600858 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2026/04/14Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2600857 Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized
2026/04/14Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2600856 Hubei Tai Zi Pharma Co., Ltd. romanized
2026/04/14Generic · Class 3 尿素[13C]片呼气试验药盒 · No verified English nameCYHS2600854 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/04/14New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2600065 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2026/04/14New drug · Class 1 QT-019C细胞注射液 · No verified English nameCXSL2600405 Hangzhou Qi Han Bio Technology Co., Ltd. romanized
2026/04/14New drug · Class 1 重组人源化抗白介素-6受体单克隆抗体注射液 · No verified English nameCXSL2600404 Beijing Wei De Jie Bio Technology Co., Ltd. romanized
2026/04/14New drug · Class 1 ART105注射液 · No verified English nameCXHL2600436 Suzhou Ang Tuo Biopharmaceuticals Co., Ltd. romanized
2026/04/14New drug · Class 1 注射用TRD209 · No verified English nameCXHL2600435 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2026/04/13Import · Class 2.4 塞伐艾替尼片 · No verified English nameJXHS2600038 Bayer HealthCare Pharmaceuticals Inc.; Bayer AG; Bayer Healthcare Company Ltd.
2026/04/13Import · Class 2.4 Trientine Hydrochloride TabletsJXHL2600111 Orphalan SA; Fortrea Pharmaceutical Research and Development (Beijing) Co. Ltd.
2026/04/13Import · Class 2.4 英克司兰钠注射液 · No verified English nameJXHL2600110 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/04/13Generic · Class 3 Amifampridine phosphate tabletsCYHS2600850 Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized
2026/04/13Generic · Class 3 Furosemide Oral SolutionCYHS2600849 Da Wei (Anhui) Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/04/13Generic · Class 3 Ketorolac Trometamol TabletsCYHS2600848 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized
2026/04/13Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2600053 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/13Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2600052 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/13Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2600051 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/13Generic · Class 3 奥氮平萨米多芬片 · No verified English nameCYHL2600050 Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/13Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2600049 Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized
2026/04/13Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2600048 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/04/13Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2600047 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/04/13Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2600046 Sichuan Pu Rui Te Pharma Co., Ltd. romanized
2026/04/13New drug · Class 1.1 天精泽兰颗粒 · No verified English nameCXZL2600035 Lei Yun Shang Pharma Group Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized
2026/04/13New drug · Class 2.2 注射用泽尼达妥单抗 · No verified English nameCXSS2600064 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized
2026/04/13New drug · Class 1 STX11101注射液 · No verified English nameCXSL2600403 Shanghai Si De Ke Suo Bio Technology Co., Ltd. romanized

99 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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