YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 251 drug applications between 4 October 2023 and 10 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 50 drug names.
2023/10/04 – 2023/10/10
- New acceptances this week
- 251
- Drugs with new generic filings (by drug name, de-duplicated)
- 50
- 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
251filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| Generic | 60 |
| New drug | 46 |
| Import re-registration | 14 |
| Unspecified | 9 |
| Import | 8 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| Therapeutic biologic | 35 |
| TCM | 32 |
| Prophylactic biologic | 3 |
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
50 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Clindamycin Phosphate Topical Solution | 2 | 1 | 1 |
| 2 | Lacosamide Tablets | 2 | 1 | 0 |
| 3 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
| 4 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 5 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 6 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 7 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 8 | Iopromide Injection | 2 | 1 | 27 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Calcium Gluconate in Sodium Chloride Injection | 2 | 1 | 5 |
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
153 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 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 5 | Jiangsu Xin Yuan Su Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Janssen-Cilag SpA | 4 | 2 | 0 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
| 8 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 4 | 2 | 1 |
| 9 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 10 | Sanofi-Aventis Deutschland GmbH | 4 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/10Import · Class 1 | 巴托利单抗注射液 · No verified English nameJXSL2300175 | DRAGON MERIT HOLDINGS LIMITED; CSPC Zhongqi Pharmaceutical Technology(Shijiazhuang). Ltd. |
| 2023/10/10Import · Class 1 | TIN816输注用粉末 · No verified English nameJXSL2300174 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/10/10Import · Class 1 | Capivasertib片 · No verified English nameJXHS2300096 | AstraZeneca UK Limited; AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/10/10Import · Class 1 | Capivasertib片 · No verified English nameJXHS2300095 | AstraZeneca UK Limited; AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/10/10Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302681 | Jinan Tong Lu Pharmaceuticals Technology Development Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/10/10Generic · Class 3 | Nicorandil for InjectionCYHS2302680 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hebei Ai Er Hai Tai Pharmaceutical Co., Ltd. romanized |
| 2023/10/10Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2302671 | Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized; Hubei Wu Shi Pharma Co., Ltd. romanized |
| 2023/10/10Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2302670 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/10/10Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2302669 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/10/10Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2302668 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/10/10Generic · Class 3 | 复方聚乙二醇电解质散(3350) · No verified English nameCYHS2302667 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized |
| 2023/10/10Generic · Class 3 | Valsartan Oral SolutionCYHL2300127 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | 注射用HC010 · No verified English nameCXSL2300679 | Shanghai Hong Cheng Pharma Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2301071 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/10/10New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2301070 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/10/10New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2301069 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/10/10New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2301068 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2023/10/10New drug · Class 1 | HEC192334片 · No verified English nameCXHL2301067 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | HEC192334片 · No verified English nameCXHL2301066 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | HEC192334片 · No verified English nameCXHL2301065 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2023/10/10New drug · Class 2.3 | SMF-210 · No verified English nameCXHL2301064 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2023/10/10New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2301063 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2301062 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | JMKX003142片 · No verified English nameCXHL2301061 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/10/10New drug · Class 1 | HX-100101-1注射液 · No verified English nameCXHL2301060 | Hong Xu Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized; Hong Xu Biopharmaceuticals Technology (Zhejiang) Co., Ltd. romanized |
| 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 |
46 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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