YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 498 drug applications between 29 January 2023 and 4 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 145, covering 103 drug names.
2023/01/29 – 2023/02/04
- New acceptances this week
- 498
- Drugs with new generic filings (by drug name, de-duplicated)
- 103
- 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
498filings, 145 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 210 |
| Generic | 145 |
| New drug | 95 |
| Import | 22 |
| Import re-registration | 18 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 399 |
| Therapeutic biologic | 51 |
| TCM | 44 |
| Prophylactic biologic | 4 |
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
103 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 5 | 3 | 23 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Phenylephrine Hydrochloride Injection | 4 | 2 | 5 |
| 4 | Minoxidil Topical Solution | 4 | 2 | 0 |
| 5 | Calcium Levofolinate Injection | 4 | 1 | 0 |
| 6 | Famotidine Injection | 3 | 3 | 8 |
| 7 | Phloroglucinol Injection | 3 | 3 | 2 |
| 8 | Acetylcysteine Granules | 3 | 2 | 4 |
| 9 | Peramivir Injection | 3 | 2 | 7 |
| 10 | Amoxicillin Sodium for Injection | 3 | 1 | 0 |
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
288 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 13 | 12 | 0 |
| 2 | Anhui Pioneer Pharmaceutical Co., Ltd | 9 | 3 | 0 |
| 3 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 8 | 3 | 0 |
| 4 | Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 5 | Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Sichuan Kelun Pharmaceutical Co., Ltd. | 7 | 5 | 1 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 7 | 4 | 1 |
| 8 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 9 | Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 6 | 6 |
| 10 | Bracco Imaging Italia s.r.l. | 6 | 1 | 0 |
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
175 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/04Import · Class 3.1 | 尘螨变应原舌下片 · No verified English nameJXSS2300015 | ALK-Abelló A/S; Catalent UK Swindon Zydis Limited |
| 2023/02/04Import · Class 3.1 | 注射用tisotumab vedotin · No verified English nameJXSL2300032 | Seagen Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/02/04Import · Class 1 | Milvexian片 · No verified English nameJXHL2300019 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/02/04Generic · Class 3 | Mesalamine extended release capsulesCYHS2300356 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2300355 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Oxaliplatin InjectionCYHS2300352 | Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2300349 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Famotidine InjectionCYHS2300342 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2300340 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/02/04Generic · Class 3 | Metformin Hydrochloride Extended-release TabletsCYHS2300337 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Calcium Levofolinate InjectionCYHS2300334 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Calcium Levofolinate InjectionCYHS2300333 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Calcium Levofolinate InjectionCYHS2300332 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Calcium Levofolinate InjectionCYHS2300331 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | HG004眼用注射液 · No verified English nameCXSL2300088 | Hui Da (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | HG004眼用注射液 · No verified English nameCXSL2300087 | Hui Da (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | 注射用XYD-9668-198抗体偶联剂 · No verified English nameCXSL2300086 | Kun Shan Xin Yun Da Bio Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | 9MW2821 · No verified English nameCXSL2300085 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | SIM1811-03注射液 · No verified English nameCXSL2300084 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2300083 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | 注射用9MW2921 · No verified English nameCXSL2300082 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2300081 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/04New drug · Class 2.2 | VGT-I01 · No verified English nameCXSL2300080 | Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | BD111注射液 · No verified English nameCXSL2300079 | Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TLL-018缓释片 · No verified English nameCXHL2300172 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TLL-018缓释片 · No verified English nameCXHL2300171 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TLL-018缓释片 · No verified English nameCXHL2300170 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TLL-018缓释片 · No verified English nameCXHL2300169 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | TLL-018缓释片 · No verified English nameCXHL2300168 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2023/02/04New drug · Class 1 | SHR0302口服溶液 · No verified English nameCXHL2300167 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
145 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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