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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 353 drug applications between 25 March 2026 and 31 March 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 46, covering 35 drug names.

2026/03/25 – 2026/03/31

Period
2026/03/25 to 2026/03/31, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
353
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
78

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

353filings, 46 of them generic

By application type

Application typeFilings
Supplement218
New drug56
Generic46
Import re-registration13
Unspecified11
Import9

By drug type

Drug typeFilings
Chemical drug182
TCM142
Therapeutic biologic25
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

35 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
4Diclofenac Diethylamine Emulgel2120
5Cefditoren Pivoxil Granules2118
6Montelukast Sodium Chewable Tablets214
7Baricitinib Tablets2132
8Epinastine Hydrochloride Tablets212
9Labetalol Hydrochloride Tablets213
10Mirogabalin Besilate Tablets2161

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

215 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
3Ha Yao Group Bio Gong Cheng Co., Ltd. romanized930
4Henan Nuo Mei Pharma Co., Ltd. romanized660
5Takeda Development Center Americas Inc.510
6Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized440
7Shaanxi Pan Long Pharma Group Co., Ltd. romanized440
8Novartis Pharma Schweiz AG420
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

75 this week

AcceptedDrugApplicants
2026/03/31Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2600756 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2026/03/31Generic · Class 3 Labetalol Hydrochloride TabletsCYHS2600755 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2026/03/31Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2600754 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/03/31Generic · Class 3 Ebastine Oral SolutionCYHS2600749 Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized
2026/03/31New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600062 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/31New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSS2600061 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/31New drug · Class 1 BBT001注射液 · No verified English nameCXSL2600364 Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/31New drug · Class 1 ARD-489AD片 · No verified English nameCXHL2600402 Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized
2026/03/31New drug · Class 1 ARD-489AD片 · No verified English nameCXHL2600401 Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized
2026/03/31New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600400 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/31New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600399 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/31New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600398 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
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

45 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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