YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 334 drug applications between 2 December 2023 and 8 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 53 drug names.
2023/12/02 – 2023/12/08
- New acceptances this week
- 334
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- 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
334filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 72 |
| New drug | 47 |
| Import | 32 |
| Unspecified | 10 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 225 |
| TCM | 53 |
| Therapeutic biologic | 48 |
| Biologic | 7 |
| 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
53 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 2 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 3 | Diprophylline Injection | 2 | 2 | 7 |
| 4 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 5 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 6 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 7 | Agomelatine Tablets | 2 | 2 | 8 |
| 8 | Folic acid injection | 2 | 1 | 1 |
| 9 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 10 | Lacosamide Tablets | 2 | 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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Lan Yun Zhi He Bio Technology Co., Ltd. romanized | 20 | 17 | 0 |
| 2 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 4 | Novo Nordisk A/S | 7 | 2 | 0 |
| 5 | Hainan Ying Da Run Ze Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 5 | 4 | 5 |
| 7 | AstraZeneca AB | 5 | 2 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 10 | Janssen Research & Development LLC | 4 | 2 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/12/08Import · Class 2.2 | 埃万妥单抗注射液 · No verified English nameJXSS2300088 | Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd. |
| 2023/12/08Import · Class 1 | RAS突变的新生抗原多肽肿瘤疫苗 · No verified English nameJXSL2300218 | Targovax Solutions AS; IOVAXIS THERAPEUTICS |
| 2023/12/08Import · Class 1 | Camonsertib胶囊 · No verified English nameJXHL2300307 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2023/12/08Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2300306 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/12/08Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2300305 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/12/08Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2300304 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/12/08Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2300303 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/12/08Import · Class 1 | KarXT胶囊 · No verified English nameJXHL2300302 | Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd |
| 2023/12/08Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2303400 | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2023/12/08Generic · Class 3 | Minoxidil LinimentCYHS2303393 | Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/12/08Generic · Class 3 | Minoxidil LinimentCYHS2303392 | Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/12/08Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2303390 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | QX007N注射液 · No verified English nameCXSL2300850 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | 注射用HS-20089 · No verified English nameCXSL2300849 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2300848 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | 注射用PRO1107 · No verified English nameCXSL2300847 | Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | PT886 · No verified English nameCXSL2300846 | Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | JMKX003561颗粒 · No verified English nameCXHL2301357 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | JMKX003561颗粒 · No verified English nameCXHL2301356 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/12/08New drug · Class 1 | TL938胶囊 · No verified English nameCXHL2301355 | Suzhou Tao Lve Bio Technology Co., Ltd. romanized |
| 2023/12/08New drug · Class 2.2 | 他达拉非口服冻干片 · No verified English nameCXHL2301354 | Beijing Dong Shan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/08New drug · Class 2.2 | 他达拉非口服冻干片 · No verified English nameCXHL2301353 | Beijing Dong Shan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/12/07Import · Class 3.1 | 莫妥珠单抗注射液 · No verified English nameJXSS2300087 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2023/12/07Import · Class 3.1 | 莫妥珠单抗注射液 · No verified English nameJXSS2300086 | Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd. |
| 2023/12/07Generic · Class 3 | Foscarnet Sodium InjectionCYHS2303384 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Diprophylline InjectionCYHS2303383 | Ze Tian (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2023/12/07Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303382 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2303381 | Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Diprophylline InjectionCYHS2303378 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/12/07Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303377 | Hubei Jin Yao Pharma Co., Ltd. romanized |
62 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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