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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 420 drug applications between 14 May 2026 and 20 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 49 drug names.

2026/05/14 – 2026/05/20

Period
2026/05/14 to 2026/05/20, 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
420
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
108

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

420filings, 73 of them generic

By application type

Application typeFilings
Supplement242
New drug83
Generic73
Import re-registration13
Import5
Unspecified4

By drug type

Drug typeFilings
Chemical drug209
TCM142
Therapeutic biologic64
Biologic3
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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6270
2瑞维那新吸入溶液 · No verified English name3353
3Adapalene And Benzoyl Peroxide Gel3230
4Brexpiprazole Tablets3131
5LevomilnacipranHydrochloride Extended-release Capsules316
6二甲硅油乳剂 · No verified English name2114
7复方醋酸钠葡萄糖注射液 · No verified English name218
8Levofloxacin and Sodium Chloride Injection2114
9注射用托伐普坦磷酸钠 · No verified English name2115
10Procaterol Hydrochloride Oral Solution2112

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

241 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized32130
2Xian Da Tang Pharmaceutical Group Co., Ltd. romanized11110
3Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
5Kyowa Kirin Co. Ltd.610
6LABORATORIOS FARMACEUTICOS ROVI S. A.510
7Le Shi Tong Ren San Men Xia Pharmaceutical Co., Ltd. romanized440
8Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
9Hubei Dong Xin Pharma Co., Ltd. romanized440
10Gansu Tian Shui Qi Huang Pharma 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

106 this week

AcceptedDrugApplicants
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
2026/05/20New drug · Class 1 PG-040滴眼液 · No verified English nameCXHL2600599 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized
2026/05/19Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2601174 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2026/05/19Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2601173 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2026/05/19Generic · Class 3 注射用甲钴胺 · No verified English nameCYHL2600062 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/05/19New drug · Class 1 JMB2302注射液 · No verified English nameCXSL2600549 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 JMB2302注射液 · No verified English nameCXSL2600548 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 UGX202注射液 · No verified English nameCXSL2600547 Suzhou Xing Ming You Jian Bio Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 治疗用人乳头瘤病毒mRNA疫苗 · No verified English nameCXSL2600546 Rong Can Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/19New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2600545 Shanghai Jun Sai Bio Co., Ltd. romanized; Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600598 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600597 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600596 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600595 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600594 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600593 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600592 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 ISM8969/HT-001片 · No verified English nameCXHL2600591 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized; Shenzhen Heng Tai Bio Technology Co., Ltd. romanized

76 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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