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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 5 August 2024 and 11 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 76 drug names.

2024/08/05 – 2024/08/11

Period
2024/08/05 to 2024/08/11, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
1

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

370filings, 114 of them generic

By application type

Application typeFilings
Supplement157
Generic114
New drug51
Import19
Unspecified18
Import re-registration11

By drug type

Drug typeFilings
Chemical drug276
TCM44
Therapeutic biologic34
Biologic10
Prophylactic biologic6

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1生理氯化钠溶液 · No verified English name5117
2苯磺酸左氨氯地平片 · No verified English name4245
3Bisoprolol Fumarate and Amlodipine Besylate Tablets339
4氯化钙注射液 · No verified English name336
5Minoxidil Liniment3252
6Sacubitril Valsartan Sodium Tablets3170
7Cefoperazone Sodium and Sulbactam Sodium for Injection3114
8Metformin Hydrochloride Extended-release Tablets3110
9Pioglitazone and Metformin Hydrochloride Tablets2210
10Hydrotalcite Chewable Tablets226

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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1410
2Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized810
3Shenyang Hong Yao Group Co., Ltd. romanized770
4Novo Nordisk A/S730
5Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
6Hebei Dao En Pharma Co., Ltd. romanized515
7Shandong Qidu Pharmaceutical Co., Ltd.444
8Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized440
9Chengdu Brilliant Pharmaceutical Co., Ltd.433
10Qilu Pharmaceutical Co., Ltd.432

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

127 this week

AcceptedDrugApplicants
2024/08/10Import · Class 1 ALPN-303注射液 · No verified English nameJXSL2400147 Alpine Immune Sciences Inc.; Name not romanized
2024/08/10Generic · Class 3 Nimesulide TabletsCYHS2402594 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/08/10Generic · Class 3 Minoxidil LinimentCYHS2402593 Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized
2024/08/10Generic · Class 3 Minoxidil LinimentCYHS2402592 Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized
2024/08/10Generic · Class 3 吡格列酮二甲双胍片(15mg/850mg) · No verified English nameCYHS2402591 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/08/10Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2402588 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2024/08/10Generic · Class 3 Diprophylline InjectionCYHS2402586 Jiangxi Yi You Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/08/10Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402585 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/10New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSL2400532 Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized; Hua Lan Ji Yin Gong Cheng Co., Ltd. romanized
2024/08/10New drug · Class 1 HC022注射液 · No verified English nameCXSL2400531 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2024/08/10New drug · Class 3.3 精蛋白人胰岛素混合注射液 (30R) · No verified English nameCXSL2400530 Heng Jing He Chuang Biopharmaceuticals (Zhejiang) Co., Ltd. romanized
2024/08/10New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2400529 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/08/10New drug · Class 2.2 BIOS2210 · No verified English nameCXHL2400815 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/08/10New drug · Class 2.2 BIOS2210 · No verified English nameCXHL2400814 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/08/10New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400813 Shanxi Jia Yuan Biopharmaceuticals Co., Ltd. romanized
2024/08/10New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2400812 Shanxi Jia Yuan Biopharmaceuticals Co., Ltd. romanized
2024/08/10New drug · Class 2.2 BM2216缓释片 · No verified English nameCXHL2400811 Nanjing Bai Mai Bio Technology Co., Ltd. romanized
2024/08/10New drug · Class 2.2 BM2216缓释片 · No verified English nameCXHL2400810 Nanjing Bai Mai Bio Technology Co., Ltd. romanized
2024/08/10New drug · Class 2.2 BM2216缓释片 · No verified English nameCXHL2400809 Nanjing Bai Mai Bio Technology Co., Ltd. romanized
2024/08/09Import · Class 2.4 艾伏尼布片 · No verified English nameJXHL2400198 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/08/09Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2402578 Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/08/09Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402577 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/09Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402576 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/09Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2402575 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402574 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402573 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402572 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402571 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402570 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2402569 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Wei Kang Pharma Co., Ltd. romanized

97 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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