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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 357 drug applications between 22 March 2026 and 28 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 47, covering 39 drug names.

2026/03/22 – 2026/03/28

Period
2026/03/22 to 2026/03/28, 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
357
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
77

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

357filings, 47 of them generic

By application type

Application typeFilings
Supplement225
New drug54
Generic47
Import11
Import re-registration11
Unspecified9

By drug type

Drug typeFilings
Chemical drug190
TCM140
Therapeutic biologic24
Biologic2
Prophylactic 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

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
3培美曲塞二钠注射液 · No verified English name212
4头孢地尼颗粒 · No verified English name213
5Cefditoren Pivoxil Granules2118
6Baricitinib Tablets2132
7Mirogabalin Besilate Tablets2161
8Ethyl Iosapentate Capsules1127
9Pemafibrate Tablets1123
10Crizotinib Capsules117

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

217 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
3Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized880
4Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized660
5Jiangxi Xin Zheng Pharma Co., Ltd. romanized550
6Takeda Development Center Americas Inc.510
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
8AstraZeneca AB430
9Eli Lilly and Company410
10Sanofi Winthrop Industrie410

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

77 this week

AcceptedDrugApplicants
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.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600093 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600092 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Import · Class 1 Brenipatide注射液 · No verified English nameJXHL2600091 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/27Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2600731 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/03/27Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2600729 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/03/27New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600352 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 RGT-490片 · No verified English nameCXHL2600387 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/03/27New drug · Class 1 RGT-490片 · No verified English nameCXHL2600386 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/03/27New drug · Class 1 TJ0113胶囊 · No verified English nameCXHL2600383 Hangzhou Tian Ji Ji Shi Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 INV-6452片 · No verified English nameCXHL2600382 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 INV-6452片 · No verified English nameCXHL2600381 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized
2026/03/27New drug · Class 1 拉尼兰诺片 · No verified English nameCXHL2600380 Zheng Da Tian Qing (Guangzhou) Pharmaceuticals Co., Ltd. romanized

47 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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