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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 154 drug applications between 1 May 2026 and 7 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 12 drug names.

2026/05/01 – 2026/05/07

Period
2026/05/01 to 2026/05/07, 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
154
Drugs with new generic filings (by drug name, de-duplicated)
12
Accepted this week, now under review
30

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

154filings, 13 of them generic

By application type

Application typeFilings
Supplement108
New drug23
Generic13
Unspecified4
Import3
Import re-registration3

By drug type

Drug typeFilings
TCM82
Chemical drug50
Therapeutic biologic20
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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Atosiban Acetate Injection212
2Pemafibrate Tablets1123
3噻托溴铵吸入粉雾剂 · No verified English name112
4Menatetrenone Soft Capsules114
5Deferasirox Granules112
6Levofloxacin and Sodium Chloride Injection1114
7Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution1123
8Amphotericin B Liposome for Injection112
9Epirubicin Hydrochloride for Injection112
10Ambroxol Hydrochloride Tablets113

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

108 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
2Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized860
3Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized440
4Qilu Pharmaceutical Co., Ltd.410
5Haerbin Tong Yi Tang Pharma Co., Ltd. romanized330
6Pfizer Inc.320
7CKD Bio Corporation220
8Kashima Plant,Eisai Co. Ltd.220
9Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized220
10He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized220

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

26 this week

AcceptedDrugApplicants
2026/05/07Import · Class 1 注射用Dapirolizumab Pegol单抗 · No verified English nameJXSL2600108 UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd
2026/05/07New drug · Class 1 注射用重组抗EpCAM 和CD3人鼠嵌合双特异性抗体 · No verified English nameCXSS2600078 Zheng Da Tian Qing Run Xin Pharmaceuticals (Wuhan) Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 注射用HBM2001(皮下注射) · No verified English nameCXSL2600477 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/05/07New drug · Class 1 注射用HBM2001 · No verified English nameCXSL2600476 He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized
2026/05/07New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600471 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 注射用SHR-1501 · No verified English nameCXSL2600470 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 SHR-2005注射液 · No verified English nameCXSL2600469 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 注射用HLX43 · No verified English nameCXSL2600468 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 HLX37注射液 · No verified English nameCXSL2600467 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/05/07New drug · Class 1 TT-00973-MS片 · No verified English nameCXHL2600533 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2026/05/07New drug · Class 1 YC020滴眼液 · No verified English nameCXHL2600532 Beijing Yi Cheng Qi Ming Technology Co., Ltd. romanized
2026/05/07New drug · Class 2.2 CB549 · No verified English nameCXHL2600529 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized
2026/05/06Generic · Class 3 Deferasirox GranulesCYHS2601029 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/05/06Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601024 Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized
2026/05/06New drug · Class 1 KHN921注射液 · No verified English nameCXSL2600466 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2026/05/06New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSL2600465 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/06New drug · Class 2.2 注射用芦康沙妥珠单抗 · No verified English nameCXSL2600464 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2026/05/06New drug · Class 1 QLS1410片 · No verified English nameCXHL2600531 Qilu Pharmaceutical Co., Ltd.
2026/05/06New drug · Class 1 QLS1410片 · No verified English nameCXHL2600530 Qilu Pharmaceutical Co., Ltd.
2026/05/06New drug · Class 1 QLS1410片 · No verified English nameCXHL2600528 Qilu Pharmaceutical Co., Ltd.
2026/05/06New drug · Class 1 QLS1410片 · No verified English nameCXHL2600527 Qilu Pharmaceutical Co., Ltd.
2026/05/06New drug · Class 1 YF087片 · No verified English nameCXHL2600526 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2026/05/01New drug · Class 1.1 天心解郁颗粒 · No verified English nameCXZL2600039 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/01New drug · Class 5.1 多西他赛注射液(白蛋白稳定型) · No verified English nameCXHS2600061 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized; Jian Jin Pharmaceutical Co., Ltd. romanized
2026/05/01New drug · Class 2.2 醋酸奥曲肽片 · No verified English nameCXHL2600525 San Die Ji (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/05/01New drug · Class 2.2 GCF20216 · No verified English nameCXHL2600523 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized

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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