YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 371 drug applications between 12 September 2023 and 18 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 45 drug names.
2023/09/12 – 2023/09/18
- New acceptances this week
- 371
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
371filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| New drug | 65 |
| Generic | 62 |
| Import | 25 |
| Unspecified | 14 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| TCM | 62 |
| Therapeutic biologic | 44 |
| Prophylactic biologic | 7 |
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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Famotidine Injection | 4 | 2 | 8 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 3 | 3 | 23 |
| 3 | Vortioxetine Hydrobromide Tablets | 3 | 2 | 10 |
| 4 | 利伐沙班颗粒 · No verified English name | 2 | 1 | 2 |
| 5 | Omeprazole and Sodium Bicarbonate Capsules | 2 | 1 | 0 |
| 6 | Pregabalin Oral Solution | 2 | 1 | 5 |
| 7 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 8 | Oxacillin Sodium for Injection | 2 | 1 | 13 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Bromfenac Sodium Eye Drops | 2 | 1 | 7 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 17 | 1 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 14 | 10 | 2 |
| 3 | Henan Yue Ren Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 4 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 5 | Bard Pharmaceuticals Limited | 9 | 9 | 0 |
| 6 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 7 | Shanghai Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangdong Xin Bao Pharma Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized | 5 | 3 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300231 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300230 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2300229 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片 · No verified English nameJXHL2300228 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/18Import · Class 1 | LOXO-435片 · No verified English nameJXHL2300227 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/09/17New drug · Class 1 | 艾帕洛利单抗注射液 · No verified English nameCXSS2300077 | Qilu Pharmaceutical Co., Ltd. |
| 2023/09/16Import · Class 2.4 | 米罗那非片 · No verified English nameJXHL2300226 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2023/09/16Import · Class 2.4 | 米罗那非片 · No verified English nameJXHL2300225 | AriBio Co. Ltd.; Panacro (Hefei) Pharmaceutical Technology Co. Ltd. |
| 2023/09/16Generic · Class 3 | Famotidine InjectionCYHS2302501 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/09/16Generic · Class 3 | Famotidine InjectionCYHS2302500 | Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/09/16Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2302498 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/09/16Generic · Class 3 | Omeprazole and Sodium Bicarbonate CapsulesCYHS2302497 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/09/16New drug · Class 1 | 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2300628 | Rui Jian Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized; Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/16New drug · Class 1 | SKG0201注射液 · No verified English nameCXSL2300627 | Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2023/09/16New drug · Class 1 | SHR2554片 · No verified English nameCXHL2301008 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/16New drug · Class 1 | SYH2053注射液 · No verified English nameCXHL2301007 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/09/15Import · Class 1 | SAR442168 · No verified English nameJXHL2300224 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/09/15Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302491 | Hai Men Pu Shi Pharmaceuticals Co., Ltd. romanized |
| 2023/09/15Generic · Class 3 | Dexketoprofen Trometamol InjectionCYHL2300118 | Zhong Run Pharma Co., Ltd. romanized |
| 2023/09/15Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2300117 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.3 | 菖麻熄风片 · No verified English nameCXZL2300061 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300626 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2300625 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | C-13-60细胞制剂 · No verified English nameCXSL2300624 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300623 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300622 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | 注射用重组WNV-HCD86 · No verified English nameCXSL2300621 | Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | MC-1-50细胞制剂 · No verified English nameCXSL2300620 | Chongqing Jing Zhun Bio Technology Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | BGT-004胶囊 · No verified English nameCXHL2301006 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/15New drug · Class 1 | BGT-004胶囊 · No verified English nameCXHL2301005 | Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
87 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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