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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 340 drug applications between 25 May 2026 and 31 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 19 drug names.

2026/05/25 – 2026/05/31

Period
2026/05/25 to 2026/05/31, 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
340
Drugs with new generic filings (by drug name, de-duplicated)
19
Accepted this week, now under review
50

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

340filings, 27 of them generic

By application type

Application typeFilings
Supplement238
New drug46
Generic27
Import17
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
TCM144
Chemical drug139
Therapeutic biologic47
Biologic5
Prophylactic biologic5

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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection510
2瑞维那新吸入溶液 · No verified English name2253
3口服溶液用盐酸万古霉素 · No verified English name212
4Milnacipran Hydrochloride Tablets218
5Ketorolac Tromethamine Injection214
6二硫化硒洗剂 · No verified English name1114
7Linaclotide Capsules1113
8吸入用布地奈德混悬液 · No verified English name117
9Dexamethasone Sodium Phosphate Injection115
10Bumetanide Injection1113

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized1190
2Changsha Dong Feng Pharma Co., Ltd. romanized660
3Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized550
4Jin Yao Da Ren Tang Group Co., Ltd. Le Ren Tang Pharmaceutical Factory romanized550
5Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
7Yi Chang Ren Fu Pharma Co., Ltd. romanized515
8Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized440
9Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized440
10Kyowa Kirin Co. Ltd.420

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

80 this week

AcceptedDrugApplicants
2026/05/29Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSS2600043 Roche Registration GmbH; Roche Diagnostics GmbH; F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2026/05/29Import · Class 1 INCA33890注射液 · No verified English nameJXSL2600123 Incyte Corporation; Incyte Biosciences (Shanghai) Co. Ltd.
2026/05/29Import · Class 1 Ponsegromab注射液 · No verified English nameJXSL2600122 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2026/05/29Import · Class 1 Imzokitug注射液 · No verified English nameJXSL2600121 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/29Import · Class 2.4 瑞米布替尼片 · No verified English nameJXHL2600192 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/05/29Import · Class 1 ASP3082注射液 · No verified English nameJXHL2600191 Astellas Pharma Global Development Inc.; Astellas (Beijing) Pharmaceutical R&D Co. Ltd.
2026/05/29Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2601213 Yun Peng Pharmaceuticals Group Co., Ltd. romanized
2026/05/29Generic · Class 3 Bumetanide InjectionCYHS2601212 Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2026/05/29Generic · Class 3 阿托伐他汀钙口服混悬液 · No verified English nameCYHS2601211 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/05/29Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2601210 Hong Jian Pharmaceutical (Shanghai) Co., Ltd. romanized; Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized
2026/05/29New drug · Class 1.1 复方内鲁帕尔颗粒 · No verified English nameCXZL2600049 He Tian Wei Wu Er Pharma Co., Ltd. romanized
2026/05/29New drug · Class 1 莱康奇塔单抗注射液(皮下注射) · No verified English nameCXSS2600087 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/05/29New drug · Class 1 脐带间充质干细胞注射液 · No verified English nameCXSL2600585 Shandong Bai Hong Gan Xi Bao Bio Technology Co., Ltd. romanized; Guangdong Bai Hong Gan Xi Bao Zai Sheng Yi Xue Co., Ltd. romanized
2026/05/29New drug · Class 1 注射用BL-M14D1 · No verified English nameCXSL2600584 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2026/05/29New drug · Class 1 注射用SKB571 · No verified English nameCXSL2600583 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/29New drug · Class 1 人源肠道菌群胶囊 · No verified English nameCXSL2600582 Xiamen Cheng Ge Bio Technology Co., Ltd. romanized
2026/05/29New drug · Class 1 注射用GB268 · No verified English nameCXSL2600581 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/05/29New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600580 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/05/29New drug · Class 2.2; 2.3 KL1110L干混悬剂 · No verified English nameCXHL2600638 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2026/05/29New drug · Class 2.2; 2.3 KL1110L干混悬剂 · No verified English nameCXHL2600637 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2026/05/29New drug · Class 1 LT010涂剂 · No verified English nameCXHL2600636 Chengdu Ling Tai Ke Bio Technology Co., Ltd. romanized
2026/05/29New drug · Class 1 LT010涂剂 · No verified English nameCXHL2600635 Chengdu Ling Tai Ke Bio Technology Co., Ltd. romanized
2026/05/29New drug · Class 2.4 BCM758 · No verified English nameCXHL2600634 Hangzhou He Li Xin Jian Biopharmaceuticals (Group) Co., Ltd. romanized
2026/05/29New drug · Class 1 HRS-4508片 · No verified English nameCXHL2600633 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/29New drug · Class 1 HRS-6209胶囊 · No verified English nameCXHL2600632 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/28Import · Class 2.4 甲磺酸亮丙瑞林注射液(6M) · No verified English nameJXHS2600057 Accord BioPharma Inc.; Fareva Pau; Changchun GeneScience Pharmaceuticals Co. Ltd.
2026/05/28Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2601208 Hubei Ke Tian Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601207 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/05/28Generic · Class 3 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601206 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600068 Yi Chang Ren Fu Pharma Co., Ltd. romanized

50 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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