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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 215 drug applications between 29 April 2026 and 5 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 23 drug names.

2026/04/29 – 2026/05/05

Period
2026/04/29 to 2026/05/05, 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
215
Drugs with new generic filings (by drug name, de-duplicated)
23
Accepted this week, now under review
55

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

215filings, 27 of them generic

By application type

Application typeFilings
Supplement133
New drug33
Generic27
Import11
Unspecified6
Import re-registration4
Import (made outside China)1

By drug type

Drug typeFilings
TCM100
Chemical drug93
Therapeutic biologic20
Prophylactic biologic2

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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Celecoxib Tablets213
2Loxoprofen Sodium Patches2130
3Azilsartan Medoxomil Potassium Tablets2135
4Progesterone Soft Capsules212
5Pemafibrate Tablets1123
6Ebastine Oral Solution119
7利多卡因丙胺卡因气雾剂 · No verified English name115
8右美沙芬安非他酮缓释片 · No verified English name112
9地氟烷 · No verified English name111
10Dolutegravir Sodium Tablets113

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

138 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
2Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized750
3Qinghai Sheng Tong Tian He Zang Yao Pharmaceutical Co., Ltd. romanized660
4Sichuan Heng Rui Pharmaceutical Co., Ltd. romanized430
5Shenzhen Xin Li Tai Pharma Co., Ltd. romanized420
6F. Hoffmann-La Roche Ltd410
7Ipsen Pharma410
8Changchun Jin Sai Pharma Co., Ltd. romanized410
9Yunnan Tong Da Bio Pharma Co., Ltd. romanized330
10Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized330

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

48 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

18 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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