YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 159 drug applications between 3 October 2023 and 9 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 34 drug names.
2023/10/03 – 2023/10/09
- New acceptances this week
- 159
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- 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
159filings, 42 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 61 |
| Generic | 42 |
| New drug | 33 |
| Import re-registration | 13 |
| Unspecified | 5 |
| Import | 4 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 108 |
| Therapeutic biologic | 30 |
| TCM | 20 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lacosamide Tablets | 2 | 1 | 0 |
| 2 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 3 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 4 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 5 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 6 | Iopromide Injection | 2 | 1 | 27 |
| 7 | Minoxidil Liniment | 2 | 1 | 52 |
| 8 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
| 9 | Lactulose Oral Solution | 1 | 1 | 34 |
| 10 | Ebastine Oral Solution | 1 | 1 | 9 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 3 | 1 |
| 2 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 3 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 4 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 5 | Sanofi-Aventis Deutschland GmbH | 4 | 1 | 0 |
| 6 | Name not romanized | 4 | 1 | 0 |
| 7 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Chugai Pharmaceutical Co. Ltd | 3 | 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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/09Import · Class 1 | DS-1062a · No verified English nameJXSL2300173 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2023/10/09Import · Class 2.4 | 氯马昔巴特口服溶液 · No verified English nameJXHS2300094 | Mirum Pharmaceuticals Inc.; Halo Pharmaceutical Canada Inc.; CANbridge (Suzhou) Bio-pharma Co. Ltd. |
| 2023/10/09Generic · Class 3 | Ebastine Oral SolutionCYHS2302665 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302663 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2302661 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2023/10/09Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2302660 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2023/10/09Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2302659 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302657 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/10/09Generic · Class 3 | Digoxin TabletsCYHS2302653 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2302645 | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Minoxidil LinimentCYHS2302644 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Minoxidil LinimentCYHS2302643 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Aceclofenac TabletsCYHS2302640 | Henan Nuo Mei Pharma Co., Ltd. romanized |
| 2023/10/09Generic · Class 3 | Dapsone GelCYHL2300126 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 注射用BB-1710 · No verified English nameCXSL2300678 | Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2300677 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSL2300676 | Shanghai Duo Mi Rui Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 3.2 | 注射用重组人C1酯酶抑制剂 · No verified English nameCXSL2300673 | Chengdu Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2300672 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 注射用AP026 · No verified English nameCXSL2300671 | An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300670 | Hangzhou Yi Wen Sai Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | 注射用双利司他 · No verified English nameCXHS2300092 | Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/10/09New drug · Class 1 | ND-003片 · No verified English nameCXHL2301059 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | ND-003片 · No verified English nameCXHL2301058 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | CAN1012 注射液 · No verified English nameCXHL2301057 | Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | CAN1012 注射液 · No verified English nameCXHL2301056 | Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | CAN1012 注射液 · No verified English nameCXHL2301055 | Kang Wei (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | SIR2446M片 · No verified English nameCXHL2301054 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | SIR2446M片 · No verified English nameCXHL2301053 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/10/09New drug · Class 1 | NH300231肠溶片 · No verified English nameCXHL2301052 | Jiangsu En Hua Pharma Co., Ltd. romanized; Shanghai Shu Jing Bio Technology Co., Ltd. romanized |
21 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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