YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 134 drug applications between 2 May 2024 and 8 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 35 drug names.
2024/05/02 – 2024/05/08
- New acceptances this week
- 134
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 0
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
134filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 61 |
| Generic | 44 |
| New drug | 12 |
| Import | 9 |
| Import re-registration | 6 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 97 |
| TCM | 19 |
| Therapeutic biologic | 17 |
| Prophylactic biologic | 1 |
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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Telmisartan Tablets | 3 | 1 | 4 |
| 2 | Lactulose Oral Solution | 2 | 1 | 34 |
| 3 | Perampanel Tablets | 2 | 1 | 2 |
| 4 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 5 | 头孢地尼干混悬剂 · No verified English name | 2 | 1 | 2 |
| 6 | Cytarabine for Injection | 2 | 1 | 2 |
| 7 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 8 | Avanafil Tablets | 2 | 1 | 2 |
| 9 | 中长链脂肪乳/氨基酸(16)/葡萄糖(16%)注射液 · No verified English name | 1 | 1 | 0 |
| 10 | Nintedanib Esilate Soft Capsules | 1 | 1 | 6 |
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
98 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | Chongqing Sai Wei Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 3 | Takeda Pharmaceuticals International AG Ireland Branch | 4 | 2 | 0 |
| 4 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 3 | 1 | 0 |
| 5 | Hebei Shan Mu Shi Pharma Co., Ltd. romanized | 3 | 1 | 3 |
| 6 | Anhui Jin Ma Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 7 | Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 8 | Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized | 2 | 2 | 0 |
| 9 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 2 | 2 | 2 |
| 10 | Rui Yang Pharmaceutical Co., Ltd. romanized | 2 | 2 | 2 |
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
39 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/08Import · Class 1 | DS-7300a · No verified English nameJXSL2400087 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD |
| 2024/05/08Import · Class 2.2 | Ropeginterferon alfa-2b (P1101) 注射液 · No verified English nameJXSL2400086 | PharmaEssentia Corporation; PharmaEssentia Biotechnology(Beijing)Company limited |
| 2024/05/08Import · Class 1 | Relatlimab注射液 · No verified English nameJXSL2400085 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/05/08Import · Class 1 | BI 1810631 片 · No verified English nameJXHL2400099 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2024/05/08Generic · Class 3 | Lidocaine CataplasmsCYHS2401368 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2401361 | Fujian Xin Di Pharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | Cimetidine InjectionCYHS2401360 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | 盐酸洛美沙星滴眼液 · No verified English nameCYHS2401352 | Jiangsu Guang Cheng Pharma Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2401351 | Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2401349 | Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2401348 | Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2401340 | Sui Cheng Pharma Co., Ltd. romanized |
| 2024/05/08Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2400083 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2024/05/08New drug · Class 1 | HBM9027注射液 · No verified English nameCXSL2400289 | He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/05/08New drug · Class 1 | AFN0328注射液 · No verified English nameCXSL2400288 | Hefei A Fa Na Bio Technology Co., Ltd. romanized; Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized; Hefei A Fa Na An Ke Bio Technology Co., Ltd. romanized |
| 2024/05/08New drug · Class 1 | NTQ3617片 · No verified English nameCXHL2400432 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/05/08New drug · Class 1 | NTQ3617片 · No verified English nameCXHL2400431 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/05/08New drug · Class 1 | NTQ3617片 · No verified English nameCXHL2400430 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/05/08New drug · Class 1 | SJP-0132滴眼液 · No verified English nameCXHL2400429 | Qian Shou Pharmaceutical Technology (Beijing) Co., Ltd. romanized |
| 2024/05/08New drug · Class 1 | HP560片 · No verified English nameCXHL2400428 | Hai Chuang Pharma Co., Ltd. romanized |
| 2024/05/08New drug · Class 1 | HP560片 · No verified English nameCXHL2400427 | Hai Chuang Pharma Co., Ltd. romanized |
| 2024/05/07Import · Class 1 | Fitusiran注射液 · No verified English nameJXHS2400034 | Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd. |
| 2024/05/07Import · Class 1 | Fitusiran注射液 · No verified English nameJXHS2400033 | Genzyme Corporation; Vetter Pharma-Fertigung GmbH & Co. KG; Sanofi (China) Investment Co. Ltd. |
| 2024/05/07Import · Class 1 | RO7434656注射液 · No verified English nameJXHL2400098 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/05/07Import · Class 2.2 | Upadacitinib口服溶液 · No verified English nameJXHL2400097 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/05/07Import · Class 2.2 | Upadacitinib口服溶液 · No verified English nameJXHL2400096 | AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd. |
| 2024/05/07Generic · Class 3 | Minoxidil LinimentCYHS2401338 | Xian De Li Bio Chemical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401337 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2401336 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/05/07Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2401335 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
9 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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