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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 365 drug applications between 24 March 2026 and 30 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 39 drug names.

2026/03/24 – 2026/03/30

Period
2026/03/24 to 2026/03/30, 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
365
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
79

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

365filings, 48 of them generic

By application type

Application typeFilings
Supplement225
New drug61
Generic48
Import re-registration13
Unspecified10
Import8

By drug type

Drug typeFilings
Chemical drug190
TCM142
Therapeutic biologic29
Biologic2
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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets313
2Tacrolimus Sustained-release Capsules216
3Linagliptin and Metformin Hydrochloride Extended Release Tablets214
4培美曲塞二钠注射液 · No verified English name212
5头孢地尼颗粒 · No verified English name213
6Cefditoren Pivoxil Granules2118
7Baricitinib Tablets2132
8Mirogabalin Besilate Tablets2161
9Ethyl Iosapentate Capsules1127
10Pemafibrate Tablets1123

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized15130
2Yi Chun Kang Er Xin Pharma Co., Ltd. romanized11100
3Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
4Henan Nuo Mei Pharma Co., Ltd. romanized660
5Ha Yao Group Bio Gong Cheng Co., Ltd. romanized620
6Jiangxi Xin Zheng Pharma Co., Ltd. romanized550
7Takeda Development Center Americas Inc.510
8Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized440
9Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
10AstraZeneca AB430

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

81 this week

AcceptedDrugApplicants
2026/03/30Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2600746 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2026/03/30Generic · Class 3 Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2600745 Nan Tong Lian Ya Pharma Co., Ltd. romanized
2026/03/30New drug · Class 2.1 热毒宁颗粒 · No verified English nameCXZS2600018 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/03/30New drug · Class 1 注射用QLF4113 · No verified English nameCXSL2600363 Qilu Pharmaceutical Co., Ltd.
2026/03/30New drug · Class 1.2 猴痘mRNA疫苗 · No verified English nameCXSL2600362 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized
2026/03/30New drug · Class 1 注射用BL-M14D1 · No verified English nameCXSL2600361 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/03/30New drug · Class 1 IBI354 · No verified English nameCXSL2600360 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2026/03/30New drug · Class 1 ICP-B208 · No verified English nameCXSL2600359 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2026/03/30New drug · Class 1 ADRX-0405 · No verified English nameCXSL2600358 Shanghai De Feng Pharma Co., Ltd. romanized
2026/03/30New drug · Class 2.2; 2.4 DMET25001缓释片 · No verified English nameCXHL2600397 Wuhan Long Sheng Pharmaceuticals Technology Co., Ltd. romanized
2026/03/30New drug · Class 2.2; 2.4 DMET25001缓释片 · No verified English nameCXHL2600396 Wuhan Long Sheng Pharmaceuticals Technology Co., Ltd. romanized
2026/03/30New drug · Class 1 注射用WP1302 · No verified English nameCXHL2600395 Bai Ming Xin Kang Bio Technology (Zhejiang) Co., Ltd. romanized
2026/03/28Import · Class 1 AZD2936 · No verified English nameJXSL2600087 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/03/28Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2600737 Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/03/28New drug · Class 3.1 麦门冬汤颗粒 · No verified English nameCXZS2600017 Guangdong Yi Fang Pharmaceutical Co., Ltd. romanized
2026/03/28New drug · Class 1.1 香术调脾和中颗粒 · No verified English nameCXZL2600032 Shanxi Sheng Zhong Pharmaceuticals Research Institute (Shanxi Sheng Zhong Hospital) romanized
2026/03/28New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2600357 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2600356 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 GT201注射液 · No verified English nameCXSL2600355 Beijing Sha Li Biopharmaceuticals Co., Ltd. romanized
2026/03/28New drug · Class 1 SCTB10注射液 · No verified English nameCXSL2600354 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/03/28New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2600394 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 JYP0015片 · No verified English nameCXHL2600393 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 JYP0015片 · No verified English nameCXHL2600392 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2600391 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 JYP0015片 · No verified English nameCXHL2600390 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2600389 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2026/03/28New drug · Class 1 JYP0015片 · No verified English nameCXHL2600388 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2026/03/27Import · Class 2.2 阿伏利尤单抗注射液 · No verified English nameJXSL2600086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2026/03/27Import · Class 1 贝普若韦生注射液 · No verified English nameJXHS2600033 GlaxoSmithKline Trading Services Limited; GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS; GlaxoSmithKline (China) Investment Company Limited
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600094 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.

51 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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