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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 300 drug applications between 15 May 2026 and 21 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.

2026/05/15 – 2026/05/21

Period
2026/05/15 to 2026/05/21, 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
300
Drugs with new generic filings (by drug name, de-duplicated)
24
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

300filings, 32 of them generic

By application type

Application typeFilings
Supplement182
New drug69
Generic32
Import re-registration9
Unspecified4
Import4

By drug type

Drug typeFilings
TCM135
Chemical drug107
Therapeutic biologic55
Biologic3

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

24 drugs with new generic filings; top 10 listed

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xian Da Tang Pharmaceutical Group Co., Ltd. romanized11110
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1050
3Tong Hua Jin Ma Pharma Group Co., Ltd. romanized870
4Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
6Hunan De Kang Pharmaceutical Co., Ltd. romanized550
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
8Hubei Dong Xin Pharma Co., Ltd. romanized440
9Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized440
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440

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
2026/05/21Import · Class 1 Belantamab (GSK2857914) 注射液 · No verified English nameJXSL2600119 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2026/05/21Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600118 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/05/21Import · Class 2.2 Nemolizumab注射液 · No verified English nameJXSL2600117 Galderma SA; Q-Med International Trading (Shanghai) Co. Ltd
2026/05/21New drug · Class 1.1 归柴止痛颗粒 · No verified English nameCXZL2600047 Shenzhen Shi Shuang Bai Kang Pharmaceuticals Technology Co., Ltd. romanized
2026/05/21New drug · Class 1.1 芪箭颗粒 · No verified English nameCXZL2600046 Kang Chen Pharma (Nei Menggu) Co., Ltd. romanized
2026/05/21New drug · Class 1 RY_SW01细胞注射液 · No verified English nameCXSS2600086 Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized
2026/05/21New drug · Class 1 注射用SKB565 · No verified English nameCXSL2600559 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/21New drug · Class 1 IPM514注射液 · No verified English nameCXSL2600558 Beijing Zhen Zhi Yi Xue Technology Co., Ltd. romanized
2026/05/21New drug · Class 1 SHR-7012注射液 · No verified English nameCXSL2600557 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/21New drug · Class 1 IF001注射液 · No verified English nameCXSL2600556 Yin Fan (Jinan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/21New drug · Class 2.2 BN025305H · No verified English nameCXHL2600612 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/05/21New drug · Class 2.2 BN025305H · No verified English nameCXHL2600611 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/05/21New drug · Class 1 YKYY033注射液 · No verified English nameCXHL2600610 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/05/21New drug · Class 2.1; 2.4 ICF001吸入粉雾剂 · No verified English nameCXHL2600609 Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized
2026/05/21New drug · Class 2.1; 2.4 ICF001吸入粉雾剂 · No verified English nameCXHL2600608 Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized
2026/05/21New drug · Class 2.1; 2.4 ICF001吸入粉雾剂 · No verified English nameCXHL2600607 Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized; Zhang Feng Pharma Co., Ltd. romanized
2026/05/21New drug · Class 1 STC009注射液 · No verified English nameCXHL2600606 Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized
2026/05/20Generic · Class 3 氨氯地平缬沙坦氢氯噻嗪片 · No verified English nameCYHL2600063 Jiangsu Yong An Pharmaceutical Co., Ltd. romanized
2026/05/20New drug · Class 1 iNK-1001注射液 · No verified English nameCXSL2600555 Shanghai Ai Sa Er Biopharmaceuticals Co., Ltd. romanized
2026/05/20New drug · Class 1 人脐带来源3D间充质干细胞注射液 · No verified English nameCXSL2600554 Sai Pu Bio Technology (Changchun) Co., Ltd. romanized
2026/05/20New drug · Class 1 注射用LM-302 · No verified English nameCXSL2600553 Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/05/20New drug · Class 1 CT1190B CAR T细胞注射液 · No verified English nameCXSL2600552 You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/05/20New drug · Class 1 SHR-7590注射液 · No verified English nameCXSL2600551 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/20New drug · Class 1 SHR-7590注射液 · No verified English nameCXSL2600550 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/20New drug · Class 1 SAL0195注射液 · No verified English nameCXHL2600605 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Shenzhen Shi Ge Bi Jia Fen Zi Drug Innovation Center Co., Ltd. romanized
2026/05/20New drug · Class 1 HW243040片 · No verified English nameCXHL2600604 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2026/05/20New drug · Class 1 HW243040片 · No verified English nameCXHL2600603 Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized
2026/05/20New drug · Class 1 PG-040滴眼液 · No verified English nameCXHL2600602 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2026/05/20New drug · Class 1 PG-040滴眼液 · No verified English nameCXHL2600601 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2026/05/20New drug · Class 1 PG-040滴眼液 · No verified English nameCXHL2600600 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized

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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