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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 430 drug applications between 25 April 2026 and 1 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 51 drug names.

2026/04/25 – 2026/05/01

Period
2026/04/25 to 2026/05/01, 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
430
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
113

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

430filings, 63 of them generic

By application type

Application typeFilings
Supplement258
Generic63
New drug58
Import32
Import re-registration10
Unspecified8
Import (made outside China)1

By drug type

Drug typeFilings
Chemical drug197
TCM178
Therapeutic biologic49
Prophylactic biologic5
Biologic1

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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches4230
2Pemafibrate Tablets2223
3Celecoxib Tablets213
4Levetiracetam Tablets216
5左奥硝唑氯化钠注射液 · No verified English name215
6Lidocaine Hydrochloride Gel218
7Azilsartan Medoxomil Potassium Tablets2135
8Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)213
9醋酸去氨加压素片 · No verified English name216
10Progesterone Soft Capsules212

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

255 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized20130
2AstraZeneca AB1720
3Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized880
4Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized770
5Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized750
6Qinghai Sheng Tong Tian He Zang Yao Pharmaceutical Co., Ltd. romanized660
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD650
8Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized550
9F. Hoffmann-La Roche Ltd520
10Changchun Jin Sai Pharma 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

102 this week

AcceptedDrugApplicants
2026/05/01New drug · Class 1.1 天心解郁颗粒 · No verified English nameCXZL2600039 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/01New drug · Class 5.1 多西他赛注射液(白蛋白稳定型) · No verified English nameCXHS2600061 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized; Jian Jin Pharmaceutical Co., Ltd. romanized
2026/05/01New drug · Class 2.2 醋酸奥曲肽片 · No verified English nameCXHL2600525 San Die Ji (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/05/01New drug · Class 2.2 GCF20216 · No verified English nameCXHL2600523 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2026/04/30Import · Class 1 BAY 2433334片 · No verified English nameJXHS2600043 Bayer AG; Bayer Healthcare Company Ltd.
2026/04/30Import · Class 2.4 盐酸阿曲生坦片 · No verified English nameJXHL2600139 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/04/30Generic · Class 3 Ebastine Oral SolutionCYHS2601012 Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized
2026/04/30Generic · Class 3 Celecoxib TabletsCYHS2601011 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized
2026/04/30Generic · Class 3 Celecoxib TabletsCYHS2601010 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhong Tong Pharma Co., Ltd. romanized
2026/04/30Generic · Class 3 右美沙芬安非他酮缓释片 · No verified English nameCYHS2601007 Jiangsu En Hua Pharma Co., Ltd. romanized
2026/04/30Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2601006 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
2026/04/30Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2601004 Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized
2026/04/30New drug · Class 1 万基奥仑赛注射液 · No verified English nameCXSS2600077 Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2026/04/30New drug · Class 1 乐德奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600076 Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2026/04/30New drug · Class 1 乐德奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600075 Xian Sheng Pharma Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2026/04/30New drug · Class 1 注射用培重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2600074 Hangzhou Cheng Si Biopharmaceutical Co., Ltd. romanized; Cheng Si (Shanghai) Biopharmaceutical Co., Ltd. romanized
2026/04/30New drug · Class 1 注射用培重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2600073 Hangzhou Cheng Si Biopharmaceutical Co., Ltd. romanized; Cheng Si (Shanghai) Biopharmaceutical Co., Ltd. romanized
2026/04/30New drug · Class 1 SKB118注射液 · No verified English nameCXSL2600463 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/04/30New drug · Class 1.4 重组四价肠道病毒疫苗(汉逊酵母) · No verified English nameCXSL2600457 Wei Er Tai Ke (Beijing) Bio Technology Co., Ltd. romanized
2026/04/30New drug · Class 1 BW-41012注射液 · No verified English nameCXHL2600524 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2026/04/30New drug · Class 1 GLR2038片 · No verified English nameCXHL2600522 Gan Li Pharma Co., Ltd. romanized
2026/04/30New drug · Class 1 GLR2038片 · No verified English nameCXHL2600521 Gan Li Pharma Co., Ltd. romanized
2026/04/30New drug · Class 2.2 DYTH203 · No verified English nameCXHL2600520 Shanxi De Yuan Tang Pharma Co., Ltd. romanized
2026/04/30New drug · Class 1 SAL0167片 · No verified English nameCXHL2600519 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/04/30New drug · Class 1 SAL0167片 · No verified English nameCXHL2600518 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/04/30New drug · Class 1 SAL0167片 · No verified English nameCXHL2600517 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/04/29Import · Class 1 RO7435846片 · No verified English nameJXHL2600138 F. Hoffmann-La Roche Ltd
2026/04/29Import · Class 1 RO7435846片 · No verified English nameJXHL2600137 F. Hoffmann-La Roche Ltd
2026/04/29Import · Class 1 RO7435846片 · No verified English nameJXHL2600136 F. Hoffmann-La Roche Ltd
2026/04/29Import · Class 1 RO7435846片 · No verified English nameJXHL2600135 F. Hoffmann-La Roche Ltd

72 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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